Myriad Genetics Initiates Phase 2 Clinical Trial of Azixa in Metastatic Brain Cancer
SALT LAKE CITY, UT, March 27, 2007—Myriad Genetics, Inc. (NASDAQ: MYGN)
(www.myriad.com) announced
today that it has initiated a Phase 2 human clinical trial of its
therapeutic candidate, Azixa™ (MPC-6827), in patients with
melanoma that has spread to the brain.
The Phase 2 trial is designed to determine the safety profile of
Azixa and the extent of its ability to improve the overall survival
of patients with melanoma skin cancer with brain metastases. The
trial will compare the survival of patients treated with Azixa to
those treated with temozolomide or the combination of Azixa plus
temozolomide.
The trial is designed as an adaptive, open label, multiple dose study
in patients with metastatic melanoma. The first stage of the trial is
designed to determine the safety and the maximum tolerated dose of
Azixa in combination with temozolomide. The format for stage 1 is a
six patient cohort, given daily temozolomide and weekly Azixa for six
weeks. 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 overall survival of patients treated with Azixa
alone, compared to temozolomide alone or the Azixa/temozolomide
combination therapy. Patients will be randomized into one of the
three treatment arms. The study may enroll up to 150 patients per
arm.
The lead investigator for the Phase 2 Azixa trial in metastatic
melanoma is Minesh P. Mehta, M.D., Professor and Chair of Oncology at
the University of Wisconsin.
"In earlier studies, Azixa showed biological activity in a broad
range of tumors, and we hope to further define that activity in this
second Phase 2 trial," said Adrian Hobden, Ph.D., President of Myriad
Pharmaceuticals, Inc. "We believe that Azixa has the potential to
treat multiple forms of primary and metastatic brain cancer and we
look forward to continue developing this potential in this second of
a total of three separate Phase 2 studies."
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, including
melanoma, 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 Metastatic Brain Cancer
There are approximately 170,000 new cases of metastatic brain tumors
in the United States each year, and this number has risen steadily as
survival from the originating primary tumors has improved. Brain
metastases account for 20% of all cancer deaths each year in the
United States. There are expected to be approximately 62,000
Americans diagnosed with melanoma this year. About half of all
patients with melanoma will have brain metastases. Unfortunately,
once a tumor of melanoma origin has been found in the brain, median
survival is only three months. 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 trial
design, enrollment for the Phase 2 trial of Azixa, the ability of the
trial to compare the survival of patients treated with Azixa to those
treated with temozolomide or the combination of Azixa plus
temozolomide, and the potential of Azixa to treat multiple forms of
primary and metastatic cancer as developed in this second of a total
of three separate Phase 2 studies. 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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