Neurobiological Technologies, Inc. Appoints Director of Regulatory Affairs
January 05 2005 - 9:30AM
PR Newswire (US)
Neurobiological Technologies, Inc. Appoints Director of Regulatory
Affairs RICHMOND, Calif., Jan. 5 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NASDAQ:NTII), a biotechnology
company engaged in the business of acquiring and developing central
nervous system (CNS) related drug candidates, today announced that
it has appointed Karl G. Trass as Director of Regulatory Affairs.
Trass, age 45, comes to NTI with twelve years of regulatory affairs
experience, including supervising the preparation and filing of
both new drug applications and biologics applications, which
resulted in four compounds receiving FDA marketing approval. Mr.
Trass has extensive experience in a variety of therapeutic areas,
including oncology and cardiovascular, and has had significant
regulatory experience outside of the U.S. Most recently, Trass was
Director of Regulatory Affairs with Sangamo BioSciences of
Richmond, CA. He held the same position at Gilead Sciences in
Foster City, CA, and was Associate Director of Regulatory Affairs
for Tularik in South San Francisco. Earlier, he was Senior Manager
for Regulatory Affairs at Genentech, also in South San Francisco,
and Senior Associate for Regulatory Affairs with Syntex of Palo
Alto. Trass holds a bachelor's degree from Indiana University where
he studied chemistry. Paul Freiman, president and CEO of NTI, said,
"Managing the regulatory relationship is a major challenge for
pharmaceutical companies, as illustrated by the recent controversy
over Vioxx and other COX-2 inhibitors. We expect that Karl's
experience and expertise will prove invaluable to NTI as we attempt
to develop drugs for the health care market. We expect that
Viprinex(TM), a late-stage reperfusion therapy for use in the
treatment of acute ischemic stroke, will enter Phase III studies in
2005, subject to FDA approval. And XERECEPT(TM), a novel agent for
the treatment of brain swelling associated with brain tumors, is
currently being evaluated in two pivotal Phase III clinical
studies, one of which began in April 2004. Each of these projects
will benefit from Karl's presence." Trass said, "The recent news
stories revolving around safety concerns with FDA-approved drugs
have created an environment in which pharmaceutical and
biotechnology companies must be very deliberate and careful in the
development and testing of their new drug candidates. For a company
like NTI, which now functions internationally, the added
responsibilities of meeting varying national requirements makes
regulatory affairs especially challenging. I am confident that my
background gives me the ability to meet that challenge. I look
forward to working with the rest of the NTI team." About
Neurobiological Technologies, Inc. Neurobiological Technologies,
Inc. is a biotechnology company engaged in the business of
acquiring and developing central nervous system (CNS) related drug
candidates. The company is focused on therapies for neurological
conditions that occur in connection with dementia, Alzheimer's
disease, ischemic stroke, neuropathic pain, and brain cancer.
Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements that
involve risks and uncertainties, including risks of failure
associated with our product candidates, risks associated with the
integration of acquired companies, products, technologies and
personnel and risks regarding the integration of new members of our
management team, as well as other risks detailed from time to time
in our Securities and Exchange Commission filings. Actual results
may differ materially from those projected. These forward- looking
statements represent our judgment as of the date of this release.
We disclaim, however, any intent or obligation to update these
forward-looking statements. DATASOURCE: Neurobiological
Technologies, Inc. CONTACT: Paul E. Freiman, President & CEO of
Neurobiological Technologies, Inc., +1-510-262-1730; or Cheryl
Schneider, VP - Investor Relations, or Jeff Myhre, VP - Editorial,
both of Porter, Le Vay & Rose, Inc., +1-212-564-4700, for
Neurobiological Technologies, Inc. Web site: http://www.ntii.com/
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