Calvert Research and Oncoceutics Announce Investment Partnership to Advance ONC201 to an IND Filing

    RALEIGH, NC, October 01, 2013 /24-7PressRelease/ -- Calvert Research, LLC, a business unit of Calvert Holdings, Inc., and Oncoceutics, Inc. today announced the execution of an Investment Partnership Agreement to support the completion of preclinical development studies for ONC201, Oncoceutics' preclinical stage experimental anti-cancer compound.

Under the terms of the Agreement, Calvert Research will utilize the extensive resources of its CRO affiliate, Calvert Laboratories, Inc., to complete animal pharmacology, toxicology, and pharmacokinetic testing and conduct bioanalytical studies on ONC201 to support the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration by the end of 2013. In conjunction with performing these studies, Calvert Research has made a significant investment in Oncoceutics in the form of a Convertible Promissory Note that can be converted into equity in Oncoceutics under certain terms and conditions.

ONC201 is a small molecule that has shown potent anti-tumor effects in multiple mouse models of human cancer, including brain, colon, breast, lung, and other tumors. ONC201 elevates the expression of TRAIL (TNF-related apoptosis-inducing ligand) and its death receptor DR5 on the surface of tumor cells to trigger a tumor-specific cytotoxic response. ONC201's exclusive ability to stimulate expression of both the death receptor and TRAIL leads to an increased spectrum of anti-tumor activity, which may offer a meaningful therapeutic benefit to cancer patients in numerous clinical settings.

"We are very pleased to add Oncoceutics to our investment portfolio," said Dr. Michael A. Recny, President of Calvert Research. "This deal represents another outstanding example of how we implement our investment thesis by identifying opportunities to share both the capital risk, and the development risk with early stage companies that have novel, highly promising experimental drugs. Our partners benefit from not only our extensive drug development expertise, but also our ability to leverage the world-class capabilities of our affiliate, Calvert Laboratories into a meaningful capital investment in their company."

"We are delighted that Calvert invested in Oncoceutics to help us advance ONC201 toward human testing," remarked Dr. Wolfgang Oster, CEO of Oncoceutics, Inc.. "This investment partnership is indicative of Calvert's entrepreneurial spirit as well as our aligned interests, and it validates the compelling data with ONC201 that have already been generated."

About Oncoceutics, Inc.

Oncoceutics, Inc. is a drug discovery and development company, run by a leadership team with an outstanding track record of success in drug development that seeks to develop and commercialize novel anti-cancer therapeutics. The company investigates small molecule compounds to overcome dysfunctional p53 and related pathways, the most frequently mutated in human cancers. The most advanced of these molecules, ONC201, is the subject of a $1.3 million grant from the Pennsylvania Department of Health that will be used to complete the preclinical and administrative components of an IND application, obtain IND and IRB clinical protocol approval, and conduct the first Phase I/II trial in humans. Oncoceutics is on track to file an IND application by the end of 2013 seeking approval from the FDA to begin human clinical studies with ONC201.

Contact: Lee Schalop, Chief Business Officer ([email protected])

About Calvert Research, LLC

Calvert Research is a strategic advisory and equity investment firm located in the Research Triangle Park area of North Carolina. Our extensive knowledge base and experience covers all aspects related to advancing early stage drug candidates toward human clinical testing such as drug manufacturing, drug product formulation, analytical/bioanalytical methods development and animal safety, toxicology, pharmacology, immunology and pharmacokinetic 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 required to complete IND enabling animal safety and pharmacology studies (www.calvert-research.com).

About Calvert Laboratories, Inc.

Founded in the 1970's as a global service provider, Calvert Labs' core offerings include toxicology (acute through chronic & carcinogenicity plus reproductive and developmental), pharmacokinetics & ADME, pharmacology, safety pharmacology, immunotoxicology and immunology. Calvert Labs has an impeccable regulatory track record; never in its 40 year history has a study been rejected by any international government health service regulatory body for design or conduct. In addition to lead identification and lead optimization services, Calvert Labs provides a wide array of preclinical services to help our clients navigate their GLP testing needs prior to advancing their discoveries into clinical trials (www.calvertlabs.com).

About Calvert Holdings, Inc.

Formed in 1996, Calvert Holdings, Inc. (www.calvertholdings.com) 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 Laboratories, Inc. and Calvert Research, LLC.

Contact:

Dr. Michael A. Recny
Executive V.P. and Chief Investment Officer, Calvert Holdings, Inc.
President, Calvert Research, LLC
(919) 459-8669
email: [email protected]

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