By Frances Bishopp

With several new investors on board, apoptosis company Cell Pathways Inc. has raised $17.5 million in a private financing to expand the clinical trials of its lead product, FGN-1, bring forward a new product to the investigational new drug stage and relocate its operation to a new facility.

The privately held company, currently located in West Conshohocken, Pa., is renovating a 37,000-square-foot facility in Horsham, Pa., and expects to move into the new offices in July and the laboratories in October of this year.

Robert Towarnicki, president of Cell Pathways, said he hopes this will be the company's last private financing and that Cell Pathways will go public either later this year or early next year.

Participants in the Series F financing included new investors Goldman Sachs, of New York, New York Life, of New York, Gem Capital Management, of New York, Doerge Capital Management, of Chicago, and SenMed Ventures, of Cincinnati.

Former investors included Jackson Boulevard Partners, of Chicago, Northwood Ventures, of New York, Technology Partners, of Belvedere, Calif., and Vulcan Ventures, of Seattle.

FGN-1, a small molecule, is in Phase III clinical trials as preventive therapy for precancerous colon polyps in patients with adenomatous polyposis coli (APC), a disease which causes patients to form large numbers of colon polyps and subsequently face a high risk of colon cancer at an early age.

Cell Pathways, which has a burn rate of approximately $550,000 per month, plans to expand FGN-1's trial indications to include: sporadic colon polyp formation, cervical dysplasia and the prevention of tumor recurrence in prostate and breast cancer.

The trials are expanded to begin late this year, Towarnicki said.

The trials will target both precancerous cells and epithelial-derived cancers. "We have demonstrated effect in vivo and in vitro against most of those cell lines in preclinical studies for these four indications and others," Towarnicki said.

Phase II trial results of FGN-1 for APC provided the first direct evidence in humans that FGN-1 causes regression of precancerous colon polyps by selectively augmenting apoptosis (programmed cell death) in abnormally growing cells without affecting normal proliferating cells.

Preliminary six-month data from patients in the first two dose groups showed regression of small polyps in 11 of 12 patients. Larger polyps did not appear to be affected at the end of six months, although investigators saw none of the clinical worsening that normally appears in APC patients.

Investigators measured significantly higher rates of apoptosis in biopsies taken from regressed polyps compared to polyp biopsies taken prior to drug treatment.

Data demonstrated total elimination of new polyp development, Towarnicki said.

The new chemical entity on its way to the investigational new drug application stage also is a small molecule that works through a pathway, Towarnicki said, that initiates apoptosis in cells that are neoplastic (cells with a genetic defect that are either cancerous or on the way to being cancer).

"This is a much more potent compound," Towarnicki said, "in terms of initiating apoptosis in neoplastic cells."

Cell Pathways, which considers itself a pioneer in the field of "chemoprevention" (the development and commercialization of therapeutics that arrest and reverse premalignant lesions), has 26 employees. In addition to this financing, the company has raised a total of $14.5 million. Towarnicki expects the company burn rate this year to expand to approximately $900,000 a month. *