New Drugs ASCO

[Cary]

This is an article of current drugs in the pipeline that hold some promise for the treatment of Lung Cancer.

Cary

Several new drugs that take specific aim at cancer cells are showing early promise in small clinical trials, although the results are preliminary and offer no guarantee that the drugs will ever reach the market.

Unlike ordinary chemotherapy, which kills many healthy cells as well as tumor cells, these new drugs are designed to defuse tumors directly without harming other tissue. Few of these drugs, however, have yet been tested in the most rigorous way possible, involving large trials of hundreds of patients who are randomly assigned to receive either the drug or a placebo.

That said, these midstage "phase II" trials can provide early hints as to whether a drug works or not, helping companies decide whether to spend millions of dollars on larger phase III tests that can take years to complete. The results were reported at the annual meeting of the American Society of Clinical Oncology in Chicago.

Telik Inc., Palo Alto, Calif., said preliminary data on its experimental drug Telcyta showed that it shrank tumors in three of 20 advanced breast cancer patients and at least stabilized tumor growth in a total of seven patients.

Telcyta is a small molecule "prodrug" that is cut into toxic pieces by an enzyme generally present only in cancer cells. Telik has also tested the drug in ovarian, colon and lung cancer. A phase III trial of the drug is already under way, and the company is preparing to launch a similar large trial in lung cancer as well.

Seattle Genetics Inc. said its experimental drug SGN 15 appeared to slow the progress of lung cancer tumors in preliminary results from 62 patients. The Seattle based company's drug, which combines a traditional chemotherapy drug with an antibody designed to stick to the surface of cancer cells, aims to carry the toxic drug directly to tumors, concentrating its killing power.

When tested in combination with Taxotere, a traditional chemotherapy agent, SGN 15 appeared to stall cancer for an average of 15.3 weeks as opposed to 7.4 weeks in patients who received only chemotherapy.

In a presentation over the weekend, Amgen Inc. and Abgenix Inc. said their experimental drug ABX EGF showed some ability to control colon cancer. At the end of eight weeks of treatment, four of 40 patients saw their tumors shrink by at least half, and cancer had stabilized in a total of 22 patients.

ABX EGF targets a growth related protein on the surface of cancer cells, much like Iressa from AstraZeneca PLC and Erbitux from ImClone Systems Inc.

Genentech Inc. and OSI Pharmaceuticals Inc. said their own drug in that class, Tarceva, showed very early promise in treating brain cancer, which is difficult to treat with drugs. In a phase I trial of 49 patients, eight saw their tumors shrink by half or more.

In separate news, Amgen reported over the weekend that its experimental drug Palifermin reduces the likelihood of oral mucositis, or severe mouth ulcerations, in chemotherapy patients.

See some of the cancer treatments in the pipeline:

Drug Type of Cancer Company Status

ABX-EGF lung, colorectal Abgenix Trials are ongoing. Interim Phase II results in May 2003 indicated promise as an antitumor drug.

Arimdex breast AstraZeneca Received FDA approval March 2002

Avastin colon, breast, lung Genentech Study presented June 1, 2003 showed 45% of patients saw tumors shrink by at least half when used with chemotherapy.

Eloxatin colon, rectum Sanofi-Synthelabo Received FDA approval August 2002.

Erbitux head and neck, lung, colorectal ImClone ImClone got a boost after clinical trial results presented this weekend confirm exciting results of two years ago.

Faslodex breast IPR Received FDA approval April 2002.

Gleevec leukemia Novartis Received FDA approval February 2002.

Iressa lung AstraZeneca Is FDA approved to treat advanced lung cancer in some patients, but recent trial data show promise for treating other cancers, including brain, colorectal, breast, and head and neck.

Velcade multiple myeloma Millennium Pharmaceuticals Approved May 2003

Neovastat kidney, lung Aeterna Laboratories Undergoing widespread human testing, a final phase before application for regulatory approval.

SU11248 leukemia Pharmacia/Sugen Early stage testing.

SU5416 colorectal Pharmacia/Sugen Pharmacia halted late-stage clinical trials on the much-hyped cancer medicine after investigators found the drug, which is similar to Avastin, to be ineffective in extending survival rates for late-stage cancer patients.

Tarceva lung, pancreatic OSI Pharmaceuticals Is being tested in clinical trials, including a combined treatment with Avastin.

Xyotax lung, ovarian Cell Therapeutics Is in late stage clinical trials.

Zamyl leukemia Protein Design Labs Was shown to be of limited usefulness in a large study of 191 patients. The company is convinced Zamyl has "possible therapeutic activity," and said it will seek out partners to continue the drug's development.

Zometa prostate, bone Novartis Received FDA approval February 2002 for new application. A later study showed Zometa to be an effective treatment of bone complications related to prostate cancer.