Results of XL765 Clinical Trial Expected on January 31 (NASDAQ:EXEL)

On June 1, 2009, Exelixis, Inc. (NASDAQ:EXEL) announced that they received favorable results from the Phase 1 trial of XL765. The trial dealt with finding the effects of increasing the dose of XL765. XL765 is an innovative drug that is being co-developed by Exelixis Inc. and Sanofi Aventis.  This drug aims to treat patients who have solid tumors. It works by preventing the actions of PI36 and mTOR, which are kinases that result in the growth of tumor cells. Moreover, these kinases make the tumor cells resistant to treatments like radiotherapy and chemotherapy. On October 28, 2009, Exelixis announced that the company was carrying out another trial to find the efficacy of XL765 when used in combination with Tarceva (Erlotinib). The company expects to disclose the results of this trial by January 31, 2010.

@@CalendarRight@@ The companies’ stockholders hope that the results of this trial would be just as favorable as that of the previous one. Earlier, Patricia LoRusso, DO, who is the Medical Director of Phase I Clinical Trials at Karmanos Cancer Institute, had been analyzing the Phase 1 trial of XL65. On June 1, 2009, she presented the results from the Phase 1 trial at the American Society of Clinical Oncology Annual Meeting, which took place in Orlando.

Michael M. Morrissey, Ph.D., who is the President of the R&D department of Exelixis, said:

“The data from this trial demonstrate that XL765 is a potent inhibitor of PI3K and mTOR that provides robust PI3K pathway inhibition in tumors at well-tolerated doses. We are encouraged by these preliminary results and the finding that a number of patients remained on study without disease progression for more than 16 weeks, with one patient on study more than 41 weeks. The pharmacodynamic effects observed across diverse tumor types suggest that XL765 may have utility in a variety of cancers.”

@@AdsenseLeft@@ In the trial, participants were given once or twice doses of XL765 every day. There were a few cases of dangerous side effects from the use of XL765, like colon cancer and rectal cancer. These occurred when the tumors underwent mutations, which were caused by XL765. Other less serious effects included weakness, anorexia (lack of appetite), vomiting, nausea, vomiting and transaminase disease.

The trial found out that the maximum tolerated dose (MTD) of XL765, if administered twice every day, was 50 mg. In addition, it showed that increasing the dose of XL765 would lead to higher concentration of the drug in the cells, and would tumor cells more exposed to this drug.

Exelixis, Inc. is a “development-stage biotechnology” company, which discovers and develops innovative small molecule drugs for many life threatening diseases, though its main focus is always on cancer. Many of its well known drugs, such as XL765, are in the Phase 1, phase 2, and Phase 1 of clinical development. Previously, it had formed “strategic corporate alliances” with some of the world’s largest pharmaceutical companies, like GlaxoSmithKline, Boehringer Ingelheim, Genentech, and Bristol-Myers Squibb. In 2009, the company announced that it has formed a strategic corporate alliance with Sanofi-Aventis. Under the Global License Agreement, both companies would work together to co-develop the novel XL765.