Christine

THURSDAY, Sept. 6 (HealthDay News) -- The introduction of filtered and low-tar cigarettes in the 1950s coincided with a steady rise in the incidence of a once-rare type of lung cancer that's now the most common form of the disease, a new study finds. Decades ago, squamous cell carcinoma was the most common form of lung cancer. But between 1950 and 2007, adenocarcinoma became the most frequently diagnosed lung malignancy, as the market share of filtered cigarettes soared from just 1 percent to almost 100 percent, the study authors said. Described as a "correlation of evidence," the apparent link was uncovered by study author Dr. Gary M. Strauss, medical director of the lung cancer program at Tufts-New England Medical Center in Boston. He presented the findings Wednesday at the 12th World Conference on Lung Cancer, in Seoul, South Korea. Strauss and his colleagues suggest that the impact of filtered cigarettes on adenocarcinoma rates is due to the introduction of filter vents in filtered cigarettes, making it easier to draw in smoke. These vents allow smokers to take bigger and deeper puffs, thereby inhaling carcinogens further into the bronchial passages and lungs. "The rise of adenocarcinoma is consistent with changes in cigarette design and composition -- which the cigarette industry indicated were safer -- that they introduced in response to mounting evidence that smoking causes other forms of lung cancer," Strauss said. "And so the point is that the tobacco industry, through how they changed the cigarette over time and deceived the public for decades about its safety, has created an epidemic," he added. Philip Morris USA's media affairs manager, David Sutton, said he could not comment on the findings. "We cannot comment on a study we have not had a chance to review. Smoking is addictive and causes serious diseases. There is no such thing as a safe cigarette," he said. To explain the dramatic rise in diagnoses of adenocarcinoma, Strauss and his team of U.S, researchers first analyzed data concerning cancer rates that had been collected between 1975 and 2003 through the National Cancer Institute's "Surveillance Epidemiology and End Results" (SEER) program. The study authors focused on information covering more than 307,000 black and white lung cancer patients, 75 percent of whom were 60 or older at the time of their diagnosis. And they focused on six time periods: 1975-1979, 1980-84, 1985-89, 1990-94, 1995-99 and 2000-03. Statistics on four major types of lung cancer -- adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and small cell carcinoma -- were tallied to reveal how common each disease had been at the six different time periods. The first three cancers fall into the "non-small cell" category of lung disease that accounts for about 85 percent of all lung cancers in the United States, according to the American Cancer Society. The SEER figures showed that by the years 2000 to 2003, 47 percent of all lung cancers were adenocarcinoma, Strauss and his team observed. While American Cancer Society numbers currently place adenocarcinoma at 40 percent of all cases, both ACS and SEER data confirm that adenocarcinoma is by far the most prevalent form of lung cancer today --- regardless of race, age and gender. In 1950, adenocarcinoma constituted just 5 percent of all lung cancer cases, and a diagnosis of the disease was not typically considered to be due to cigarette smoking. Back in the mid-20th century, most lung cancer cases were squamous cell, the researchers said. But the SEER data illustrate a sharp rise in adenocarcinoma cases beginning in the 1960s. And from the 1975-79 period to the 1995-99 period, adenocarcinoma cases skyrocketed 62 percent. Adenocarcinoma surpassed squamous cell carcinoma as the most common form of lung cancer among women in the 1975-79 period and among men during the 1980-84 period. Because the SEER database did not collect information on smoking demographics, the researchers said they subsequently sifted through a wide range of additional data covering 50 years of U.S. cigarette production and consumer habits in search of an underlying explanation. Strauss and his colleagues said they found that the wide-scale adoption of filtered and low-tar cigarettes closely tracked the jump in adenocarcinoma rates. Filtered cigarettes went from 1 percent of the U.S. market in 1950 to 64 percent by 1964. By 1986, filtered cigarettes had captured 95 percent of the market; by 2007 that figure was 98 percent. "And while adenocarcinoma of the lung has always existed, it is now the most common form of lung cancer, and probably the second most common cause of cancer death," said Strauss. "Probably more people die specifically of smoking-related adenocarcinoma today than die of colon cancer." "So while nothing is really new here, we're putting it all together," he said. And what emerges, he added, is the story of a tobacco industry that years back actively changed its product to minimize its known connection to certain types of cancers, thereby giving birth to a whole new carcinogenic threat and an even bigger lung cancer killer. "And so now I'm hoping that there will be a recognition that the tobacco industry actually created this deadly epidemic of smoking-related adenocarcinoma through decades of deception," Strauss said. The results of several other international studies were also presented this week at the South Korea conference, including a Norwegian finding that hand-rolled cigarettes are more carcinogenic than pre-packaged cigarettes, resulting in a higher risk for lung cancer. Another study, out of Japan, showed that people with a family history of lung cancer are more likely to develop the disease -- particularly squamous cell disease -- later in life. However, a general family history of cancer was not associated with an increased risk for lung cancer

Sept. 4) - Consumers, not just factory workers, may be in danger from fumes from buttery flavoring in microwave popcorn, according to a warning letter to federal regulators from a doctor at a leading lung research hospital. A pulmonary specialist at Denver's National Jewish Medical and Research Center has written to federal agencies to say doctors there believe they have the first case of a consumer who developed lung disease from the fumes of microwaving popcorn several times a day for years. "We cannot be sure that this patient's exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease," cautioned Dr. Cecile Rose. "However, we have no other plausible explanation." The July letter, made public Tuesday by a public health policy blog, refers to a potentially fatal disease commonly called popcorn lung that has been the subject of lawsuits by hundreds of workers at food factories exposed to chemicals used for flavoring. In response to Rose's finding, the Flavor and Extract Manufacturers Association issued a statement Tuesday recommending that its members reduce "to the extent possible" the amount of diacetyl in butter flavorings they make. It noted that diacetyl is approved for use in flavors by the federal Food and Drug Administration. One national popcorn manufacturer, Weaver Popcorn Co. of Indianapolis, said last week it would replace the butter flavoring ingredient because of consumer concern. Congress has also been debating new safety measures for workers in food processing plants exposed to diacetyl. The FDA said in an e-mail it is evaluating Rose's letter and "carefully considering the safety and regulatory issues it raises." Fred Blosser, spokesman for the National Institute for Occupational Safety and Health, said it is the first case the institute has seen of lung disease apparently linked to popcorn fumes outside the workplace. The occupational safety arm of the Centers for Disease Control and Prevention said it is working on a response to the letter. William Allstetter, spokesman for National Jewish Medical, confirmed the letter was sent by Rose, a specialist in occupational and environmental lung diseases and director of the hospital's Occupational and Environmental Medicine Clinic. "There have been no other cases that we know of other than the industrial occupational ones," Allstetter said. Rose acknowledged in the letter that it is difficult to confirm through one case that popping buttered microwave popcorn at home can cause lung disease. However, she said she wanted to alert regulators of the potential public health implications. Rose said the ailing patient, a man whom she wouldn't identify, consumed "several bags of extra butter flavored microwave popcorn" every day for several years. He described progressively worsening respiratory symptoms of coughing and shortness of breath. Tests found his ability to exhale was deteriorating, Rose said, although his condition seemed to stabilize after he quit using microwave popcorn. She said her staff measured airborne levels of diacetyl in the patient's home when he cooked the popcorn. The levels were "similar to those reported in the microwave oven exhaust area" at the quality assurance unit of the popcorn plant where the affected employees worked, she said. David Michaels, of the George Washington University School of Public Health, who first published Rose's letter on his blog, The Pump Handle, said the finding is another reason for federal regulators to crack down on diacetyl exposure by workers and consumers. "This letter is a red flag, suggesting that exposure to food flavor chemicals is not just killing workers, but may also be causing disease in people exposed to food flavor chemicals in their kitchens," Michaels wrote on his public health policy blog.

