Colby is a clinical drug-development company located in Madison, WI & Menlo Park, CA. The company was launched as a Wisconsin Alumni Research Foundation (WARF) spin-out and is strategically aligned with leading clinicians and drug discovery scientists at the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center (UWCCC). Colby is accessing data from $15M in funded grants to develop its new class of small molecule Oxidative Stress Modulator (OSM) therapeutics. These drug molecules specifically target and therapeutically modulate the metabolic pathways producing pathophysiologies due to changes from cellular oxygen free radicals in Prostate Cancer (PCa) and Benign Prostatic Hyperplasia (BPH).
Colby’s lead drugs have unique mechanisms of action and target multiple Oxidative Stress (OS) generating-hormonal and -oxidase enzyme pathways in prostate disease. The Company is focused on clinical development of its lead drugs, CPC-100 and -200, in men with recurrent PCa, following surgery and radiation, but prior to detection of metastasis. In 2008, Colby will launch a Phase I/IIa study of CPC-100 in men with PCa who fail Androgen Depletion Therapy, as evidenced by rising PSA levels. In 2009 CPC-200 will enter Phase I/IIa in men with high-risk PCa and rising PSA, prior to Androgen Depletion Therapy. Colby’s two pipeline OSM drugs, CPC-300 and -410, are drugs for men with detectable metastatic PCa, at pre- and post-Chemotherapy stages, respectively, and are currently in pre-clinical development funded by federal grants. These two pipeline drugs were derived from Colby’s OS-ChemGen Platform Technology, which also identifies signaling and mitochondrial electron transport OS paths which can be modulated by small molecule therapeutic drugs.
Colby has exclusively in-licensed three OSM drugs from WARF in exchange for equity ownership. The company is leveraged to file four new Investigatory New Drug (IND) applications over the next four years and has identified drug development strategies in multi-billion dollar markets with significant unmet needs. Colby’s financing strategies provide clear routes to partnering or investor exits. Colby Pharmaceuticals is establishing renewable and sustainable revenue generation opportunities through contracts, partnering and out-licensing of its drugs and pipeline at quantifiable risk/value inflection points and from product sales.
The Company has demonstrated safety following toxicology studies in mice and rats, therapeutic proof of concept in the TRAMP (Transgenic Adenocarcinoma Mouse Prostate) mouse model of PCa, and on-going studies in dogs are being funded by grants. These studies will complete the necessary data package for filing Investigational New Drug (IND) applications with both CPC-100 (lead) and CPC-200 (co-lead) drugs.
Colby’s management team is lead by CEO David Zarling PhD MBA, previously CEO of Pangene Corp (PGC), a drug & target validation and services spin-out company from SRI International. CSO Hirak Basu PhD has expertise in Phase I/II Oncology drug development and was formerly Associate Director of Oncology Drug R&D at Slil Biomed Corp, where he brought two drugs into clinical trials. COO Mitchell Finer PhD has experience in therapeutic product development from pre-clinical through Phase III, was previously CEO of Intracell and Genteric as well as formerly the VP R&D at Aventis/Gencell and VP Research at Cell Genesys. CMO Minesh Mehta MD has successfully led international Phase I/II/III Clinical Oncology trials. Recently he was chief strategic clinical advisor for TomoTherapy (TTPY), which completed its IPO last year. Anne Vallerga MA PhD is Vice President Contracts & Grants and was an Institutional Review Board Manager at Stanford University Medical School. The Colby Scientific Advisory Board includes the world-renowned prostate cancer clinician, George Wilding MD, UWCCC; synthetic organic chemist, Richard Zare PhD, Stanford Chemistry Chairman; internationally acclaimed oncology expert, Hasan Mukhtar PhD, UWCCC; and the leading free radical biophysicist, Balaraman Kalyanaraman PhD, Medical College of WI, Milwaukee.
In summary, Colby has an experienced team, valuable clinical prostate drug candidates for multi-billion dollar markets with unmet medical needs. Colby is seeking funding which would enable Colby to complete two Phase I/IIa PCa clinical trials for its lead and co-lead drugs by the end of 2010, building significant shareholder value and enabling subsequent financings at significantly increased valuations.
