SAN ANTONIO, TX--(Marketwire -11/28/11)- OncoVista Innovative Therapies, Inc. (OTC.BB: OVIT.OB - News), a biopharmaceutical company engaged in the development and commercialization of targeted cancer therapies with reduced toxicity and improved patient safety, announced today that it has entered into an agreement with Oncology Therapeutic Development (OTD), a consulting and early Clinical Development focused CRO, to initiate a Phase Ib clinical trial of Cordycepin associated to Pentostatin for the treatment of patients with terminal deoxynucleotidyl transferase (TdT)-positive refractory leukemia.
The goals of this collaboration project are to quickly and economically complete the Phase Ib development step, through the intracellular and plasma real time PK/PD assessment to optimize the dose and scheduling of both Cordycepin and Pentostatin.
"We have engaged OTD and its consultant's team to initiate a Phase Ib trial of Cordycepin. We are excited because Prof. Esteban Cvitkovic and his team have been instrumental in the development of several successfully registered anticancer agents such as Cisplatin, Oxaliplatin, Amifostine, Irinotecan, Docetaxel and ET-743s," 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.
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) which have failed 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.