CEL-031 is in preclinical testing for the nonmuscle invasive form of the disease.

Celek Pharmaceuticals has obtained a Phase I SBIR contract from NCI to support development of CEL-031, a drug candidate for bladder cancer. Celek says that it has received $176,266.

CEL-031 is a small molecule compound that selectively induces apoptosis in cancer cells by targeting phosphodiesterase enzymes, which are overexpressed in human tumor cells, Celek explains. The drug candidate showed a favorable safety profile in 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 nonmuscle 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.

Celek and its collaborators, Seth Lerner, M.D., and Jonathan Levitt, Ph.D., in the Scott department of urology at Baylor College of Medicine, recently completed a study of CEL-031 in an animal model of NMIBC. 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 three weeks in the CEL-031-treated groups compared to the control group. During the Phase I SBIR project period, Celek will work to further optimize the CEL-031 formulation and test the drug’s efficacy in a larger study using the NMIBC animal model.

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