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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/