**Clinical benefit observed in over 60% of evaluable patients** SEOUL, South Korea, Sept. 4 -- Exelixis, Inc. today reported interim data from an ongoing phase 2 trial evaluating XL647 as first-line therapy for patients with non-small cell lung cancer (NSCLC). This open-label phase 2 trial is ongoing in previously untreated patients with stage IIIB or IV NSCLC who have adenocarcinoma histology and meet one of the following three criteria: Asian descent, female gender, or no or minimal smoking history. XL647 is administered orally, at a dose of 350 mg on Days 1-5 of repeated 14-day cycles. To date, over 60% of evaluable patients in the phase 2 study have had partial responses (PR) or stable disease (SD) as their best response. Importantly, responses have been observed in patients with and without activating mutations in the epidermal growth factor receptor (EGFR), a target of XL647. Activating mutations in EGFR have been associated with improved sensitivity to other EGFR inhibitors. Dr. Shirish Gadgeel of Karmanos Cancer Institute at Wayne State University presented the data today in a poster (Abstract P3-136) at the 12th International Association for the Study of Lung Cancer World Conference on Lung Cancer, which is being held in Seoul, South Korea. Key data points reported by Investigators: -- XL647 has demonstrated anti-tumor activity in patients with previously untreated NSCLC: >60% of evaluable patients experienced clinical benefit as their best response (8 PR and 11 SD out of 30 evaluable patients). -- Of the 8 patients who experienced partial responses, 4 had EGFR exon 19 deletions, 1 had an EGFR L858R mutation, and 3 were EGFR wild-type. -- All 6 patients with EGFR-activating mutations demonstrated clinical benefit (5 PR, 1 SD). -- XL647 is generally well tolerated in this patient population. The most frequently reported adverse events assessed as being related to XL647 were diarrhea, rash, fatigue, and nausea, all of which were Grade 1 or Grade 2 in severity. "The data reported today demonstrate that XL647 has potential utility in patient populations with both mutated and wild-type EGFR," said Dr. Shirish Gadgeel of Karmanos Cancer Institute at Wayne State University. "Importantly, the data highlight that patients to date appear to have milder EGFR-related side-effects -- rash and diarrhea -- than previously described with other EGFR inhibitors while retaining potent anti-tumor activity with durable responses and stable disease. Although these are early results, they provide a compelling rationale for expediting the full development of XL647 in non-small cell lung cancer." "These data suggest that XL647 has the potential for utility in patients with NSCLC who have an activating EGFR mutation and those with wild-type EGFRs. We believe these data support an aggressive clinical development strategy in first, second and third-line treatment as both a single agent and in combination with other therapies," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Moreover, new data from an ongoing phase 1 trial of XL647 suggest that daily dosing results in higher drug concentrations than those observed to date in this phase 2 study with intermittent dosing. We expect to complete this evaluation of both daily and intermittent dosing schedules soon in order to select the optimal regimen and dose for the late-stage development of XL647." The most frequently reported treatment-related adverse events (AEs) were Grade 1 and 2 diarrhea and fatigue, and Grade 1 nausea and rash. Six patients have had a maximum Grade 1 QTc interval prolongation, and 7 patients a maximum Grade 2; the increases were clinically asymptomatic and not associated with AEs or dose reduction or delay. One patient who experienced an event of asymptomatic Grade 3 QTc interval prolongation had ineligible baseline QTc values (Grade 2) and was withdrawn from the study. A total of 16 serious AEs were reported in 8 patients. 5 events in 4 patients were considered possibly or probably related to study drug: Grade 3 GI hemorrhage and duodenal ulcer in 1 patient, and Grade 3 pneumonia, Grade 4 pulmonary embolism, and Grade 2 haemoptysis. About XL647 XL647 is a potent inhibitor of receptor tyrosine kinases (RTKs) that are implicated in driving tumor proliferation and vascularization (blood vessel formation). XL647 inhibits EGFR, HER2 and VEGFR2. The compound has been optimized for high potency and oral bioavailability (using in vivo systems), demonstrates excellent activity in target-specific cellular functional assays and has shown sustained inhibition of target RTKs preclinically in vivo following a single oral dose. Two phase 2 trials in patients with NSCLC are ongoing. About Exelixis Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 2 and phase 1 clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Daiichi-Sankyo. For more information, please visit the company's web site at http://www.exelixis.com.

