Healthcare Industry News: oxaliplatin
News Release - March 8, 2007
Myriad Genetics Initiates Phase 2 Clinical Trial of Azixa(TM) in Brain CancerSALT LAKE CITY, UT--(Healthcare Sales & Marketing Network)--Mar 8, 2007 -- Myriad Genetics, Inc. (NasdaqGS:MYGN ) (www.myriad.com) announced today that it has initiated the first Phase 2 human clinical trial of its therapeutic candidate, Azixa(TM) (MPC-6827), in patients with brain cancer.
The Phase 2 trial is designed to determine the safety profile of Azixa and the extent of its ability to improve the survival of patients with glioblastoma multiforme, the most common form of primary brain cancer. The trial will compare the survival of patients treated with Azixa to those treated with oxaliplatin, and to those treated with Azixa plus oxaliplatin.
The trial is designed as an adaptive, open label, multiple dose study in patients with recurring or relapsed glioblastoma multiforme. The first stage of the trial is designed to determine the safety and the maximum tolerated dose of Azixa in combination with oxaliplatin, in approximately 16 patients. 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 survival of patients treated with the Azixa/oxaliplatin combination therapy compared to Azixa alone or oxaliplatin alone. Patients will be randomized into one of three treatment arms. Periodically, an analysis of efficacy will be conducted to determine the final size of the second stage of the trial.
The lead investigator for the Phase 2 Azixa trial in glioblastoma multiforme is Alfred Yung, M.D., Professor and Chair, Department of Neuro-Oncology at the MD Anderson Cancer Center in Houston, TX. The trial is expected to enlist the participation of approximately 50-70 centers in total, through both stages of the Phase 2, in the United States and Europe.
"We are pleased to continue the clinical development of this exciting compound," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The ability of Azixa to cross the blood-brain barrier gives us hope that because it can reach the site of the disease, it could be a more effective therapeutic than anything available today."
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 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 GBM Brain Cancer
There are approximately 18,000 primary brain tumors and 180,000 new cases of metastasis to the brain in the United States each year, and the number of metastatic tumors has risen steadily as the treatment of primary tumors has improved. Glioblastoma multiforme (GBM) is by far the most common and most aggressive primary brain tumor. The standard of care for patients with GBM is primarily surgery and whole brain radiation. The 5 year survival rate of the disease has remained unchanged over the past 30 years, and stands at less than three percent. Even with complete surgical resection of the tumor, combined with the best available treatment, the survival rate for GBM remains very low. 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 expected trial design and enrollment for the Phase 2 trial of Azixa and our hope that Azixa may be a more effective therapeutic, if approved, than anything available today. 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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