MsC1210

Hello Theresa Just wanted to say hello and welcome you to this wonderful site. Please feel free to ask any and all questions you have and know that someone here will no doubt be along to help you out. You, your mom and your family are in my prayers, Chris

Takeda And BioNumerik Announce Results Of Tavocept Phase III Trials Focused On Neuropathy Indication 01 Aug 2006 Takeda Pharmaceutical Company Limited ("Takeda," Osaka, Japan) and BioNumerik Pharmaceuticals, Inc. ("BioNumerik", San Antonio, Texas) today announced the results of two Phase III Trials for Tavocept. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik. The initial development focus for Tavocept has been as an investigational new drug to prevent or mitigate the peripheral nerve damage, or neuropathy, that is known to be associated with certain commonly used classes of chemotherapy drugs, such as taxane and platinum agents. Data was recently unblinded by BioNumerik from two placebo controlled Tavocept Phase III clinical trials consisting of (1) a Phase III trial of weekly administration of paclitaxel (a widely used taxane drug) to patients with metastatic breast cancer enrolled from the United States, Russia, and Ukraine (the "Weekly Paclitaxel Breast Cancer Trial"); and (2) a Phase III trial involving administration of paclitaxel and cisplatin (a widely used platinum drug) every 3 weeks to patients with non-small cell lung cancer from Eastern and Western Europe (the "European Lung Cancer Trial"). Both of these trials were aimed at evaluating Tavocept's potential for a neuropathy related treatment indication. Each of the Phase III trials was designed as a randomized double-blind placebo controlled trial with each patient to be randomly assigned to receive either Tavocept or placebo in conjunction with chemotherapy. The primary endpoints for the Weekly Paclitaxel Breast Cancer Trial and the European Lung Cancer Trial were: (1) the total incidence of severe neuropathy caused by the administration of chemotherapy in combination with Tavocept or placebo; and (2) the difference in rates of tumor shrinkage in patients receiving chemotherapy in combination with Tavocept or placebo, in order to determine whether Tavocept has an impact on the anti-tumor effect of chemotherapy. Based on review and analysis of the results, the trials did not meet their primary endpoints and they were inconclusive in terms of demonstrating a statistically significant effect of Tavocept in reducing the incidence of severe neuropathy caused by the administration of paclitaxel and/or cisplatin. In addition, neither of the trials demonstrated a statistically significant finding in terms of objective tumor response rate or tumor protection as assessed in accordance with the predefined statistical analysis plans for the trials, or by an independent radiological review committee. In commenting on the data, Frederick H. Hausheer, M.D., Chairman and Chief Executive Officer of BioNumerik stated, "Many patients suffer from chemotherapy induced neuropathy and there is no FDA-approved treatment to prevent or reduce neuropathy caused by taxane and platinum chemotherapy drugs. Although we did not see the results that we hoped to observe in these Phase III trials, we believe there is evidence of potential clinical activity of Tavocept that supports consideration of possible further Tavocept development aimed at addressing the large unmet medical need for neuroprotective agents. Certain trends and subgroup analyses for the trials indicate that Tavocept may have potential for reducing chemotherapy-induced neuropathy that merits consideration of further clinical testing. In addition, the way that neuropathy was measured and the countries where the trials were conducted may also have impacted the results." Subgroup analysis by country from the Weekly Paclitaxel Breast Cancer Trial revealed a notable finding in favor of Tavocept in the reduction of patient-reported severe neuropathy (as measured by Patient Neurotoxicity Questionnaire (PNQ) grades D or E) for patients enrolled only from U.S. sites. In this subpopulation comprising patients enrolled only from U.S. sites, the incidence of patient-reported severe neuropathy confirmed for at least 4 weeks (PNQ grades D or E) was 3.2% in the Tavocept group as compared to 20.0% in the placebo group. This observation represents an 84% lower incidence of severe neuropathy in favor of Tavocept. The Patient Neurotoxicity Questionnaire (or PNQ) is a patient-based neuropathy measurement tool that was used to measure neuropathy in the Tavocept Phase III trials. The National Cancer Institute Common Toxicity Criteria ("NCI-CTC"), a physician-based neuropathy measurement tool, showed a consistent trend with that of the PNQ in terms of comparing the overall severe neuropathy reported in the Tavocept and placebo arms for patients from U.S. sites in the Weekly Paclitaxel Breast Cancer Trial. However, it is also important to note that only about 8% of the total number of patients treated in the Weekly Paclitaxel Breast Cancer Trial were treated at U.S. clinical sites. "An important factor supporting possible future Tavocept development for a neuropathy indication is the subgroup analysis for patients enrolled only at clinical sites located in the United States who participated in the Weekly Paclitaxel Breast Cancer Trial," said Hausheer. "We also observed some encouraging trends in the Weekly Paclitaxel Breast Cancer Trial that indicate potential activity of Tavocept in reducing moderate to severe neuropathy. These are some of the first Phase III trials conducted to assess the potential reduction of chemotherapy induced neuropathy. We believe there may be modifications in the trial endpoints in the future as well as changes in the procedures for assessing neuropathy in order to clinically assess patients at risk for this complication and to address some of the technical challenges we have observed in these trials to date. While we are encouraged by some of the observations in these trials, it is clear that additional clinical testing will be required to support development of Tavocept for a neuropathy indication." Takeda has notified BioNumerik that, given the additional time necessary to conduct additional clinical testing for a Tavocept neuropathy indication, one possible alternative is termination of the existing Tavocept License and Development Alliance Agreement between Takeda and BioNumerik for the United States and Canada. Takeda and BioNumerik are continuing to discuss the data from the trials as well as considerations regarding the alliance agreement and the future development of Tavocept. About Tavocept: Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik. Tavocept has potential applicability in multiple therapeutic areas including diabetic neuropathy, protection against toxicity from radiation therapy, lymphedema and other potential medical indications. In addition to chemotherapy induced neuropathy, BioNumerik is evaluating further Tavocept development possibilities in these areas. About Takeda: Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, http://www.takeda.com/index-e.html. About BioNumerik: BioNumerik, headquartered in San Antonio, Texas, is a pharmaceutical company focused on the discovery, development and commercialization of novel drugs for the treatment of patients with cancer. BioNumerik has two drug candidates in late-stage clinical development: Tavocept and Karenitecin (BNP1350). BioNumerik Pharmaceuticals; Takeda Pharmaceutical Company http://www.takeda.com/index-e.html Article URL: http://www.medicalnewstoday.com/medical ... wsid=48391

