WATERTOWN, Mass., July 26 /PRNewswire-FirstCall/ -- V.I. Technologies
("Vitex") and collaborators at the University at Buffalo's School of Pharmacy
and Pharmaceutical Sciences, Buffalo, NY, today presented a detailed analysis
of the Phase I/II clinical trial of its HIV drug candidate PA-457 at the 3rd
International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment
in Rio de Janeiro, Brazil. PA-457 is the first in a new class of HIV drugs
called Maturation Inhibitors, with broad activity against HIV, including
strains resistant to currently approved drugs, the most common cause of HIV
treatment failure.
The key results of this Phase I/II single dose study were reported
previously at the 12th Conference on Retroviruses and Opportunistic Infections
in February 2005. PA-457 was administered as a single oral dose of up to
250mg to HIV-infected patients who were not on other therapy. Following
administration, patients in the highest dose groups had reductions in viral
load of up to approximately 0.7 log10 and mean reductions compared to the
placebo group of approximately 0.4 log10 that were statistically significant.
In this study, two subjects with pre-existing drug-resistance mutations
exhibited greater than 0.5 log10 reductions from baseline following PA-457
treatment. PA-457 was well tolerated at all dose levels in the Phase I/II
study.
At the IAS Conference, a more complete analysis of the data was provided,
including generation of a model allowing detailed examination of the
correlation between PA-457's pharmacokinetics and the drug's antiviral effect.
This analysis confirmed and extended the findings presented previously that a
single dose of PA-457 was associated with a dose-related reduction in viral
load in HIV-infected patients. Researchers on the study included Drs. Abayomi
B. Ogundele, Patrick F. Smith and Alan Forrest of The University at Buffalo
and Dr. David E. Martin of Vitex.
"We are pleased to present further analysis of this important clinical
study, which confirms the antiviral activity of PA-457 against HIV, including
strains resistant to existing classes of drugs," commented Samuel K. Ackerman,
MD, Chairman and CEO of Vitex. "We look forward to presenting results of our
Phase 2a study at an upcoming scientific meeting." Vitex is currently
completing a Phase 2a study of PA-457 to examine the drug's antiviral effect
following 10 days of once daily oral dosing in HIV-infected patients not on
other therapy. The Company plans to submit the results of this study during
August 2005 as a late breaker abstract to the 45th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC), to be held in New Orleans, LA
September 21-24, 2005.
About Vitex
Vitex is developing the next generation of anti-infective products through
discovery and development of small molecule oral drugs for the treatment of
HIV and other major human viral diseases. Vitex's proprietary discovery
technologies and lead therapeutic candidate PA-457 focus on novel targets in
the virus life cycle, including virus fusion and virus maturation. For more
information on Vitex, please visit our web site at:
http://www.vitechnologies.com .
About the University at Buffalo
The University at Buffalo is a premier research-intensive public
university, the largest and most comprehensive campus in the State University
of New York. UB's more than 27,000 students pursue their academic interests
through more than 300 undergraduate, graduate and professional degree
programs. The university offers the only degrees in pharmacy, law and
architecture in the SUNY system, and is the home of the only comprehensive
public school of engineering and only school of informatics in New York State.
Except for the historical information contained herein, the matters
discussed are forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These
statements involve risks and uncertainties, such as the progress of clinical
development of PA-457 and the timing of results of clinical trials, the
execution of the Company's financing plans, the timely availability of new
products, market acceptance of the Company's products, the impacts of
competitive products and pricing, government regulation of the Company's
products, the Company's ability to complete product development collaborations
and other strategic transactions and other risks and uncertainties set forth
in the Company's filings with the Securities and Exchange Commission. These
risks and uncertainties could cause actual results to differ materially from
any forward-looking statements made herein.
CONTACT: Samuel K. Ackerman, M.D.
Chairman and CEO
617-926-1551
sackerman@vitechnologies.com
SOURCE V.I. Technologies
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Related links:
http://www.vitechnologies.com
CONTACT:
Samuel K. Ackerman, M.D., Chairman and CEO of
V.I. Technologies, +1-617-926-1551, sackerman@vitechnologies.com
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