By Jim Shrine
Data from a Phase II study of SuperGen Inc.¿s RFS 2000, published in a scientific journal, showed the second-generation topoisomerase inhibitor either shrank the pancreatic tumor or stabilized disease in 63 percent of patients.
There already are 120 patients enrolled in Phase III trials of RFS 2000, and the data were disclosed last year, but investors wanted to see them in a peer-reviewed journal, said Joseph Rubinfeld, president and CEO of San Ramon, Calif.-based SuperGen. Investors rewarded the company as the stock (NASDAQ:SUPG) gained almost 12 percent, or $1.312, Thursday to close at $12.375.
¿Two things people expected from us were peer-reviewed journals and a strategic alliance,¿ Rubinfeld said. ¿This is the first leg. In a sense, this makes the data that much stronger. The second leg hopefully will come shortly.¿
Right Deal¿ Could Mean U.S. Partnership
SuperGen plans to find a European partner for RFS 2000, and would partner the drug in the U.S., too, if the deal is right, Rubinfeld said. The drug is extracted from the bark and leaves of the camptotheca acuminata tree in China. Phase II results were published in the current International Journal of Oncology.
Phase II results in 60 evaluable patients showed 31.7 percent responded to treatment, 31.7 percent achieved stable disease and 36.6 percent of patients did not respond. Median survival time among responders was 18.7 months, which the company said was the longest reported for advanced pancreatic cancer patients.
The Phase III program includes studies comparing RFS 2000 to Indianapolis-based Eli Lilly and Co.¿s Gemzar in patients who have received no prior chemotherapy, and to 5-FU, a standard chemotherapeutic agent, in patients who have failed Gemzar treatment. Enrollment of about 500 patients in the studies is expected by the end of the year, Rubinfeld said. n