Betty I cannot really comment on the shortness of breath, but I do want say..... HAPPY BIRTHDAY AND BEST WISHES FOR MANY, MANY MORE!!! Chris

Michele My sincere condolences and sympathies on your loss. Chris

Kim, I am so sorry about everything your poor mom has been through, as well as the emotional stress you are under. Sending prayers for strength your way along with tons of positive thoughts. And remember, we are here when you need us. Chris

Hello Although I cannot add anything to what the others before me have said so well here, I did want to welcome you to this site. Please keep us posted on you and your mom and let us know how we can help. Chris

Hello Jan and welcome I am sorry about your dad's diagnosis, but glad you have found this site. Sending best wishes to you, Chris

Hello Brandie and welcome I am sorry you had reason to find this site, but I am glad you did. As you can see there are a lot of great people here to help you out along the way. You have gotten a lot of great advice already here and I cannot add much to that. 2nd and even 3rd or more opinions are so important and I am glad to see you are pursuing that. One thing I will add here. If you have not already done so, pick up a small notebook or organizer to keep notes in regarding the appts and treatments etc that your mom will be going to. Also jot down any questions the 2 of you may have as once you get to the actual appt it is so easy to forget! Ask for copies of the test results for your and moms records. That way you have easy access to them should you decide on another opinion.. Sending prayers and positive thoughts to you and your mom, Chris

Hi Rich Adding my prayers and positive thoughts to the rest! Love that attitude~ Chris

