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.
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