TORONTO (CP) — For Victoria Campbell, hope is a "beacon in the darkness" in her long, intense battle with cancer that began five years ago. The elementary school teacher was diagnosed with breast cancer in 2002, then colon cancer in 2005 - which metastasized to her liver. She has now just come through her third surgery for lung cancer. "Hope is a critical aspect, I find, with living with cancer," says the Saskatchewan native who moved to Toronto a few years ago. "We want to live a quality life no matter how long we have to live." "It's not the quantity, it's the quality," says Campbell, 56, who recently attended a workshop on hope at Wellspring, a national support group for people living with cancer. She likens hope to a light. "And light to me in healing is central," says Campbell. "Both the visual aspect of light entering into me and also the aspect of light and hope in terms of what is ahead for me - it is a beacon in the darkness." Eva Thurlow of Wellspring in Toronto says the seminar entitled "What Is Hope" looks at the personal meaning of hope and how cancer patients and their caregivers can remain resilient in the midst of change and challenge. Wellspring's programs are offered in conjunction with the Healing Journey Program, a support and coping skills regimen developed at the Ontario Cancer Institute/Princess Margaret Hospital in Toronto. The hope workshops are led by Dr. Claire Edmonds, who manages the Healing Journey Program at Princess Margaret and Wellspring. "Hope is about human dignity ... about carrying on even when circumstances are difficult," says Edmonds. For many patients diagnosed with cancer, hope becomes flexible and "moves with us through our journey," she says. Edmonds rhymes off the ways that hope emerges during illness and treatment. "I hope there are treatments for this. I hope that the chemotherapy works. I hope that there are going to be medications to help me deal with nausea." "I hope that I'm going to be well for the wedding. I hope that I'm just going to have eight months of chemo and then it will be gone." If the cancer comes back, hope re-emerges. "I hope I have time. I hope there are more treatments. When the treatments begin to run out, hope becomes I hope that the pain is manageable ... that I can have good days ... that I can spend time with my grandchild." "If we are hopeless, in a profound state of hopelessness, we'd probably be a suicide," Edmonds adds. "There just is no reason to move on." While there is no hard research on health outcomes related to hope, there is strong evidence of its benefits, says Denise Larsen, head of research at the Hope Foundation at the University of Alberta in Edmonton. The foundation conducts research into how hope might be fostered in individuals facing difficult circumstances such as cancer and heart attacks. "(Research) indicates that individuals with higher levels of hope actually appear to have neurochemistry that helps potentially to combat depression," Larsen says. "There's some research that suggests that those people with higher hope may actually live longer with terminal cancer ... we know for a fact they live better." "We understand now that hope is really about being able to envision a good future or a better future for oneself, and believing that that's possible." There are several things that people can do to make hope happen, and this is where workshops, like those at Wellspring and the Hope Foundation, come in. The Wellspring program has four steps, starting with basics like pain control, then moving on to mental states, social connections and spirituality. The first step, says Edmonds, is "adequate nutrition, adequate sleep, adequate pain control ... It's hard to be hopeful when you're hungry, tired and in pain." Level two concerns the mind and healthy thought management. There are ways of saying things to yourself and others that support hope and ways of saying them that support depression and hopelessness, says Edmonds. For example, "saying, I feel awful is different than saying I don't feel well today. (The latter) gives a spaciousness. I don't feel well today embodies hope. I could feel better tomorrow," she said. Healthy thought management, says Edmonds, can be attained through meditation and keeping a journal. Keeping a journal helps people to see what thoughts they are carrying with them and which ones they want to change, says Edmonds. The third step is thinking about social connections. "When we're stressed, we need people," says Edmonds. "Hopefulness is actually somewhat contagious in a good way, just like hopelessness is. You can bring people down in a group and you can bring people up." Lastly, for those who have a spiritual practice, it can connect them with places of peacefulness inside of themselves "so that they are not caught up in those anxious thoughts," says Edmonds. "They can sort of float a little bit." Campbell found the workshop to be uplifting. "By gathering and focusing on hope ... and having an opportunity to speak about it, I found it strengthened me," she says. What gives hope to Campbell on a daily basis? "When I awaken ... I'm just thankful that I have today, and hopeful that I'll have tomorrow in the same kind of way that I have today ... pain free." Also, "focusing on what I have as opposed to what I have not" gives her hope, as do the practices that keep her in the light - a journal, meditation, imagery visualization. "If I do those on a daily basis, I am filled with light and ... hope. If I don't ... my thoughts go the sadness that my life may not be as long as it would have been had this not developed." "With cancer life becomes so precious. I'm so acutely aware of everything." But sometimes, she said, her voice breaking, "you kind of wish it would just all go away."

You're welcome. And, thank you.

LEXINGTON, Ky. (AP) — Gay Brewer, the 1967 Masters champion who won 11 times on the PGA Tour, died Friday at his home after a fight with lung cancer. He was 75. Brewer, who retired from the Champions Tour in 2000, had been battling cancer since October, fiancee Alma Jo McGuire said. "It was incurable," she said. "It was easier on him and the family that it didn't go any longer than it did." Brewer won the 1967 Masters for his lone major title a year after he lost an 18-hole playoff to Jack Nicklaus. In 1966, Brewer three-putted the 72nd hole to fall into the playoff with Nicklaus and Tommy Jacobs. "We are deeply saddened by the loss of Gay Brewer," said Billy Payne, chairman of the Masters and Augusta National Golf Club. "Gay was a wonderful champion and individual and will be dearly missed in April. We express our heartfelt sympathy to his family." Brewer won the Canadian Open in 1972 at Cherry Hill Golf Club in Ridgeway, Ont. In June, Picadome Golf Course in Lexington, where Brewer learned to play, changed its name to honour him. Brewer played college golf at the University of Kentucky. "He was just really personable," McGuire said. "I don't know anybody who didn't like him." Brewer is survived by daughters Kelly Allen and Erin Provence and four grandchildren. McGuire said services would be Wednesday at Kerr Brothers Funeral Home in Lexington. "Gay was great," Tiger Woods said at the Deutsche Bank Championship. "Man, he told more stories and was just incredible to be around." Jim Thorpe and other Champions Tour players remembered Brewer's unique swing. "He was a great player in his day," he Thorpe said at the Champions Tour event at Pebble Beach. "Some people just can't be replaced and he was one of those guys. He was like the Sam Sneads and the (Ben) Hogans of the world. He was one of those guys who had a little bit of an unorthodox swing and that sort of stuff, but it worked for him." Bob Charles' children attended nursery school with Brewers' children in Dallas. "I played with him quite a bit," Charles said. "Of course, he was a major winner, the Masters. So he accomplished quite a bit in his lifetime with not a particularly classical golf swing. ... He was a good character and good for the game. ... I can't recall an anecdote, except in as much as he had an unusual, loopy golf swing. I guess that's what kind of stands out about in my memory about Gay more than anything." Gil Morgan remembered Brewer as a storyteller. "He was always so likable and a very jovial type of guy," Morgan said. "He would always want to sit down and want to talk with you, especially like in the Legends tournament and later in his lifetime. He always seem to like guy to sit down and tell stories."

