National Editor

BioNumerik Pharmaceuticals Inc. is topping off 2003 with more than $35 million in cash, thanks to a $29 million private placement with existing investors.

Officials at the San Antonio-based company could not be reached for comment, but the company said in a press release the money will go for Phase III trials of its chemoprotecting agent Tavocept and to push clinical development of the cancer drug karenitecin BNP1350, currently in Phase II trials.

For Tavocept, designed to prevent or reduce the incidence or severity of paclitaxel-associated nerve damage, the FDA has granted BioNumerik fast-track status, and a multicenter pivotal U.S. Phase III study in metastatic breast cancer patients is under way to evaluate it compared with placebo in preventing or reducing paclitaxel-induced neurotoxicity.

Patient accrual was recently finished for a European Phase III trial of Tavocept with paclitaxel and cisplatin in patients with non-small-cell lung cancer, and a pivotal trial for Tavocept was begun in Japan in the second quarter of this year.

Karenitecin BNP1350, a highly lipophilic camptothecin, is the fourth-generation compound in its class and recently completed a Phase II trial in non-small-cell lung cancer patients. In June, privately held BioNumerik and The Cancer and Leukemia Group B at the University of Chicago presented data from the study, saying the rates of partial response plus stable disease and median survival were similar to other agents considered active. The drug is in other Phase II studies for brain tumors, melanoma and ovarian cancer.

Farther back in the pipeline is MDAM, a patented non-polyglutamylatable antifolate for solid tumors, rheumatoid arthritis, psoriasis and asthma. With a chemical structure similar to methotrexate, MDAM appears to bypass the common forms of antifolate-type drug resistance and in preclinical studies has demonstrated selective cancer cell uptake and superior dose intensity, safety and antitumor activity relative to methotrexate, the company said. Phase I trials for racemic MDAM have been completed.