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, June 19, 2007—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®
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
breast cancer.
- 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® is a trademark of Myriad Genetics, Inc. in the United
States and other countries.
About Myriad
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.
About AstraZeneca
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.
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