PARIS, Sep. 4, 2007 -- Pharmaceutical company Sanofi-Aventis said seven trials of its Taxotere drug in treating non-small cell lung cancer showed a 'significant' improvement in overall survival rates versus existing treatments. Taxotere, an anti-cancer agent used in other treatments, is the company's fourth best-selling drug.

Science Daily — Arthritis of the knee may be the first sign of a type of lung cancer that is hard to treat in heavy smokers, suggests research published ahead of print in the Annals of the Rheumatic Diseases. The researchers reviewed the case notes of all patients with rheumatic disorders, diagnosed at one tertiary referral centre over six years. Between 2000 and 2005, more than 6500 new patients attended the clinic. Of these, 296 (4.4%) were cases of monoarthritis--inflammation in just one joint--of the knee. Among this group of patients, the knee arthritis, which was very mild, was the first sign of as yet undiagnosed non-small cell lung cancer in just under 2%. All the patients were middle aged men, who had been heavy smokers for most of their lives. But in every case, the lung cancer was operable, and once the cancerous tissue had been removed, the knee symptoms subsided. Non-small cell lung cancer is linked to other conditions, which feature abnormal growths, in up to 20 per cent of cases, say the authors. And spread to the bones occurs in around one in five cases. But the authors note that it has not so far been linked to arthritis. Non-small cell lung cancer is particularly difficult to treat unless caught early, and in over half the cases diagnosed, the disease is already advanced. Features that could act as early warning signs are therefore especially important, say the authors. Note: This story has been adapted from a news release issued by BMJ Specialty Journals.

SOUTH SAN FRANCISCO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that updated results of its Phase 2 clinical trial of picoplatin confirm and extend the previously announced interim data analysis, which demonstrated a survival benefit in patients with recurrent small cell lung cancer (SCLC) who have relapsed within six months of first-line therapy. The company also for the first time announced the median one-year survival rate of 17.6 percent in the Phase 2 population of mostly platinum-refractory and -resistant patients studied in this trial. Picoplatin, the Company's lead product candidate, is currently being evaluated in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPEAR trial is being conducted in platinum-refractory, -resistant, and -sensitive SCLC patients who have failed or relapsed from initial therapy within six months of initial treatment and is comparing picoplatin treatment with best supportive care to best supportive care alone. The median overall survival is approximately 17 to 22 weeks for patients with recurrent SCLC who are treated with existing second-line chemotherapies, according to the 2007 National Comprehensive Cancer Network practice guidelines. "These updated Phase 2 data are consistent with earlier studies of picoplatin in this difficult-to-treat patient population and compare favorably with the median survival for the entire population of relapsed patients who receive other second-line chemotherapy," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "These results are promising because patients with platinum-resistant and -refractory small cell lung cancer have very limited treatment options. They typically experience rapid disease progression and low overall survival following treatment with existing chemotherapies, which have significant toxicities." The updated picoplatin Phase 2 data were presented during a poster discussion session at the International Association for the Study of Lung Cancer's (IASLC) 12th World Conference on Lung Cancer in Seoul, Korea. Additional Phase 2 Study Findings In addition to the overall and one-year survival findings, the updated analysis of results from the open-label, multi-center Phase 2 trial showed that the disease control rate was 48.1 percent in the 77 evaluable patients. This is similar to that observed with currently available treatments, but with a more manageable side effect profile and less frequent administration. At the time of the updated analysis, 63 patients had died from disease progression. The most common side effects were hematologic and included thrombocytopenia, anemia and neutropenia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred. Pivotal Phase 3 SPEAR Trial Design Poniard's ongoing international, multi-center, randomized, controlled SPEAR trial is comparing picoplatin plus best supportive care to best supportive care alone to evaluate the efficacy of picoplatin after relapse. Best supportive care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side effects of palliative cancer treatments. The primary efficacy endpoint is overall survival, with overall response rates, progression-free survival and disease control also being evaluated. The trial, which is enrolling patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum chemotherapy (cisplatin or carboplatin), is being conducted at clinical sites in Europe and India. "Since the initiation of the SPEAR trial in the second quarter of 2007, we have made significant progress in opening approximately 100 clinical sites and in treating patients," said David A. Karlin, M.D., senior vice president, clinical development and regulatory affairs for Poniard. "We anticipate reaching our enrollment target in the first half of 2008, potentially supporting a New Drug Application filing in 2009." About Picoplatin Picoplatin is a new generation platinum chemotherapy agent. It was designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemotherapeutics. Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC. In addition to the ongoing SPEAR trial, Poniard is also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial in combination with docetaxel (Taxotere®) and prednisone in patients with metastatic hormone-refractory prostate cancer. About Small Cell Lung Cancer SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options. The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute. The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer. SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment. There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin. No new drugs have been approved by the FDA for the treatment of platinum-resistant or -refractory SCLC in nearly a decade.

