Pharmacotherapy
Tarvacin Plus Docetaxel Significantly Inhibits Breast Tumor Growth
By Peregrine Pharmaceuticals
May 27, 2005 - 6:03:00 PM

Peregrine Pharmaceuticals, Inc. , today announced that a research article titled "A Monoclonal Antibody that Binds Anionic Phospholipids on Tumor Blood Vessels Enhances the Antitumor Effect of Docetaxel on Human Breast Tumors in Mice" was published in the May 15 issue of Cancer Research.

The published report shows that 3G4 (a murine equivalent of the company's Tarvacin(TM) monoclonal antibody) in combination with docetaxel results in a 93% inhibition of human breast cancer growth in mouse models.

The researchers found that docetaxel increases the exposure of the 3G4 target on tumor blood vessels but not healthy tissue. Patient enrollment in a Tarvacin(TM) Phase 1 clinical trial for the treatment of all solid tumors, including breast cancer, is expected to commence this month at three clinical sites.

"Our results suggest that Tarvacin(TM) holds promise to be a therapeutic agent that can significantly improve current breast cancer therapy," said Dr. Xianming Huang, the lead author of the report. "While docetaxel is the most important cytotoxic drug currently available for breast cancer, its maximum dose is limited by its toxicity, leaving a pressing need for combination therapies that improve its efficacy without exacerbating its toxicity."

Dr. Huang is an assistant professor of pharmacology in Dr. Philip Thorpe's laboratory at the University of Texas Southwestern Medical Center at Dallas. Further pre-clinical studies studying the potential of Tarvacin(TM) in the treatment of drug-resistant breast cancer and in breast cancer metastasis are ongoing at UT Southwestern under a grant by the Susan G. Komen Breast Cancer Foundation and a sponsored research agreement with Peregrine Pharmaceuticals.

In the study, treatment of mice with 3G4 plus docetaxel inhibited tumor growth by 93% as compared with 50% and 70% for 3G4 and docetaxel, respectively, when used as single agents. Furthermore, treatment of mice bearing disseminated breast cancer with the same combination reduced the average number of tumor colonies in the lungs by 93% and half of the animals did not develop tumors at all. Docetaxel and 3G4 inhibited lung colonization by 78% and 82% respectively when given as single agents. In both models, the combination therapy was no more toxic to the mice than docetaxel alone.

About Tarvacin(TM)

Tarvacin(TM) is part of Peregrine Pharmaceutical's Anti-Phospholipid Therapy platform, which binds directly to tumor blood vessels to inhibit tumor growth and development. Tarvacin(TM) is a chimeric monoclonal antibody that binds to the phospholipid, phosphatidylserine. Tarvacin(TM) was initially discovered by researchers at UT Southwestern Medical Center at Dallas, who have worked closely with Peregrine to explore the potential activity and safety of Tarvacin(TM) as a treatment for cancer. Peregrine has a sponsored research agreement with researchers at UT Southwestern to study the use of Tarvacin(TM) and its parent antibody for the treatment of cancer and viral diseases.

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