V.I. Technologies Presents Further Analysis of PA-457's Antiviral Activity Following a Single Oral Dose in HIV-infected Patients
26 July 2005 - 11:48PM
PR Newswire (US)
V.I. Technologies Presents Further Analysis of PA-457's Antiviral
Activity Following a Single Oral Dose in HIV-infected Patients, at
3rd International AIDS Society Conference 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 DATASOURCE: V.I.
Technologies CONTACT: Samuel K. Ackerman, M.D., Chairman and CEO of
V.I. Technologies, +1-617-926-1551, Web site:
http://www.vitechnologies.com/
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