TUSTIN, Calif., Sept. 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing targeted monoclonal antibodies for the treatment of cancer and hepatitis C virus infection, today reported that researchers have published a new study in a lung cancer model showing that the combination of a mouse equivalent of bavituximab and radiation is significantly more effective in reducing tumor growth than either therapy alone. The study was published in the September 1 issue of Clinical Cancer Research. Bavituximab, Peregrine's lead anti-phosphatidylserine (anti-PS) immunotherapy, is currently in clinical trials for the treatment of solid tumors including lung cancer. "This new publication further supports the concept that radiation therapy and bavituximab may work synergistically to treat solid tumors." said Steven W. King, president and CEO of Peregrine. "We are particularly pleased to see these positive results in a model of radiation resistant lung cancer, by far the leading cause of U.S. cancer deaths. This is the latest in a series of preclinical studies that have demonstrated the potential of either radiation or chemotherapy to enhance bavituximab's anti-tumor effects. We look forward to evaluating a combination of bavituximab plus radiation therapy in future clinical studies." Peregrine completed a pilot Phase I study evaluating bavituximab in combination with chemotherapy in advanced cancer patients earlier this year and reported promising results. Based on these results, Peregrine recently submitted a Phase II clinical protocol to test bavituximab plus carboplatin/paclitaxel in lung cancer patients and plans to file several additional combination therapy clinical protocols this year. Lung cancer is the leading cause of cancer deaths in the U.S. with a 5-year survival rate of only about 15%. With more than one million new cases diagnosed worldwide each year, lung cancer is also the leading cause of cancer deaths globally. About half of all lung cancer patients receive radiation therapy, but many become resistant to its tumor-killing effects. In this study, researchers tested a bavituximab equivalent combined with radiation therapy in a radiation-resistant mouse model of lung cancer. The UT Southwestern Medical Center researchers found that in this lung cancer model, radiation therapy increased by over six-fold the percentage of tumor blood vessel cells that exposed bavituximab's PS target on the external surfaces. As a result, more of the bavituximab equivalent antibodies became concentrated in the tumor blood vessels. This increased localization may have contributed to the finding that the density of tumor blood vessels was reduced by more than 90% and tumor growth was reduced by 80% in animals treated with combination therapy, significantly greater efficacy than was achieved with either treatment alone. "Approximately 50% of all cancer patients receive radiation therapy, so these findings could potentially apply to millions of patients," noted Dr. Philip Thorpe, professor of pharmacology at UT Southwestern and a member of Peregrine's Scientific Resource Board. "We are also pleased that these results confirm our previous work that demonstrated that the enhanced therapeutic effects of bavituximab combination therapy do not appear to be accompanied by an increase in side effects, offering the possibility of more effective and less toxic anti-cancer regimens." Bavituximab is a monoclonal antibody that binds to a phospholipid called phosphatidylserine that is normally located inside normal cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is believed to help mobilize the body's immune system to destroy the blood vessels needed for tumor growth and spread. In a Phase lb trial in advanced cancer patients bavituximab plus chemotherapy appeared to have a safety profile consistent with chemotherapy alone and showed positive signs of clinical activity. In the study, objective response or disease stabilization was achieved in 50% of patients evaluated for tumor response. A protocol for a Phase ll trial of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) has been filed and is currently undergoing regulatory review. Bavituximab is also in clinical trials in the U.S. in patients with advanced solid tumors and in patients co-infected with HCV and HIV. The study, titled 'Radiation-Enhanced Vascular Targeting of Human Lung Cancers in Mice with a Monoclonal Antibody That Binds Anionic Phospholipids," was co-authored by Philip Thorpe, Jin He, and Troy A. Luster. The research was funded with assistance from the Gillson Longenbaugh Foundation and the American Cancer Society.

LONDON (Thomson Financial) - Eli Lilly and Company said two new studies conducted in Asia have demonstrated the clinical benefit of its lung cancer drug Alimta. The company said the data presented at the 12th World Conference on Lung Cancer provide further support of the efficacy of Alimta in treating non-small cell lung cancer, the world's most common form of cancer. Alimta is currently indicated for the second-line treatment of non-small cell lung cancer in more than 85 countries. In one study, a Japanese multicenter, randomised Phase II trial, pretreated patients with locally advanced or metastatic NSCLC demonstrated more than 12 months of median survival time when treated with Alimta. 'This is data showing that Alimta not only provides excellent outcomes but also a favourable quality of life in pretreated patients with non-small cell lung cancer,' said Dr Kaoru Kubota (nyse: KUB - news - people ) of the National Cancer Center Hospital East in Kashiwa, Japan and the study's principal investigator.

MISSISSAUGA, ON, Sept. 4 /PRNewswire-FirstCall/ - YM BioSciences Inc. , an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced positive preliminary results from the first two cohorts of the Phase I part of a Phase I/II trial of nimotuzumab in combination with radiation for the treatment of non-small-cell lung cancer (NSCLC) patients who are unsuitable for radical chemotherapy. The data were reported on September 5th in a poster presentation at the 12th World Conference on Lung Cancer in Seoul, Korea. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). "While preliminary, these results are compelling because we observed clinical benefit (Partial Response or Stable Disease) in every one of the 13 patients so far enrolled in this study. A study by The National Cancer Institute of Canada demonstrated that patients with advanced NSCLC with Stable Disease as best response for treatment had Overall Survival similar to patients with Partial Response. The relatively long survival times observed in the first cohort of this trial are encouraging and are in agreement with the NCIC observations," said Dr. Igor Sherman, YM's Director of Clinical Research. "Although nimotuzumab specifically targets the EGF receptor, the reported absence of side effects, particularly the absence of severe rash, makes nimotuzumab therapeutically attractive in this setting." The Phase I component enrolled patients at three centers in Canada and is evaluating the safety and feasibility of administrating nimotuzumab at three dose levels (100mg, 200mg and 400mg weekly) with palliative radiation (30 Gy in 10 fractions). The data will be used to select the optimal effective dose for the randomized Phase II component of the study, in which Overall Survival will be the primary endpoint. Of the six patients enrolled in the 1st cohort (100mg), four Partial Response (PR) and two Stable Disease (SD) were reported as at August 14, 2007. Median Overall Survival of the group was 41.5 weeks. All patients ultimately progressed. Two severe adverse events have been reported, neither causally attributable to nimotuzumab. A notable absence of grade III/IV rash or diarrhea in this cohort was reported. Of the seven patients enrolled in the 2nd cohort (200mg) of the study, two PR and five SD were reported as at August 14, 2007 Median overall survival of the group has not been reached but currently exceeds 25 weeks. There has been a notable absence of grade III/IV rash or diarrhea reported in this cohort. Enrollment is now ongoing into the third cohort, to be treated at 400 mg per dose level, and accrual is anticipated to be completed by the end of 2007. YM is conducting the trial in Canada and Kuhnil Pharmaceutical Co. is conducting a parallel trial in Korea with a common protocol. This structure is designed to accelerate overall recruitment and lower the costs to the participants. The interim report from Phase I Korean patients is anticipated early in 2008.

