The Industry Insider: April 2007

By Prachi Patel-Predd and John D. Zoidis, MD
Published: Friday, Aug 13, 2010
THE INDUSTRY INSIDER

%u25BA AVAX and CTCA Collaborating for Cancer Therapies

AVAX Technologies, Inc., a developer of therapeutic cancer vaccines located in Philadelphia, PA, and Cancer Treatment Centers of America, Inc. (CTCA), a network of cancer treatment hospitals and facilities, are collaborating for the benefit of both parties’ cancer therapeutic products. The agreement will advance AVAX’s OVax ovarian cancer vaccine by facilitating a study at CTCA’s centers. At the same time, AVAX will produce CTCA’s activated natural killer cell technology for the treatment of various cancers.

The terms of the collaboration are for a three-year period, during which CTCA will provide AVAX with a funding of $1.15 billion for research and development. CTCA will fund the initial production of vaccines, and for AVAX’s clean room facility, where the company will produce its vaccines as well as CTCA’s natural killer cell preparations.

AVAX plans to activate a phase I/II IND for the treatment of stage III and IV ovarian cancer patients who have relapsed after chemotherapy. The study will evaluate patients for safety and immunological responses. It will be based at CTCA’s hospital in Zion, IL, where CTCA expects to start treating patients this summer.

The new O-Vax vaccine looks promising because it is based on the same technology as AVAX’s metastatic melanoma vaccine M-Vax, which has already been launched commercially in Switzerland and has the US FDA’s orphan drug designation. The technology, called haptenization, works by attaching a chemical hapten to tumor antigens, making it easier for the immune system to recognize the tumors. The safety and efficacy of M-Vax has been evaluated in more than 400 patients with stage III and IV melanoma, and the vaccine has been shown to increase five-year overall survival in patients with stage III melanoma. The newer O-Vax product has also seen good news recently—two phase I/II trials for the O-Vax product have provided  encouraging results showing that the vaccine may prove effective in chemotherapy-resistant ovarian cancer.

“To win the fight against cancer, it is absolutely vital we do everything we can to make innovative new treatments like this available to patients as soon as possible,” said Edgar Staren, chief medical officer of CTCA. “It’s inconceivable that treatments like these that  give hope to patients are often lefton the laboratory bench, while cancer patients are told there is nothing more that can be done for them.”

                                                                                                                                                                                              —Prachi Petal-Predd





%u25BA Full Speed Ahead for GPC Biotech's Satraplatin

After recently announcing positive results from a phase III registrational trial evaluating satraplatin against hormone refractory prostate cancer, biopharmaceutical company GPC Biotech AG has launched an expanded access program for the drug. The results of the trial showed that satraplatin significantly reduces the risk of disease progression in patients.

GPC Biotech, which is headquartered in Frankfurt, Germany, is expecting overall survival data later this year, but the company is moving forward with marketing approval applications. It has already filed the New Drug Application for satraplatin with the US FDA and expects to file an application in the EU by the end of the second quarter.

“Moving forward, we plan to work closely with the FDA regarding our application for marketing approval of satraplatin in the US,” said Bernd R. Seizinger, MD, PhD, chief  executive officer of GPC Biotech. “We also are continuing to aggressively build our marketing and sales organization in the US to prepare for a potential launch of satraplatin later this year.”


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