Myriad Genetics Collaborates With AstraZeneca on Phase 2 Trials
Studies to Determine If Women With BRCA1 & BRCA2 Mutations
May Receive Greater Benefit From New Treatment
SALT LAKE CITY, UT, Jun 19, 2007 (MARKET WIRE via COMTEX News Network) -- Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) today announced the start of two Phase II trials for a new compound being tested to treat patients with BRCA1 & BRCA2 positive breast and ovarian cancer. AstraZeneca's (NYSE: AZN) KuDOS Pharmaceuticals is running the international, multi-center clinical trial and will reimburse Myriad for provision of the molecular diagnostic testing for the trial. Myriad has exclusive worldwide rights to diagnostic applications of the findings from the study and KuDOS, all rights to its therapeutic applications.
The ICEBERG (International Collaborative Expertise for BRCA Education and Research through Genetics) studies are intended to evaluate the ability of AZD2281 (KU-0059436), a PARP (poly-ADP-ribose polymerase) inhibitor, to treat patients with breast cancer or ovarian cancer associated with an inherited mutation in one of the cancer genes, BRCA1 or BRCA2.
The BRCA1 and BRCA2 genes are involved in DNA repair and when this function is lost due to a mutation, cells are unable to repair breaks in DNA. Research has shown that women who inherit mutations in either the BRCA1 or BRCA2 genes are predisposed to a higher incidence of breast and ovarian cancer. It is hypothesised that PARP inhibitors work by inhibiting DNA repair in the BRCA deficient tumour cells, thereby overloading these cells with DNA damage and selectively killing these cells. The trials will evaluate the extent of patient response to the treatment and time-to-disease progression amongst other indicators of clinical benefit.
Lead Investigator for the trials, Dr Andrew Tutt, clinician scientist at the Breakthrough Breast Cancer Research Centre and breast oncologist at Guy's Hospital, London, said: "Having demonstrated the potential of PARP inhibitors through lab work carried out at the Breakthrough Research Centre, we hope these trials will help us confirm the results in the clinic, leading to the development of a targeted treatment for this type of cancer."
Gregory Critchfield, M.D., President of Myriad Genetic Laboratories, Inc., commented, "There is enormous potential for patient benefit from the synergy between the molecular diagnosis of breast or ovarian cancer and a specific, targeted therapeutic. Myriad's BRACAnalysis(R) test is a highly sensitive proven method for finding mutations in BRCA1 and BRCA2. Individuals with breast or ovarian cancer who carry these mutations are candidates for the PARP inhibitor therapy approach. It may become more important than ever to know whether a patient with breast or ovarian cancer is BRCA1 or BRCA2 mutation positive."
ICEBERG Study Details
The two studies will enroll up to 40 patients each:
-- Breast study: phase II, open-label, non-comparative, international,
multicenter study to assess the efficacy and safety of AZD2281
given orally in patients with advanced BRCA1- or BRCA2-associated
- Entry criteria - measurable advanced breast cancer (stage
IIIB/IIIC/IV) and confirmed BRCA+ status.
-- Ovarian study: phase II, open-label, non-comparative,
international, multicenter study to assess the efficacy and safety
of AZD2281 given orally in patients with advanced BRCA1- or
BRCA2-associated ovarian cancer.
- Entry criteria - measurable advanced ovarian cancer (stage
IIIB/IIIC/IV) and confirmed BRCA+ status.
BRACAnalysis(R) 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.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index. For more information about AstraZeneca, please visit: www.astrazeneca.com KuDOS Pharmaceuticals Ltd is a wholly-owned subsidiary of AstraZeneca.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include the Company's exclusive worldwide rights to diagnostic applications of the findings from the study; the enormous potential for patient benefit from the synergy between the molecular diagnosis of breast or ovarian cancer and a specific, targeted therapeutic. 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.
William A. Hockett
Exec. VP Communications
Myriad Genetics, Inc.
Posted: June 2007