SEOUL, South Korea, Sept. 4 -- While, overall, women with advanced stage lung cancer tend to live longer than men, the same is not true for premenopausal women, researchers found. Non-small-cell lung cancer survival was longest, at 11.6 months, for postmenopausal women, intermediate for men, and shortest, at 7.0 months, for premenopausal women younger than age 45 in pooled analysis of two large trials presented here at the International Association for the Study of Lung Cancer world conference. The female survival advantage appeared to be primarily accounted for by women over age 60, which supports the role of estrogen in lung cancer, reported Heather A. Wakelee, M.D., of Stanford (Calif.) University, and colleagues. "Consistently across stages, across studies, women live longer than men and here we have the younger women . . . doing worse than men," Dr. Wakelee said. "That's something that we really hadn't seen before." "One of the big things that's been coming out in lung cancer is the estrogen story," she said. "At least in the lab it's been shown that estrogen can stimulate lung cancer growth." So, the researchers looked to see if the differences in survival between women and men might be mediated by hormonal status as hypothesized in a prior observational study. They analyzed data for 1,590 non-small-cell lung cancer patients from two Eastern Cooperate Oncology Group (ECOG) trials, excluding those treated with bevacizumab (Avastin) in one of the trials because of confounding factors. There was no difference in prognostic factors across age and gender groups. The majority of participants were men (62%) and at least 60 years old (58.2%). Median survival was significantly shorter among women younger than age 60, which was chosen as a cut-off age for menopausal status, than among older women (9.0 months versus 11.6, P=0.029). For men, there was no significant difference between those younger than 60 or 60 and older (P=0.17). When the researchers further stratified by age to separate out women who were clearly premenopausal, the difference was even more dramatic and showed opposite trends for men and women. The median survival findings were: 7.0 months for women younger than 45, 9.5 months for women 45 to 59, 11.6 months for women 60 or older (P=0.05). 8.7 months for men younger than 45, 8.3 months for men 45 to 59, and 7.4 months for those 60 or older (P=0.022). A significant difference in survival between men and women only at age 60 or after (difference 1.7 months younger than 45, P=0.39; 1.2 months 45 to 59, P=0.059; 4.2 months 60 and older, P<0.0001). Likewise, women younger than 60 had significantly shorter progression-free survival than postmenopausal women (3.8 months versus 4.7, P=0.0095) whereas there was no difference among men (3.4 months versus 4.0, P=0.50). Although there are factors other than hormonal status that could have an impact on the difference in survival between younger and older women, future studies should analyze whether early induction of menopause with chemotherapy is beneficial, Dr. Wakelee said, as some studies have found for breast cancer.

Teri, I'm so glad your first day back at work went well. I hope your next day there is even better.

Jill, my heart is breaking for you. I hope your mom finds comfort soon. Prayers for you and your family.

New research studies at Norwalk Hospital are targeting one of the most difficult types of cancer to treat: lung cancer that has spread to the brain. Lung cancer remains one of the most common and lethal malignant cancers to affect adult men and women. Approximately one-third of newly diagnosed patients will have evidence of spread of the disease to the brain, called brain metastases. Brain metastases are typically treated with surgery and/or radiation, though they are rarely cured by these methods. Chemotherapy drugs may shrink lung cancer that is growing in the body but they are ineffective against cancer growing in the brain. For these reasons, new approaches are needed to treat lung cancer related brain metastases. Significant strides in the treatment of lung and other cancers have resulted from the introduction of “targeted therapies,” medicines that slow cancer growth by binding to one or a few specific molecules in cancer cells. Because they are more targeted than traditional chemotherapy drugs, they tend to cause fewer side effects and can often be combined with chemotherapy for a superior cancer-fighting effect. As part of three new clinical trials at Norwalk Hospital, the targeted therapies Sutent (Pfizer), Avastin (Genentech) and Zactima (Astra Zeneca) are being offered to patients with lung cancer who also have brain metastases. These medicines all target the blood supply of cancer but do so in distinct ways. “These are very important studies for lung cancer patients to be aware of. Aside from surgery and radiation, we have no accepted medicines to treat brain metastases,” said Dr. Richard Frank, director of cancer research at the Whittingham Cancer Center of Norwalk Hospital. “The medicines under study interfere with the blood supply on which all cancers depend; they are called anti-angiogenesis therapies and have had a major impact on the treatment of a variety of cancers. We do not know how effective or safe they will be for lung cancer patients who have brain metastases, so they are only available as part of clinical trials such as these,” he said.

Slick packaging, pretty colors and rosy images reach out to female consumers from the pages of a magazine. Their allure is not unusual for businesses seeking to attract customers. But in this case, the image is a mirage and the purchases could be deadly to any woman who doesn't read between the lines. You see, the product advertised is a brand of cigarettes. From Vogue to Glamour, Cosmopolitan to Elle, their slick approach is deceiving. There's nothing glamorous about lung cancer, a proven consequence of cigarette smoking. Women members of the Indiana Senate, like those in the U.S. Congress, have united to condemn this practice. While cigarette companies are subtle in their approach, they have aggressive intentions. The industry spends an estimated $239 million annually for marketing in Indiana alone. They need to find replacement smokers, because their loyal customers are dying every day. This is especially true in Indiana, which has the second-highest adult smoking rate in the nation. Did you know that 9,700 Hoosiers die from tobacco use each year? Twenty-five percent of Hoosier women smoke; 4,125 die each year. Thirty percent of Hoosier high school girls smoke and nine of 10 begin before age 19. Indiana spends $778.6 million annually for women with smoking-related illness. In addition, Hoosiers pay $13 million in federal taxes each year to cover Indiana's share of Social Security Supplementary Income payments to children who have lost a mother to smoking. Sen. Beverly Gard is a survivor of breast cancer. She can tell you about the physical and emotional tolls cancer brings -- information you won't find in the fancy new magazine ads. It might surprise you to know more Hoosier women die from lung cancer than breast cancer. During this year's legislative session, all women in the Indiana Senate -- Republicans and Democrats alike -- supported the Indiana Check-Up plan, including a component that discourages smoking and offers help to those who want to quit. Now, a bipartisan group of 10 women senators is uniting again, condemning these advertisements and urging Indiana magazines to reject them. According to reports, R.J. Reynolds is spending an estimated $25 million to $50 million on advertising campaigns to introduce its new women's version of Camel No. 9 -- sounding more like a perfume than a cigarette. As everyone knows, smoking cigarettes has the opposite effect of spraying on perfume. It's time we told cigarette companies and the magazines catering to them that the lives of women across this state and nation can't be bought. Colorful packaging can't hide the true darkness of cigarettes.

