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Calvert Research Portfolio Company Oncoceutics, Inc. Receives FDA Clearance to begin Phase I/II Trial of ONC201

ONC201 will initially be studied in Phase I safety and dose ranging clinical studies in patients suffering from advanced cancer, including refractory solid tumors.
    CARY, NC, March 14, 2014 /24-7PressRelease/ -- Calvert Research, LLC, a business unit of Calvert Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) recently accepted the Investigational New Drug (IND) application for the Phase I/II trial of ONC201, the lead experimental drug compound being developed by Oncoceutics, Inc., a Calvert Research portfolio company. ONC201 will initially be studied in Phase I safety and dose ranging clinical studies in patients suffering from advanced cancer, including refractory solid tumors.

ONC201 is a first-in-class small molecule compound that has shown impressive efficacy in a wide range of very aggressive animal tumor models such as glioblastoma multiforme, prostate cancer, melanoma, sarcomas, and mantle cell lymphoma. ONC201 exerts anti-cancer activity via inactivation of two of the most critical cancer "survival kinase" pathways, ERK and AKT, and employs TRAIL and one of its potent pro-apoptotic receptors, DR5, as apoptotic effectors.

Calvert Research and Oncoceutics previously executed an Investment Partnership Agreement in the third quarter of 2013 to support completion of IND enabling GLP animal pharmacology, toxicology, and pharmacokinetic testing of ONC201 by utilizing the extensive resources of Calvert's CRO affiliate, Calvert Laboratories, Inc. Calvert Research made a significant capital investment in Oncoceutics and several members of the Calvert Investment Group (CIG), Calvert's angel investor network, also contributed capital to Oncoceutics under the same investment terms as Calvert Research.

"We are thrilled that Oncoceutics is now able to begin testing ONC201 in advanced cancer patients" said Dr. Michael A. Recny, President of Calvert Research. "The FDA's acceptance of the IND application underscores the success of our investment thesis, which focuses on working with early stage biopharmaceutical companies who rely on our expertise and investment capital to help them advance their promising experimental drugs into the clinic. We are also grateful to the members of CIG who co-invested in Oncoceutics alongside Calvert Research to help support this very exciting oncology compound."

Calvert Research, LLC
Calvert Research is a strategic advisory and equity investment firm with extensive knowledge covering all aspects related to advancing early stage drug candidates toward human clinical testing. We leverage our expertise by combining it with a wide range of preclinical services offered by our CRO affiliate, Calvert Laboratories to design and execute customized drug development investment partnerships with preclinical stage biopharmaceutical companies to reduce the capital requirements to complete their IND enabling animal studies (www.calvert-research.com). Contact: Dr. Michael A. Recny, EVP and Chief Investment Officer, Calvert Holdings, Inc. and President, Calvert Research, LLC (mrecny@calvertholdings.com; 919-459-8669).

Calvert Laboratories, Inc.
Calvert Labs provides a wide array of preclinical services to help clients navigate their GLP testing needs prior to advancing their discoveries into clinical trials. In addition to lead identification and lead optimization services, Calvert's core service offerings include toxicology, pharmacology, safety pharmacology, ADME, immunotoxicology and immunology. (www.calvertlabs.com).

Calvert Holdings, Inc.
Formed in 1996, Calvert Holdings, Inc. is a privately-held company that provides vision, resources and business leadership for all of the companies we develop or acquire. Calvert Holdings is currently the parent company of Calvert Labs and Calvert Research.


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Michael Recny
Calvert Research, LLC

Cary, NC
USA
Voice: 919-459-8669
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