(((Denise))) I am so sorry. I do understand. Happy Birthday to Dominick. Chris

Lori I cannot add more to what the others have already said here. I can, however, send you tons of prayers for strength and courage and I am doing that. I am happy to hear your mom is doing well. hugs, Chris

Prayers and condolences to you and your family. I am so sorry for your loss. Chris

More prayers for both and for you as well Welthy, what a wonderful friend you are. Chris

Mary, In the General forum there is a sticky post, "LCSC Dictionary". You will find a lot of the common abbreviations listed in the thread there. Chris

Hello Mary, SOB means short of breath. I think there is a post somewhere that has a list of the common abbreviations. I will see if I can locate it and send you in that direction. Chris

This is not entirely lung cancer related, but interesting none the less.. From this mornings Calgary Sun... July 26, 2006 Heat cranked to kill cancer Scientists hope hot concept leads to treatment progress By CP TORONTO -- It's a concept that's been used since the time of Hippocrates -- using heat to treat what ails us. Now, U.S. researchers want to apply that age-old therapy to try to kill certain cancer cells, and they're using the experience of modern-day sports hero Lance Armstrong and others cured of advanced testicular cancer as the underpinning for their investigations. In a commentary in today's Journal of the American Medical Association, researchers from Johns Hopkins University say the reason advanced testicular cancer has such a high cure rate -- 80% or more -- is because the tumour cells are sensitive to heat. And they suggest that makes these cells easier to kill with chemotherapy and radiation, even when they have spread to form tumours in other parts of the body. That's because cells in the testicles -- whether healthy or malignant -- start out a few degrees lower than body temperature (37C), part of a built-in system aimed at keeping heat-sensitive sperm cool and safe. (It's why men with fertility problems are advised to wear loose boxer shorts instead of tight, heat-retaining briefs.) So when cancer cells spread beyond the testicle, they end up in a much warmer environment, said co-author Robert Getzenberg, director of urology research at Johns Hopkins in Baltimore, explaining the excess heat appears to weaken the cells' inner structure, making them easier to destroy with drugs and radiation. The researchers plan to test this principle, dubbed the Lance Armstrong Effect, on other types of metastasizing cancers, Getzenberg said yesterday. "There are some differences that exist, obviously, between testicular cancer cells and breast cancer cells, but our feeling is that the general principle will be the same, that the temperature differences that go on when a cell metastasizes will make it more susceptible," he said. The researchers point out that warming up the body has been used since ancient times as a treatment for ailments ranging from back pain to arthritis. It's a simple notion, but one they hope fellow scientists will start investigating for possible application to one of medicine's most complex diseases.

Hi Shirley This seeding is all so new to me but I am very interested to find out how it goes. Please keep us all posted and of course prayers are going out and up for proper placement! I am going to do some reading about this procedure today so I can get caught up on this and be more able to help you out along this latest avenue. Chris

Hello Angela, I cannot offer much in the way of advice but wanted to say hello and welcome. Chris

Congratulations. I hope you have many, many more. Chris

Ellen Fingers crossed for you here, too. Keep us posted... Chris

Hiya Shirley Well it was not the driest of weekends here but it was not a complete loss, either. No complaints! Hoping the crown goes well and is over and done quickly. Praying for a quick appt for the cyberknife~ Keep us posted! And, hope brunch is great. I am sure it will be, and the company could not be better, eh? lol Hi to Steve and hopefully we can catch up soon. I think I am around this evening so I will look for you then. Hugs Chris

Hello Patches and welcome. I am sorry you have need to be here but am very glad you have joined us. This is the most wonderful site, full of great people who can and will answer your questions and sometimes even more importantly, we are here to help you and support you in this battle. Congrats on quitting smoking! I personally know how difficult that is. Let us know how we can help you and keep us posted. Sending loads of positive thoughts your way, Chris

Lisa What wonderful news! Praying the remaining chemo goes smoothly with few side effects and that your dad enjoys continued success in his fight~ Chris

Hello and Welcome to the site, You sound like a true fighter! You will find tons of support here to help you continue that fight. Chris

This is good news. Keep us posted and you all remain in my prayers, Chris