Science Daily — A common molecular pathway could help physicians predict which lung cancer patients will benefit from chemotherapy drugs, according to new research from a multidisciplinary team at the University of Cincinnati (UC). Michael Reed, MD, and William Zagorski of UC's surgery department study the role of the RB tumor suppressor in lung cancer. (Credit: Image courtesy of University of Cincinnati) Known as the retinoblastoma (RB) tumor suppressor, this fundamental molecule regulates cell proliferation in the body. Research has shown that the RB pathway is either entirely inactive or altered in most human cancers. Scientists are beginning to use its actions as a "biomarker" for how tumors will respond to different therapies. Michael Reed, MD, and his UC colleagues found that "turning off" the RB pathway in lung cancer cells resulted in an altered response to chemotherapy agents and more cancer cell death. They report their findings in the September 2007 issue of the journal Cancer Research. "Dissecting the RB pathway will help us better understand how chemotherapy works and predict which patients might benefit from therapy and which ones won't," explains Reed, assistant professor of surgery at UC and a thoracic surgeon at University Hospital. "As pathways are further defined, we could choose agents that are targeted to an individual tumor's molecular characteristics," he adds. A previous UC study, published in the January 2007 issue of the Journal of Clinical Investigation, showed that when this pathway is disrupted or shut off in breast cancer, the tumor resists anti-estrogen drugs and the cancer continues to grow in spite of the therapy. For this laboratory study, Reed's team shut off the RB pathway in human non-small cell lung cancer cells and exposed them to chemotherapy agents representative of those currently used to treat lung cancer patients. Their results showed that when RB was turned off, the cancer cells continued to divide, but became more susceptible to the drugs, so the tumors stopped growing. "But the minute you take away the chemotherapy, the cells take off again," says Reed. "This suggests that it's not just loss of RB that affects therapy response--it could be changes at various steps in cellular signaling that result in different outcomes." "The traditional way of thinking of cancer--one cancer gene to treat and you're done--is obviously not the best approach to treating this disease," he adds. "These are complex, overlapping molecular pathways. Dissecting them and determining how to use that information to apply combinations of chemotherapeutic agents will allow for individualization of therapy." Next year, Reed and his colleagues expect to begin testing the RB tumor suppressor in human tumor tissue samples from the UC Thoracic Tumor Registry and compare them to patients with known outcomes. According to the American Cancer Society, more than 213,000 Americans will be diagnosed with lung cancer in 2007. Because most people are diagnosed late, the five-year survival rate is only 14 percent--compared with 86 percent for breast cancer, 61 percent for colon cancer and 96 percent for prostate cancer.

An ounce of prevention has always been worth a pound of cure, and when it comes to preventing lung cancer, it could be worth lives. Lung cancer is the number one cause of cancer deaths in the United States As a matter of fact, it is responsible for more deaths than colon, breast and prostate cancers all put together. While smoking is the number one risk factor for someone to develop lung cancer, not all lung cancer patients are smokers and never have been. And quitting smoking will gradually reduce the risk of lung cancer, but much of the damage that has been done by years of smoking is irreversible. Now if there were a way to test who are at high risk for developing lung cancer and look for any genetic changes that occur before the cancer develops, we may be able to prevent a good number of cases each year. Researchers at the University of Colorado are doing just that. A team led by Wilbur A. Franklin, M.D.,is Professor of Pathology at the University of Colorado Health Sciences Center has set out to develop the techniques for screening the lungs for lesions that could indicate pre cancerous genetic changes. Recent discoveries have shown that these genetic changes are not a random occurrence. They are the result of very specific chromosomal instabilities that may be the beginning signs of future cancer One of the other researchers working on the study is Marileila Varella-Garcia, M.D., also of UCHSC/ Dr. Varella- Garcia focused on these chromosomal changes. They had a group of 71 participants, 14 of which had lung cancer, 43 of which were smokers considered to be at high risk for developing lung cancer and 14 of which were healthy and non smokers. They used a method called spectral karyotyping (SKY) to examine the bronchial epithelium in the participants, hoping that they would be able to identify the underlying genetic changes that could be the forerunners of cancer. The researchers did find that there was a significant difference in the chromosomal abnormality index (CAI) of those who never smoked as compared to the index of the smokers and the lung cancer patients. Of the smokers who did not have cancer, 82% had chromosomal abnormalities. Patients with cancer had 23 times more of the chromosomal abnormalities than non smokers and smokers who did not have cancer had 15 times more. In order to confirm the results they got from using the SKY system, they used another technique called fluorescence in situ hybridization (FISH). This one does not have as comprehensive a view of the changes, but it does do something that SKY does not. It can detect changes in interphase cells which are cells that are at the point in their cycle when ir doubles its cytoplasm, the gelatinous, semi-transparent fluid that "fills" most cells, and synthesizes DNA. This is only the first step in the research. It is too early yet to give a definitive yes on whether or not the changes are a true prediction of future cancer, but the data is positive enough to so that further research is planned.

Chronic obstructive pulmonary disease (COPD) in individuals who never smoked is associated with lung cancer-related mortality, according to an analysis of data from the American Cancer Society's Cancer Prevention Study II (CPS-II). A prospective study examining the relationship of emphysema and chronic bronchitis to lung cancer mortality was conducted by Dr. Michelle C. Turner at the University of Ottawa in Ontario, Canada, and associates. The investigators used 20 years of data on 448,600 participants in CPS-II who had never smoked and were cancer-free at baseline. As reported in the August issue of the American Journal of Respiratory and Critical Care Medicine, the hazard ratio for lung cancer mortality was 1.66 for emphysema alone and 2.44 for emphysema plus chronic bronchitis. There was no association between chronic bronchitis alone and lung cancer mortality, although the researchers found a trend in that direction for men. The association between emphysema and lung cancer mortality in never-smokers was stronger in the later years compared with the early years of data. "This large prospective study strengthens the evidence that increased lung cancer risk is associated with nonmalignant pulmonary conditions, especially emphysema, even in lifelong nonsmokers," the investigators conclude. The main limitation of the study, Dr. Turner and colleagues point out, "is that we are unable to distinguish whether COPD is in the causal pathway for lung cancer or whether both COPD and lung cancer are related to an underlying exposure, or some combination of both, with or without inherited familial predisposition."

My deepest sympathies to you and your family.

