results of its multi-center, double-blind, placebo-controlled human clinical trial of MPC-7869 (R-flurbiprofen)in prostate cancer

http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=24800067

Statistical significance was not achieved for either of the endpoints, and
therefore the Company does not intend to pursue further development of
this compound in cancer.


01/08/07 -- Myriad Genetics, Inc. (NASDAQ:MYGN ) announced today the
results of its multi-center, double-blind, placebo-controlled human
clinical trial of MPC-7869 (R-flurbiprofen) in prostate cancer. The
clinical trial was designed to evaluate the safety of MPC-7869 and to
consider its potential efficacy in slowing the rate of progression of
prostate cancer among 246 patients with advanced disease.


Patients participating in the study were assigned to one of three arms
(800 mg once daily or 800 mg twice daily of MPC-7869 or placebo). The two
primary clinical endpoints of the trial were the time to systemic disease
progression and the change in velocity of Prostate Specific Antigen
levels. Statistical significance was not achieved for either of the
endpoints, and therefore the Company does not intend to pursue further
development of this compound in cancer.

Myriad will continue to concentrate its efforts on the compound's
demonstrated activity in Alzheimer's disease.

The study showed that MPC-7869 was well tolerated over long-term
administration in an elderly population, confirming the data from previous
studies. With the completion of this study, Myriad now has over 1,200
patient-years of safety data on this compound, with a maximum exposure
period of 44 months.

The study showed no significant differences in adverse events between the
placebo and drug-treated arms. Additionally, during the course of the
study, there were no significant differences in serious adverse events
between the drug and placebo arms. Twenty-two patients experienced serious
adverse events in the placebo group, compared to 22 in the 800 mg once
daily group and 23 in the 800 mg twice daily group. In particular, there
were no significant differences between the drug-treated and placebo
groups for adverse gastrointestinal, myocardial or cerebrovascular events.

"The safety data collected in this trial will be very useful to our
program in Alzheimer's disease," said Peter Meldrum, President of Myriad
Genetics, Inc. "The age of the study population is similar and the 800 mg
twice daily dose of MPC-7869 is identical to that of our two ongoing Phase
3 trials in Alzheimer's disease."

Myriad Genetics, Inc. is a biopharmaceutical company focused on the
development of novel healthcare products. The Company develops and markets
molecular diagnostic 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 concentration of the Company?s efforts on
MPC-7869?s demonstrated activity in Alzheimer?s disease; the utility of
the safety data collected in the Phase 2 trial to the Company?s program in
Alzheimer?s disease; the tolerability of MPC-7869 in long-term
administration in an elderly population; and the statistical significance
of adverse and serious adverse events in studies of MPC-7869, including
gastrointestinal, myocardial or cerebrovascular events.

These forward looking statements are based on management?s current
expectations 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.

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 January 8,
2007, and Myriad undertakes no duty to update this information unless
required by law.

Source: Myriad Genetics

.

Relevant Pages

  • Re: Canadian doctors coming to the US
    ... >> Herman denies that the usual test of statistical significance is a vaid ... > exposed to a disease without treatment died, ... People would see from the figures what the effect was and the risk ...
    (sci.med.cardiology)
  • Re: Canadian doctors coming to the US
    ... >> Herman denies that the usual test of statistical significance is a vaid ... > exposed to a disease without treatment died, ... People would see from the figures what the effect was and the risk ...
    (sci.med.nutrition)
  • Re: Canadian doctors coming to the US
    ... >> Herman denies that the usual test of statistical significance is a vaid ... > exposed to a disease without treatment died, ... People would see from the figures what the effect was and the risk ...
    (sci.med)
Loading