Healthcare Industry News: skin cancer
News Release - March 27, 2007
Myriad Genetics Initiates Phase 2 Clinical Trial of Azixa in Metastatic Brain CancerSALT LAKE CITY, UT--(Healthcare Sales & Marketing Network)--Mar 27, 2007 -- Myriad Genetics, Inc. (NasdaqGS:MYGN ) (www.myriad.com) announced today that it has initiated a Phase 2 human clinical trial of its therapeutic candidate, Azixa(TM) (MPC-6827), in patients with melanoma that has spread to the brain.
The Phase 2 trial is designed to determine the safety profile of Azixa and the extent of its ability to improve the overall survival of patients with melanoma skin cancer with brain metastases. The trial will compare the survival of patients treated with Azixa to those treated with temozolomide or the combination of Azixa plus temozolomide.
The trial is designed as an adaptive, open label, multiple dose study in patients with metastatic melanoma. The first stage of the trial is designed to determine the safety and the maximum tolerated dose of Azixa in combination with temozolomide. The format for stage 1 is a six patient cohort, given daily temozolomide and weekly Azixa for six weeks. The maximum tolerated dose of Azixa alone was determined during the earlier Phase 1 trials. The second stage of the trial will then assess the overall survival of patients treated with Azixa alone, compared to temozolomide alone or the Azixa/temozolomide combination therapy. Patients will be randomized into one of the three treatment arms. The study may enroll up to 150 patients per arm.
The lead investigator for the Phase 2 Azixa trial in metastatic melanoma is Minesh P. Mehta, M.D., Professor and Chair of Oncology at the University of Wisconsin.
"In earlier studies, Azixa showed biological activity in a broad range of tumors, and we hope to further define that activity in this second Phase 2 trial," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "We believe that Azixa has the potential to treat multiple forms of primary and metastatic brain cancer and we look forward to continue developing this potential in this second of a total of three separate Phase 2 studies."
Azixa has completed two Phase 1 clinical trials in patients with refractory solid tumors, one allowing brain metastases and the other requiring known brain metastases. The trials were designed to explore the safety and pharmacokinetics of Azixa and to find the maximum tolerated dose of the compound. The Phase 1 studies also found that Azixa demonstrated biological effects on patient tumors, including melanoma, that were consistent with the mechanism of the drug.
Azixa has a dual mode of action; it acts as a cytotoxin and a vascular disrupting agent (VDA). VDAs kill tumor cells by reducing the blood supply to a tumor. The disruption of the tumor vasculature results in acute ischemia followed by massive tumor cell death. Azixa is believed to selectively disrupt tumor vasculature, and not healthy tissue, by inhibiting the formation of microtubules. Tumors rely on microtubules to maintain the cytoskeletal structure of their new vasculature, whereas mature vascular endothelium of healthy tissue uses actin filaments to provide the needed structure.
About Metastatic Brain Cancer
There are approximately 170,000 new cases of metastatic brain tumors in the United States each year, and this number has risen steadily as survival from the originating primary tumors has improved. Brain metastases account for 20% of all cancer deaths each year in the United States. There are expected to be approximately 62,000 Americans diagnosed with melanoma this year. About half of all patients with melanoma will have brain metastases. Unfortunately, once a tumor of melanoma origin has been found in the brain, median survival is only three months. Most anticancer drugs are unable to cross the blood/brain barrier in sufficient concentration to achieve clinical benefit to the patient. There is currently no approved chemotherapy for metastatic brain cancer.
Azixa(TM) is a trademark of Myriad Genetics, Inc. in the United States and other countries.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to the trial design, enrollment for the Phase 2 trial of Azixa, the ability of the trial to compare the survival of patients treated with Azixa to those treated with temozolomide or the combination of Azixa plus temozolomide, and the potential of Azixa to treat multiple forms of primary and metastatic cancer as developed in this second of a total of three separate Phase 2 studies. These risks and uncertainties include, but are not limited to, our inability to further identify, develop and achieve commercial success for new products and technologies; our ability to discover drugs that are safer and more efficacious than our competitors; our ability to develop molecular diagnostic products that help assess which patients are subject to greater risk of developing diseases and who would therefore benefit from new preventive therapies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates, or that clinical trials will be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; our ability to protect our proprietary technologies; patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2006, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
Source: Myriad Genetics
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