Health reporters whose work has raised awareness about lung cancer can enter the second annual Lung Cancer Journalism Awards competition. Last day to apply: September 28. Winners receive a EU€7,000 (about US$9,500) research grant. Organized by the Global Lung Cancer Coalition (GLCC), the competition is divided into three categories: Best Medical Article, Best Consumer Article, and Best Broadcast Article. Entries must have been published or broadcast sometime from September 1, 2006, to September 1, 2007. More details and application forms are available at http://www.lungcancerjournalism.com. For other queries, contact info@lungcancerjournalism.com

Science Daily — A new technique could pave the way toward screening people at risk for lung cancer for the genetic changes that may foreshadow malignancies, researchers from the University of Colorado say. "The most successful way to reduce mortality in cancer is prevention," said researcher Wilbur A. Franklin, M.D., Professor of Pathology at the University of Colorado Health Sciences Center. "Our goal would be to develop screening techniques for lung lesions that could enable us to identify precancerous changes." Lung cancer is the leading cause of cancer deaths in the U.S., and kills more people than the next three most common cancers--colon, breast and prostate--combined. While it is well-established that smoking is the primary risk factor for lung cancer, a number of lung cancer patients have never smoked. Additionally, quitting smoking only gradually reduces the risk of lung cancer because much of the genetic damage done by tobacco is irreversible. Recent research suggests that the genetic changes that accompany lung cancer are not random, but are associated with specific chromosomal instabilities that may be indicative of future carcinomas. Researcher Marileila Varella-Garcia, M.D., also of UCHSC, targeted these non-random chromosomal changes in the study. The investigators used a technique called spectral karyotyping (SKY) to examine the bronchial epithelium (BE) of 71 subjects--14 patients with lung cancer, 43 smokers at high risk for developing lung cancer and 14 healthy non-smokers--in the hope of identifying underlying genetic changes that might be hallmarks for cancer. "It is critically important that we thoroughly understand the nature and timing of the cellular and genetic effects of tobacco smoke on BE in order to identify biomarkers and devise intervention strategies that might reduce the persisting morbidity and mortality from lung cancer," said Dr. Varella-Garcia. The researchers found a marked difference between the chromosomal abnormality index (CAI) of never-smokers and that of high-risk smokers and patients with lung cancer. "There's a tremendous amount of chromosomal damage in smokers who don't yet have cancer," said Dr. Franklin. "Chromosomal abnormalities were observed in 82 percent of high-risk smokers and in all patients with carcinoma, regardless of their self-reported tobacco exposure." Patients with cancer and high-risk smokers had nearly 23 and 15 times more chromosomal abnormalities, respectively, than never-smokers. The most common changes among patients with cancer and high-risk smokers were gains on chromosomes 5, 7, 8 and 18. The results from SKY were confirmed by fluorescence in situ hybridization (FISH). The FISH technique offers a less comprehensive view of genetic changes, but unlike SKY, can detect genetic changes in interphase cells, which are readily available in sputum samples. "Whereas SKY is not a practical tool to directly apply to sputum, it does identify candidate chromosomal sequences that could improve the sensitivity of a FISH probe set for sputum screening and risk assessment," wrote Dr. Franklin. "Improvement in sensitivity and perhaps automated processing and analysis could move a FISH-based assay toward clinical application." The researchers noted that their pilot study could not affirmatively determine whether the changes were predictive of eventual cancer, but their data point to an important avenue for future research. "It will be necessary to study larger cohorts for a longer interval," they wrote, concluding, "SKY FISH is a feasible technique for comprehensive evaluation of the chromosomal changes in nonmalignant bronchial epithelial cells of high-risk individuals." The study appears in the September 1, 2007 issue of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society. Note: This story has been adapted from a news release issued by American Thoracic Society

Micromet is sticking to its research into cell adhesion antibodies to treat breast cancer and other tumours, hoping it will have more luck than GlaxoSmithKline and Centocor's failed attempt. Epithelial cell adhesion molecule (EpCAM) is over expressed in several types of cancer, including breast, colon and gastric cancers. Although several companies are reported to have developed antibodies against this transmembrane protein, only GSK and Centocor have taken a drug to market: Panorex (edrecolomab). In fact, when Panorex, a murine-based monoclonal antibody (mAb), was approved by German regulators back in 1995, it became the world's first anticancer mAb. However, the initial excitement didn't last and the drug was subsequently withdrawn due to lack of efficacy. Dr Tobias Raum, who heads up lead discovery of antibodies for Micromet, believes this was because Panorex was a murine-based mAb, and so lost its efficacy quickly as it was broken down by human antibodies. He explained that Micromet's own drug, called adecatumumab (MT201), is a human antibody and so is "likely to be much more efficacious and non-immo-toxic." He was speaking at the recent drug Discovery and Development of innovative Therapeutics conference in Boston, US, and took the opportunity to explain to delegates that this explains why the drug actually works better in vitro than Panorex, although both have a similar, intermediate, affinity to EpCAM. This middling binding to its target ensures adecatumumab has a good safety profile, he explained. At first, the company developed a type I immunoglobulin (IgG1), the most abundant subclass of antibodies. However, its scientists soon discovered an IgG2a version worked much better and in a lung cancer model, the number of tumours was almost reduced to zero. A subsequent Phase I clinical trial showed no grade four toxicities, no dose dependence of clearance, and perhaps most importantly, no human antibodies were found against the drug. Micromet then moved it into a Phase II trial in metastatic breast cancer patients. The study had four arms with high and low doses and high and low doses of EpCAM expression. For ethical reasons, no control group was used, explained Raum. However, no overall effective tumour response was observed, which was the primary endpoint of the trial. Despite this, there was some encouraging news for Micromet: in EpCAM positive patients, the time to disease progression was significantly longer in patients treated with the higher dose of the drug. "The finding of better clinical outcome in patients with truly high EpCAM expressing tumours confirms the targeted nature of adecatumumab," said Dr Ahmad Awada, Head of the Medical Oncology Clinic at Institute Jules Bordet in Brussels, Belgium. "[it] is in line with observations from other tumour-specific monoclonal antibodies in oncology like [Roche & Genentech's] Herceptin [trastuzumab]." Raum said that a Phase IIb trial of the mAb in combination with chemotherapy (docetaxel) is currently ongoing.

I started my family leave at diagnosis. The main reason for this was to immediately protect my job. Not knowing what was down the road with my mother's treatment, this gave me peace of mind. Also, it wasn't necessary for me to take the full 3-months in one stretch. I took it as needed, in increments. A half-day here, a full-day there. This worked best for me personally, as I wasn't torn between work and family. I was able to manage both concurrently. Also, during the two years I never came close to exhausting my FL time. My father was just diagnosed in July, had his first chemo treatment on Monday and he is doing just fine right now, but I'm already back on leave.