VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid(TM), a Novel Topical Agent for the Treatment of Various Ski
01 Juli 2008 - 3:00PM
Business Wire
VioQuest Pharmaceuticals (OTCBB: VOQP) today announced the
submission of a 510(k) application to the United States Food and
Drug Administration (FDA). The application seeks marketing
clearance for Xyfid� (1% uracil topical), a topical skin
preparation intended to relieve and to manage the burning and
itching associated with various dermatoses including atopic
dermatitis, irritant contact dermatitis, radiation dermatitis and
other dry skin conditions, by maintaining a moist wound and skin
environment. If cleared by the FDA, Xyfid� will be the company's
first commercial product. "The submission of our 510(k) application
for Xyfid� marks an important milestone in our company's history
and we look forward to reporting our progress on this and on other
fronts in the months ahead," said Michael D. Becker, president and
CEO of VioQuest Pharmaceuticals. �With this submission, we are also
well positioned to consider opportunities for partnership or
collaboration to support the commercialization strategy for this
novel supportive care oncology product candidate.� About VioQuest
Pharmaceuticals VioQuest Pharmaceuticals is a New Jersey-based
biotechnology company dedicated to becoming a recognized leader in
the successful development of novel drug therapies targeting both
the molecular basis of cancer and side effects of treatment.
VioQuest�s oncology portfolio includes: Xyfid� (1% uracil topical),
for the treatment of dry skin conditions and to manage the burning
and itching associated with various dermatoses; VQD-002
(triciribine phosphate monohydrate), a targeted inhibitor of Akt
activation; and Lenocta� (sodium stibogluconate), an inhibitor of
certain protein tyrosine phosphatases such as SHP-1, SHP-2, and
PTP1B. Further information about VioQuest can be found at
www.vioquestpharm.com. This press release contains forward-looking
statements that involve risks and uncertainties that could cause
VioQuest's actual results and experiences to differ materially from
the anticipated results and expectations expressed in these
forward-looking statements. These forward-looking statements
concern the timing, progress and results of the clinical
development, regulatory processes, potential clinical trial
initiations of VioQuest�s product candidates, as well as our
ability to complete strategic transactions. These statements are
often, but not always, made through the use of words or phrases
such as anticipates, expects, plans, believes, intends, and similar
words or phrases. These statements are based on current
expectations, forecasts and assumptions that are subject to risks
and uncertainties, which could cause actual outcomes and results to
differ materially from these statements. These statements are
subject to various risks and uncertainties and include VioQuest�s
immediate need for additional capital to cover its current
obligations and future operating expenses and fund its clinical
development programs, the possibility that the results of clinical
trials will not support VioQuest's claims, the possibility that
VioQuest's development efforts relating to its product candidates
will not be successful, the inability to obtain regulatory approval
of VioQuest's product candidates, VioQuest's reliance on
third-party researchers to develop its product candidates, its lack
of experience in developing and commercializing pharmaceutical
products, and the possibility that its licenses to develop and
commercialize its product candidates may be terminated. Additional
risks are described in VioQuest's Annual Report on Form 10-KSB for
the year ended December 31, 2007. VioQuest assumes no obligation
and does not intend to update these forward-looking statements,
except as required by law.
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