Myriad Genetics Initiates Phase 2 Clinical Trial of Azixa in Lung Cancer
80% of Lung Cancer Cases Spread to the Brain
Salt Lake City, UT, Aug 16, 2007—Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) announced
today that it has initiated a third Phase 2 human clinical trial of
its therapeutic candidate, Azixa™ (MPC-6827), in patients with
non-small-cell lung cancer that has spread to the brain. The two
previously announced Phase 2 trials are studying primary brain cancer
and melanoma that has spread to the brain.
The Phase 2 trial is designed to determine the safety profile of
Azixa and to assess the extent of its ability to improve the overall
survival of patients with non-small-cell lung cancer that has spread
to the brain. The primary endpoint of the trial is a comparison of
the overall survival of patients treated with Azixa alone to those
treated with temozolomide or the combination of Azixa plus
temozolomide. Secondary endpoints include progression-free survival
and a quality of life assessment of patients.
The trial is an adaptive, open-label, multiple-dose study in patients
with non-small-cell lung cancer that has spread to the brain. Patients
will be randomized into one of three treatment arms. The study may
enroll up to 150 patients per arm.
"Due to Azixa's demonstrated ability to cross the blood-brain barrier
and its activity in drug-resistant tumors, along with the compelling
safety data from our Phase 1 trials, we have decided to accelerate the
development of Azixa through this additional Phase 2 trial," said
Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc.
AZIXA™ Phase 1 Study Results Summary
Azixa has completed two Phase 1 clinical trials in a total of 66
patients, one in patients with refractory solid tumors that may also
have had brain metastases and the other in patients with 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. In the Phase 1 studies, Azixa appeared to have a
biological effect on patients' metastases from many different primary
tumors, including non-small-cell lung cancer, which is consistent
with the mechanism of the drug candidate. Patients in the studies had
typically failed from five to seven previous chemotherapy drugs and
were determined by their physicians to be in the terminal stage of
the disease, without further approved therapeutic options remaining.
Of the 32 patients that received a therapeutic dose of Azixa, 38%
responded as determined by tumor shrinkage, stable disease or
disruption of the vasculature of the tumor. Two patients with brain
metastases were still alive and stable after 15 months of treatment
with Azixa.
During the Phase 1 trials, no apparent effect on any laboratory
parameter was observed, including no reduction in neutrophils,
platelets or hemoglobin. Importantly, there was no evidence of
neurotoxicity, peripheral neuropathy or effect on QTc interval. There
were a total of 55 serious adverse events in 34 patients in the two
studies, however only 4 of these events in 3 different patients were
classified as possibly or definitely drug-related. The dose-limiting
toxicity was acute coronary syndrome, which was observed in none of
the patients at 3.3 mg/m2, one of six patients at 3.9 mg/m2, and in
two of six patients at 4.5 mg/m2. The maximum tolerated dose was set
at 3.3 mg/m2. There was a transient increase in blood pressure during
infusion and for several hours post-infusion.
AZIXA Mode of Action
Azixa has a dual mode of action; in preclinical studies it was shown
to act as a vascular disrupting agent (VDA) and a cytotoxin. 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. We believe Azixa selectively
disrupts tumor vasculature, and not healthy tissue, by inhibiting the
formation of microtubules. Tumors require new blood vessels to assure
sufficient supply of blood, and new blood vessels rely on
microtubules to maintain their structure, whereas mature blood
vessels of healthy tissue uses a different structural component,
actin filaments, to provide the needed structure.
About Non-Small-Cell Lung Cancer
According to the American Cancer Society, there are expected to be
approximately 185,000 Americans diagnosed with non-small-cell lung
cancer this year. About 80% of all patients with non-small-cell lung
cancer who survive for more than two years, will have brain
metastases. This is in part because most anticancer drugs are unable
to cross the blood/brain barrier in sufficient concentration to
achieve clinical benefit to the patient. The use of such
chemotherapeutic agents can transiently weaken the blood-brain
barrier and allow systemic disease to be seeded in the brain, leaving
the brain susceptible to tumor growth. Once a tumor of non-small-cell
lung cancer origin has been found in the brain, median survival is
generally reported as just three to six months. There is currently no
FDA-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
initiation, enrollment and successful completion of a third Phase 2
human clinical trial of the Company's therapeutic candidate,
Azixa(TM) (MPC-6827), in patients with non-small-cell lung cancer
that has spread to the brain; the design of the trial to determine
the safety profile of Azixa and to assess the extent of its ability
to improve the overall survival of patients with non-small-cell lung
cancer that has spread to the brain; the ability to assess the
primary endpoint of the trial which is a comparison of the overall
survival of patients treated with Azixa alone to those treated with
temozolomide or the combination of Azixa plus temozolomide; the
ability to assess the secondary endpoints of the trial which include
progression-free survival and a quality of life assessment of
patients; the enrollment of patients in the trial of up to 150
patients per arm in three treatment arms; the accelerated development
of Azixa through this additional Phase 2 trial based on the
demonstrated ability of Azixa to cross the blood-brain barrier, show
activity in drug-resistant tumors and compelling safety data from the
Company's Phase 1 trials; and the belief that Azixa selectively
disrupts tumor vasculature, and not healthy tissue, by inhibiting the
formation of microtubules. 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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