A year after completing its Series A financing, BiPar Sciences Inc. entered the clinic with its first product, BSI-201, a poly-adenyl-ribose polymerase (PARP) inhibitor aimed at treating cancer.

It’s a target "that’s been known for quite a long time," said Tom White, president and CEO of the San Francisco-based company, "and a lot of companies have tried to develop molecules [against PARP] with limited success."

BiPar, founded in fall 2002 by White and six others from the University of California at San Francisco, gained its class of PARP inhibitors as part of an entire portfolio licensed from an undisclosed company, which already had conducted development work.

"That company had already spent about six years and $10 million," White said, "so it gave us a significant leg up in terms of a shortened development time."

BiPar recently started enrollment for its first trial with BSI-201. The open-label, dose-escalation study will involve between 18 and 34 advanced cancer patients and will be conducted at the M.D. Anderson Cancer Center in Houston, and at the Institute for Drug Development in San Antonio. It’s expected to finish up during the fourth quarter, with Phase II studies starting sometime in 2007.

BSI-201 is designed to work by inhibiting PARP, an enzyme that is up-regulated in nearly all tumor types and is critical to tumor survival. In preclinical testing, BSI-201 demonstrated activity against a number of tumor types, including ovarian, prostate, breast, colon, lung, pancreatic, cervical and bladder.

"So part of our task right now is to narrow down which paths are the best and most receptive" for further trials, White said.

BiPar also has a second PARP inhibitor getting ready to move into preclinical development. That compound, which acts using a slightly different mechanism than BSI-201, will be aimed specifically at treating pancreatic cancer.

Though in the field of cancer, PARP inhibitors generally have been developed to be used in combination with other therapies, frequently as chemosensitizers or radiosensitizers, BiPar is more interested in creating a monotherapy product.

"That doesn’t exclude combination [testing]," White told BioWorld Today. "But we’ve got a compound here that appears to have two mechanisms, both of which interfere with the growth of the cell."

Behind its PARP inhibitor program, BiPar is investigating iodothyronines, a class of compounds that have shown antitumor activity against multiple cancers, and have suggested promise in targeting mitochondrial metabolism, angiogenesis and tumor cytoskeleton. The company expects to file its first investigational drug application from this program by December.

White described BiPar’s structure as an "umbrella model," with a small group of senior executives managing outside consultants. The company has six full-time employees, but relies on a group of up to 23 workers, including consultants.

In November 2004, the firm closed its Series A round, raising $12.5 million. Before that financing, a couple of the founders, including White, "basically bootstrapped the company ourselves."

The company s investors to date include Seattle-based Vulcan Capital; Rowayton, Conn.-based Canaan Partners; Palo Alto, Calif.-based Asset Management Partners; Munich, Germany-based PolyTechnos Funds; and San Jose, Calif.-based Quantum Technology Partners.

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