Myriad Genetics Submits IND on MPC-6827 Cancer Drug
Phase I Clinical Trial in Patients With Solid Tumors
SALT LAKE CITY, December 9, 2004—Myriad Genetics, Inc.
(Nasdaq: MYGN), announced today that it has submitted an Investigational New
Drug (IND) application to the FDA to begin a Phase I clinical study with its
pro-apoptotic cancer drug candidate, MPC-6827.
The study is designed to evaluate the safety and pharmacokinetic profile
of MPC-6827 in patients with advanced solid tumors, in an escalating dose
regimen. In preclinical testing, MPC-6827 has been equally active against
multiple drug resistant cancers as with susceptible tumors, unlike many of the
current options in cancer chemotherapy, a limitation that represents a
significant unmet medical need.
"MPC-6827 has demonstrated the ability to inhibit tumor growth in
preclinical testing, with activity in animal models of human melanoma and
cancers of the ovary, breast, prostate, colon and pancreas," said Adrian
Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "This IND submission
is a major milestone in the development of this new drug candidate, and we are
excited about the possibility of demonstrating the same activity in cancer
patients that we have found in preclinical testing with MPC-6827."
In preclinical testing, MPC-6827 was demonstrated to be significantly more
active than the relevant standard-of-care chemotherapy drug at inhibiting
tumor growth in xenograft models of cancer. MPC-6827 was shown to be more
effective than doxorubicin in breast cancer, gemcitibine in pancreatic cancer,
irinotecan in colon cancer, carboplatin in ovarian cancer and demonstrated a
substantial inhibition of prostate cancer tumor growth, for which there is no
currently recognized standard of care.
Cancer cells may become resistant to chemotherapy through a cellular
function that actively excretes drug from the cell. The function is carried
out by multiple drug resistance (MDR) pumps and is the primary cause of
cancer's resistance to marketed drugs such as paclitaxel and vinblastine.
MPC-6827 was tested, in parallel with vinblastine and docetaxel, to determine
its relative susceptibility to MDR pumps. MPC-6827 was shown to be equally
effective in anti-cancer activity against the MDR cell lines tested,
suggesting that the drug candidate is not a substrate for MDR pumps. In
contrast, the potency of the currently marketed drugs was substantially
reduced against these MDR cell lines, requiring approximately 20 to 70 times
more drug in the case of docetaxel and 165 to 1,200 times more drug for
vinblastine, to reach the same level of activity that was measured in non-MDR
cells.
"MPC-6827 is Myriad's third clinical drug development program and we are
on schedule to move a fourth program into the clinic in the very near future,"
said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics,
Inc. "Our drug candidates address Alzheimer's disease and multiple types of
cancer, all diseases for which we believe there is significant unmet medical
need and very large potential markets."
MPC-6827 was identified by Myriad researchers from a family of compounds
acquired from Maxim Pharmaceuticals, Inc. All chemistry, lead optimization
and preclinical development on the compound was performed by Myriad or for
Myriad under its direction.
Myriad's Other Clinical Drug Development Programs
FLURIZAN™ (MPC-7869) is Myriad's investigative drug for Alzheimer's
disease and prostate cancer. This drug candidate is being investigated in a
large, well-controlled Phase II trial in Alzheimer's disease that is expected
to complete its clinical study period in the first quarter of calendar 2005.
It is also under study in a large, well-controlled, 3-year, Phase II/III
clinical trial in prostate cancer, which is expected to complete its clinical
study period in the second calendar quarter of 2006. Myriad is also
developing a broad range of pre-clinical compounds, with three late-stage
programs in the fields of cancer, HIV and emesis (cancer-induced nausea and
vomiting) that we believe will reach the human clinical trial stage during the
next 12 months.
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, including
statements relating to the potential safety and pharmacokinetic profile of
MPC-6827 in humans, the potential of MPC-6827 to treat melanoma and cancers of
the ovary, breast, prostate, colon and pancreas, the submission of MPC-6827 to
the FDA as an IND and moving MPC-6827 into human clinical trials, the
potential to move a fourth drug development program into the clinic in the
very near future, the development by Myriad of drug candidates for which there
is significant unmet medical need and very large potential markets, the
expected completion of clinical study periods in Phase II and Phase II/III
trials of the Company's Alzheimer's disease drug candidate in the first
quarter of calendar 2005 and the Company's prostate cancer drug candidate in
the second quarter of 2006, respectively, and the potential to move additional
late-stage programs into human clinical trials during the next 12 months.
These forward looking statements are based on management's current expectation
and are subject to certain risks and uncertainties that could cause actual
results to differ materially from those set forth or implied by forward-
looking statements. Risks and uncertainties that could cause actual results
to differ materially from those set forth in or implied by such forward-
looking statements include risks and uncertainties as to the extent of future
government regulation of Myriad Genetics' business; uncertainties as to
whether Myriad Genetics and its collaborators will be successful in
developing, and obtaining regulatory approval for, and commercial acceptance
of, therapeutic compounds; the risk that markets will not exist for
therapeutic compounds that Myriad Genetics develops or if such markets exist,
that Myriad Genetics will not be able to sell compounds, which it develops, at
acceptable prices; and the risk that the Company will not able to sustain
revenue growth for its predictive medicine business and products; and risks
associated with preclinical development activities that could cause delays in,
or even prevent, planned IND applications. These and other risks are
identified in the Company's filings with the Securities and Exchange
Commission, including the Company's Annual Report on Form 10-K for the fiscal
year ended June 30, 2004. All information in this press release is as of
December 9, 2004, and Myriad undertakes no duty to update this information
unless required by law.
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