GREENWOOD VILLAGE, Colo.
July 16, 2012
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company developing repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction and conducting clinical trials on its four lead drugs (Ampion
) announced today the advancement of NCE001, from its proprietary methylphenidate derivatives family of compounds, to preclinical development for the treatment of glioblastoma multiforme, renal cell carcinoma and inflammatory breast cancer following the granting of multiple composition of matter and use patents in the
Dr. David Bar-Or, Ampio's Chief Science Officer (CSO) explained the focus on this particular drug, "NCE001 activates a specific intracellular phosphatase largely involved in inflammation, angiogenesis and cell proliferation pathways and has demonstrated remarkable in vitro effects on aggressive cancer cells of these three lineages. We believe it may play an important role in treating these particularly aggressive cancers. Ampio has entered into a development agreement with Syngene International (
) to manufacture and conduct all preclinical stages of development of NCE001 all the way to an IND submission to the FDA. These three cancers do not have adequate treatment options so NCE001 may qualify for an accelerated approval path by regulatory agencies including the FDA."
, Ampio's CEO noted, "Our recent successful financing and our confidence that we will successfully out-license our more advanced drugs means we need to begin development of lead compounds to replace them. The pre-clinical demonstration of efficacy of NCE001, the accelerated approval process, the relative low cost of development through an IND and the strong composition of matter patents recently granted worldwide make this a prudent decision at this time."
FDA's Accelerated Approval Process:
FDA's accelerated approval regulations allow accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. From
December 11, 1992
July 1, 2010
, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in post-approval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8–12.6 years) and the mean time was 4.7 years, representing a substantial time-savings in terms of earlier availability of drugs to cancer patients.
About Syngene International:
Syngene is an internationally reputed contract research and manufacturing organization with multidisciplinary skills in chemistry and biology services. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized services to pharmaceutical and biotechnology majors, on a strong platform of confidentiality and intellectual property protection.