Myriad Genetics Initiates Phase 2 Clinical Trial of Azixa™ in Brain Cancer
SALT LAKE CITY, UT, Mar 08, 2007—Myriad Genetics, Inc.
(NASDAQ: MYGN) (www.myriad.com) announced
today that it has initiated the first Phase 2 human clinical trial of
its therapeutic candidate, Azixa™ (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™ 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.
|