SALT LAKE CITY, Nov. 18, 2009 (GLOBE NEWSWIRE) -- Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) today announced the presentation of initial clinical data from an ongoing Phase 2a study of Azixa(TM) (MPC-6827), a microtubule destabilizing agent in stage 4 melanoma patients. Azixa is in two additional phase 2 studies in recurrent glioblastoma multiforme (GBM). Myriad Pharmaceuticals further announces that it has received orphan drug status for Azixa in GBM.
Twenty-two patients with refractory metastatic melanoma have been studied at three different doses of Azixa. The combination of Azixa at all concentrations with fixed dose temozolomide, including the previously determined single agent maximum tolerated dose of Azixa, was safe and well-tolerated. A dose reduction of Azixa was not required when combined with temozolomide in these patients.
Employing modified RECIST criteria, ten patients achieved stable disease and two patients achieved confirmed partial responses. One patient had stable disease for 4 months before achieving a partial response for an additional 8 months. A second patient had stable disease for 2 months before achieving a partial response for an additional 4 months. The median progression free survival of 2.8 months is favorable when compared with a randomized phase 3 study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma (1.9 and 1.5 months, respectively; J Clin Oncol 18:158-166, 2000). Data collection and patient follow-up in this study are continuing.
"We are very encouraged with the duration of responses in this clinical trial with stage 4 melanoma patients," said Dr. Adrian Hobden, President and CEO of Myriad Pharmaceuticals. "We are also pleased to see that Azixa could be combined with temozolomide without adding any further toxicity to the treatment regime."
As reported in previous non-clinical studies, Azixa penetrates and concentrates in brain tissues to achieve levels in brain tissues as great as 3000% of plasma levels. Azixa is currently in two additional studies for the treatment of patients with recurrent GBM. The Company will review interim data from clinical studies in GBM patients and evaluate all clinical results before finalizing additional clinical study plans.
Presentation schedule:
Abstract # C230 (Nov. 18, 12:30 - 2:30 PM EST): MPC-6827 is safely combined with temozolomide for the treatment of patients with metastatic melanoma.
The presentation will be available as a PDF file on the Myriad Pharmaceuticals' website (http://www.myriadpharma.com).
About Azixa (MPC-6827)
Azixa, MPI's most advanced cancer drug candidate, is being developed for the treatment of advanced cancers with brain involvement. Azixa is a novel small molecule that acts as a microtubule destabilizing agent, causing an arrest of cell division with subsequent programmed cell death, or apoptosis, in cancer cells. Several currently marketed clinically effective drugs share the identical mechanism of action. Importantly, however, Azixa has two unique, distinguishing characteristics. In non-clinical studies, Azixa has demonstrated the ability to effectively cross the blood-brain barrier and accumulate in the brain at levels as much as 3000% of that in plasma. In addition, Azixa does not appear to be subject to multiple drug resistance (MDR) mechanisms.
Azixa represents a unique therapeutic opportunity with the potential to treat patients with any primary or secondary (metastatic) brain cancer or any cancer that has developed resistance to conventional chemotherapeutics. Azixa is currently in clinical studies in patients with glioblastoma multiforme and metastatic melanoma.
About Metastatic Melanoma
Melanoma incidence is increasing at a significant rate worldwide and it is estimated that about 70,000 individuals will be diagnosed with melanoma in the U.S. this year. According to National Cancer Institute epidemiological statistics, the annual incidence of invasive cutaneous melanoma increased by 50% among U.S. females aged 15-39 between 1980 and 2004. In addition, melanoma is the most common cancer diagnosed in men over the age of 50. The brain is a preferential site for melanoma metastases; 40-60% have confirmed brain lesions. In one study of 702 melanoma patients known to have metastases in the brain, the brain tumors contributed to death in 94.5% of cases.
Brain metastases are a common problem in late stage cancers with an annual incidence of approximately 170,000 patients in the U.S. There are currently no approved therapies for the treatment of brain metastases. Frequently, primary and secondary tumors develop MDR and stop responding to the chemotherapeutic agents in clinical use, thus significantly limiting their effectiveness and leaving patients with few therapeutic options.
About Myriad Pharmaceuticals, Inc.
Myriad Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection. Our pipeline includes clinical and pre-clinical product candidates with distinct mechanisms of action and novel chemical structures that have the potential to be first-in-class and/or best-in-class therapeutics. For more information visit www.myriadpharma.com.
The Myriad Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6327
Azixa is a trademark or registered trademark of Myriad Pharmaceuticals, Inc. in the United States and foreign countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential efficacy of Azixa. These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that we may be unable to further identify, develop and achieve commercial success for new products and technologies; the risk that we may be unable to discover drugs that are safer and more efficacious than our competitors; the risk that we may be unable to develop and maintain manufacturing capabilities for our products; 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 not 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; the risk that we may be unable to protect our proprietary technologies; the risk of 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. - Risk Factors" in our Annual Report on Form 10-K for the year ended June 30, 2009, 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 Pharmaceuticals undertakes no duty to update this information unless required by law.