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Biopharmaceuticals Oncology

 News Release - October 3, 2006

Plexxikon Files IND Application for Targeted Cancer Therapeutic PLX4032

Leading Oncologist Dr. George Demetri Joins Scientific Advisory Board

BERKELEY, Calif.--(HSMN NewsFeed)--Plexxikon Inc. today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead oncology compound, PLX4032. This targeted anticancer agent selectively inhibits the cancer-causing BRAF(V600E) gene found in subsets of different cancers, including 70% of malignant melanomas and a significant number of colorectal and thyroid tumors. The company will use a new test to detect the presence of this cancer-causing gene to identify patients most likely to respond to PLX4032, enabling an exquisitely personalized medicine.

"PLX4032 blocks one of the most common genetic mutations known to cause cancer, and has the potential to become a first-in-class oral therapeutic for the treatment of advanced skin cancer," said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon Inc. "Initially, we will develop PLX4032 for advanced melanoma, followed by colorectal and potentially other cancers in the future. With this compound entering clinical development, we have a broad portfolio of clinical and preclinical stage assets in metabolic disease, cardiovascular disease, inflammation and oncology -- all generated by our robust drug discovery platform."

Preclinical studies in both melanoma and colorectal cancer models demonstrate that PLX4032 reduces tumor size or slows the progression of tumors for extended periods, even after the completion of treatment. Highly selective against B-Raf(V600E) compared to a panel of over 70 other kinases, PLX4032 works specifically on cancer cells, leaving healthy cells untouched. Thus, PLX4032 has demonstrated a very favorable side effect profile, and should be able to be used safely in combination with other anticancer drugs. Pending activation of the IND by the FDA, Plexxikon intends to initiate Phase 1 dose escalation studies in cancer patients by the end of this year.

Plexxikon is collaborating with Roche Molecular Systems, Inc. to develop an in vitro assay to screen for the presence of the BRAF(V600E) mutation in patients' tumors. Using a diagnostic test to correlate the presence of this genetic mutation with clinical outcome may potentially expedite clinical development of PLX4032.

About PLX4032

PLX4032 is a selective inhibitor of the activated BRAF(V600E) gene found in 70% of malignant melanomas and a significant percentage of other cancers. The Wellcome Trust Sanger Institute estimates that 100,000 cancer patients in the United States have tumors bearing the BRAF(V600E) oncogene. This mutation is often correlated with decreased patient survival. Compounds like PLX4032 that target activated kinases have shown significant efficacy in the treatment of cancers, as in the case of Gleevec® (imatinib) in CML patients and Tarceva® (erlotinib) in non-small lung cancer patients.

George Demetri, M.D. of Dana-Farber Cancer Institute Joins Plexxikon Scientific Advisory Board

Today, Plexxikon also announced the appointment of George Demetri, M.D., a leading oncologist, to the company's scientific advisory board. Dr. Demetri is the director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School, a director of the Ludwig Institute for Cancer Research, and an associate professor of medicine at Harvard Medical School. His research and clinical interests are in the area of translational applications of signal transduction, and agents that are involved in the inhibition of malignant cells. Dr. Demetri has served as the principal investigator for several human clinical trials of novel anti-cancer agents, including Sutent®.

"Dr. Demetri's wealth of experience in cancer research and development complements our internal oncology team at Plexxikon, who have worked diligently to move PLX4032 into development," stated Dr. Hirth. "His commitment to finding new alternatives to treat cancer and increase patient's quality of life will play an integral role in our future development of this unique anticancer compound."

Plexxikon Profile

Plexxikon is a leader in the discovery and development of novel small molecule pharmaceuticals to treat human disease. Plexxikon's proprietary Scaffold-Based Drug Discovery(TM) platform is being applied to build therapeutic franchises in metabolic and cardiovascular disease, inflammation and oncology. This discovery process integrates a number of state-of-the-art technologies, including structural screening as one key component that provides a significant competitive advantage over other drug discovery approaches. To date, the company is advancing a portfolio of clinical and preclinical stage compounds in each of these franchises.

Currently, the company's most advanced program is a PPAR pan-agonist for the treatment of diabetes and related cardiovascular complications, with the lead candidate now in Phase 2 clinical testing in collaboration with Wyeth Pharmaceuticals. Other discovery programs include a dual kinase inhibitor for the treatment of rheumatoid arthritis and other inflammatory diseases, and a renin inhibitor for hypertension in collaboration with Servier. Plexxikon is seeking pharmaceutical and biotechnology partners for select collaboration opportunities. For more information, please visit

Source: Plexxikon

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