ViroLogic Awarded $1.5 Million Grant to Fund Large-Scale Clinical Studies Evaluating Replication Capacity as a Predictive Tool f
June 24 2004 - 7:30AM
PR Newswire (US)
ViroLogic Awarded $1.5 Million Grant to Fund Large-Scale Clinical
Studies Evaluating Replication Capacity as a Predictive Tool for
the Clinical Management of HIV SOUTH SAN FRANCISCO, Calif., June 24
/PRNewswire-FirstCall/ -- ViroLogic, Inc. (NASDAQ:VLGC) announced
today that the company has been awarded a phase II Small Business
Innovation Research (SBIR) grant from the National Institutes of
Health (NIH) to assess HIV replication capacity (RC), a gauge of
viral "fitness," as a predictor of the pace of progression to
clinical AIDS. "Numerous clinical studies performed to date
strongly suggest a role for RC in the management of HIV-infected
patients, particularly in clinical scenarios where physicians
currently need better guidance. This grant will allow ViroLogic and
academic collaborators to examine the potential clinical utility of
RC more thoroughly so that we can better define exactly which
patients may benefit from assessments of RC," said Michael Bates,
M.D., Vice President of Clinical Research at ViroLogic. "We believe
this follow-on Phase II SBIR grant underscores our ability to
deliver on our scientific objectives and provides strong validation
of our research and assay development expertise." The SBIR grant
will make it possible for ViroLogic to evaluate RC in multiple
large cohorts that include a variety of patient subtypes and span
the breadth of treatment experience from untreated to heavily
treated HIV-infected individuals, as well as to gain a better
understanding of how to interpret RC values for optimum clinical
benefit. This phase II grant is a continuation of a two-year phase
I grant originally awarded in July 2001 that was used to
successfully develop a rapid, reproducible assay for the assessment
of RC. Full laboratory validation has been completed and the assay
has achieved CLIA and CAP certification. About Replication Capacity
(RC) RC provides a measure of the ability of HIV to replicate and
to destroy the immune system. RC testing is only commercially
available with ViroLogic's PhenoSense(TM) and PhenoSense GT(TM)
assays, and is currently included with those resistance test
results free of charge. Genetic changes (mutations) in HIV that
confer drug resistance often impair the virus' ability to replicate
efficiently and lead to reduced viral RC. Previous clinical studies
have found that patients experiencing treatment failure due to drug
resistance characterized by increasing viral load with stable CD4
T-cell counts also have virus with a relatively low RC. Other data
suggest that RC is not simply a surrogate for drug resistance, but
rather is an inherent characteristic of HIV that impacts the
pathogenicity of different viral isolates. Taken together, these
data suggest potential roles for RC in the management of
HIV-infected patients in both treatment-na�ve and
treatment-experienced situations. About ViroLogic ViroLogic is a
biotechnology company advancing individualized medicine by
discovering, developing and marketing innovative products to guide
and improve treatment of serious viral diseases such as AIDS and
hepatitis. The Company's products are designed to help doctors
optimize treatment regimens that lead to better patient outcomes
and reduced costs. ViroLogic's technology is also being used by
numerous biopharmaceutical companies to develop new and improved
anti-viral therapeutics and vaccines targeted at emerging
drug-resistant viruses. More information about the Company and its
technology can be found on its web site at
http://www.virologic.com/. Certain statements in this press release
are forward-looking, including statements regarding activities
expected to occur in connection with the SBIR grant discussed in
this press release and the potential role for RC in the management
of HIV-infected patients. These forward-looking statements are
subject to risks and uncertainties and other factors, which may
cause actual results to differ materially from the anticipated
results or other expectations expressed in such forward-looking
statements. These risks and uncertainties include, but are not
limited to, the risk that the Company may not utilize the full
amounts authorized under the grant in the manner discussed in this
press release, the risk that the programs funded by this grant may
not achieve desired results, whether ViroLogic successfully
introduces new products, whether others introduce competitive
products, the risk that the Company's products for patient testing
may not continue to be accepted or that increased demand from drug
development partners may not develop as anticipated, the risk that
gross margins may not increase as expected, the risk that ViroLogic
may not continue to realize anticipated benefits from its
cost-cutting measures, the timing of pharmaceutical company
clinical trials, whether payors will authorize reimbursement for
its products, whether the FDA or any other agency will decide to
regulate ViroLogic's products or services, whether the Company will
encounter problems or delays in automating its processes, whether
intellectual property underlying the Company's PhenoSense
technology is adequate, whether licenses to third party technology
will be available, whether ViroLogic is able to build brand loyalty
and expand revenues, and whether ViroLogic will be able to raise
sufficient capital when required. For a discussion of other factors
that may cause ViroLogic's actual events to differ from those
projected, please refer to the Company's most recent annual report
on Form 10-K and quarterly reports on Form 10-Q, as well as other
subsequent filings with the Securities and Exchange Commission.
DATASOURCE: ViroLogic, Inc. CONTACT: Karen Wilson, CFO of
ViroLogic, Inc., +1-650-624-4164, or Web site:
http://www.virologic.com/
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