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Celek Pharmaceuticals Receives National Cancer Institute Award to Develop CEL-031 for the Treatment of Bladder Cancer

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Celek Pharmaceuticals announced that the National Cancer Institute (NCI) has awarded the Company a Phase I Small Business Innovation Research (SBIR) Contract to support development of CEL-031, Celek’s targeted, first-in-class oncology drug candidate for the treatment of bladder cancer.

Celek was selected for this $176,266 award based on a competitive review following NCI’s request for proposals on the development of novel anticancer agents. CEL-031 is a small molecule compound that selectively induces apoptosis, or programmed cell death, in cancer cells by targeting phosphodiesterase enzymes, which are overexpressed in human tumor cells. The drug candidate showed evidence of efficacy and a favorable safety profile in earlier clinical studies as an oral treatment for several advanced cancers. In this setting, however, CEL-031’s efficacy was limited by the compound’s oral bioavailability. Celek plans to maximize CEL-031’s commercial potential by developing it for non-muscle invasive bladder cancer (NMIBC), where the compound will be instilled directly into the bladder by catheter, the standard route for delivering drugs to treat this disease. There is a significant need for safer and more effective NMIBC treatments that can prevent recurrence and progression of this cancer.

Celek and its collaborators, Drs. Seth Lerner and Jonathan Levitt in the Scott Department of Urology at Baylor College of Medicine, recently completed a pilot study of CEL-031 in an animal model of NMIBC. In this study, mice with bladder cancer tumors were treated twice over a three-week period with CEL-031 at two dose levels, while control animals were treated with the formulation vehicle alone. At the end of the treatment period, the average tumor size in both groups of CEL-031-treated animals was reduced by approximately 50% compared to the control mice. In addition, twice as many animals survived through 3 weeks in the CEL-031-treated groups compared to the control group. These results from a small pilot study support CEL-031’s potential as an effective, targeted therapy for NMIBC. During the Phase I SBIR project period, Celek will build on these results by further optimizing the CEL-031 formulation and testing the drug’s efficacy in a larger study using the NMIBC animal model.

Dr. Lerner, who holds the Beth and Dave Swalm Chair in Urologic Oncology at Baylor College of Medicine, said: “There is a pressing need for more effective treatments for non-muscle invasive bladder cancer. The results of the pilot study are very encouraging and we look forward to testing this compound further under the NCI SBIR contract, with the goal of moving it towards a proof-of-concept clinical trial in bladder cancer patients.”