OncoVista Innovative Therapies to Begin Enrolling Patients in a Phase I/II Study...

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Tue Jul 22, 2008 8:05am EDT

OncoVista Innovative Therapies to Begin Enrolling Patients in a Phase I/II Study of Cordycepin in Patients with Refractory TdT-Positive Leukemia

SAN ANTONIO--(Business Wire)--
OncoVista Innovative Therapies, Inc. (OTC BB: OVIT.OB), a
biopharmaceutical company engaged in the development and
commercialization of targeted cancer therapies and diagnostics,
announced today that patient recruitment has commenced in the
company's Phase I/II study of cordycepin for the treatment of patients
with terminal deoxynucleotidyl transferase (TdT)-positive refractory
leukemia. Participating clinical sites include the Dana Farber Cancer
Institute (Boston, MA) and the Cancer Therapy and Research Center (San
Antonio, TX).

   "Initiation of this Phase I/II clinical trial of cordycepin is an
important milestone for OncoVista. We believe cordycepin will prove to
be an effective and well-tolerated treatment option for many leukemia
patients who do not respond to other therapies. We are very excited to
have the trial up and running." stated Alexander L. Weis, Ph.D.,
President and Chief Executive Officer of OncoVista Innovative
Therapies.

   OncoVista has received Orphan Drug Designation from the FDA for
cordycepin in this indication, which affords the company seven years
of market exclusivity once the drug is approved for this indication.

   The goals of the Phase I portion of the cordycepin study are to
establish the recommended dose in the target population, determine
drug-related dose-limiting toxicities, and assess pharmacokinetics.
The goals of the Phase II portion of the study are to evaluate
efficacy at the recommended dose and confirm the safety profile
established in Phase I.

   About cordycepin and TdT positive leukemias

   Cordycepin (3'-deoxyadenosine) is a nucleoside analog that has
been shown in preclinical studies to have activity against
TdT-positive cells. Expression of TdT is one of the hallmarks of acute
lymphoblastic leukemia (ALL). In addition to ALL patients, subsets of
patients with acute myelogenous leukemia (AML) and chronic myelogenous
leukemia (CML) also express the TdT enzyme. Patients who have
TdT-positive leukemia (ALL, AML, or blastic CML) whose disease has
failed to respond to at least one standard treatment regimen and for
which no standard therapies are expected to result in durable
remission are eligible for enrollment in this trial.

   About OncoVista Innovative Therapies

   OncoVista is a biopharmaceutical company engaged in the
development and commercialization of targeted cancer therapies which
are more efficacious and less toxic. Further information on OncoVista
can be found at www.oncovista.com.

   Forward-Looking Statements: A number of statements contained in
this press release are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied in the applicable
statements. These risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in the
applicable statements.

OncoVista Innovative Therapies, Inc.
Alexander L. Weis, Ph.D., 210-677-6000
Chief Executive Officer
or
Investors:
Aimee Boutcher, 973-239-2878
aboutcher@aol.com

Copyright Business Wire 2008
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