NEW YORK -- INNOVIVE Pharmaceuticals, Inc. (OTCBB:IVPH), a biopharmaceutical company headquartered in Manhattan, announced today that a Phase I clinical trial investigating INNO-305 in acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), mesothelioma and non-small cell lung cancer (NSCLC) has enrolled its first patient. The trial is being conducted by Lee Krug, M.D., of the Thoracic Oncology Service, and Peter Maslak, M.D., of the Leukemia Service at Memorial Sloan Kettering Cancer Center in New York.
The study is an open label fixed dose trial and will study the safety, tolerability, pharmacokinetics and preliminary efficacy of INNO-305. The vaccine will be tested in patients with hematologic malignancies and solid tumors for which there is evidence of WT1 expression.
INNO-305 was invented by David A. Scheinberg, M.D., Ph.D., Chairman of the Molecular Pharmacology and Chemistry Program at Memorial Sloan-Kettering Cancer Center. Dr. Scheinberg notes that pre-clinical research has demonstrated promising characteristics with significant potential as a cancer therapeutic.
INNO-305, a WT1 peptide therapeutic vaccine, is unique among WT1 peptide immunotherapies because of its ability to stimulate both CD8 and CD4 T-cells. It is believed that stimulating both types of T-cells may result in a more robust and ubiquitous immune response. As an added measure, INNO-305 utilizes an approach in which the wild-type WT1 peptide sequences are altered to improve the ability of the drug to activate T-cells.
Clinical studies with other WT1 peptide immunotherapies have already shown promising results in patients with AML and other cancers. By using modified, non-natural peptides that stimulate both CD4 and CD8 T-cells, INNO-305 may offer an advantage over other WT1 peptide immunotherapy approaches.
"With the initiation of the INNO-305 trial, Innovive now has three clinical stage oncology compounds. We have taken significant strides over the last twelve months and continue to build a meaningful oncology portfolio," said Steven Kelly, President and CEO, Innovive Pharmaceuticals.
Innovive licensed worldwide development rights for INNO-305 in January 2006 from Memorial Sloan-Kettering Cancer Center in New York.
About INNOVIVE Pharmaceuticals
Innovive Pharmaceuticals, Inc. is a public biopharmaceutical company headquartered in New York, N.Y. The company's mission is to acquire, develop and commercialize novel therapeutics addressing significant unmet medical needs in the fields of oncology and hematology. For additional information visit www.innovivepharma.com.
This press release contains forward-looking statements that involve risks and uncertainties that could cause INNOVIVE's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. 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. Among other things, there can be no assurances that any of INNOVIVE's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of INNOVIVE's product candidates, the risk that the results of clinical trials may not support INNOVIVE's claims, INNOVIVE's reliance on third party researchers to develop its product candidates and its lack of experience in developing pharmaceutical products. These and other risks are discussed in INNOVIVE's Registration Statement on Form 10 filed with the SEC. INNOVIVE assumes no obligation to update these forward-looking statements, except as required by law.
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