Genelabs Technologies Inc. announced Monday that it has filedan investigational new drug (IND) application with FDA forclinical trials on its anti-cancer compound GL331 for treatingcancer patients whose tumors have become resistant tochemotherapeutic drugs.
More than 40 percent of patients with leukemia, lymphomaand many solid tumors suffer from multiple drug resistance.
GL331 is derived from the May apple and was synthesized in1988 by researchers at the University of North Carolina, ChapelHill, (UNC-CH) and Yale University School of Medicine. Genelabsand UNC-CH signed an exclusive licensing agreement lastJanuary to develop the compound as an anti-cancer product.
Genelabs (NASDAQ:GNLB) will develop GL331 for worldwidemarkets, make milestone payments to UNC-CH and payroyalties upon successful market launch. Genelabs and itspartner, Yung Shin Pharmaceutical Co. of Tachia, Taiwan, willmarket GL331 in Asia, except Japan.
The Redwood City, Calif., company is also developing GL331 asa first-line therapy for treating a variety of tumors. Genelabsoriginally was developing the compound for small cell lungcancer. In preclinical trials, the compound demonstratedactivity against malignant cells with multidrug resistance andalso reduced toxicity compared with etoposide, the currentdrug of choice.
"We plan to enter clinical trials in 1993 for use of GL331 asprimary therapy for lung cancers, germ cell tumors and as asecondary agent to treat non-Hodgkin's lymphomas andselected other tumors with multiple drug resistance," saidFrank Kung, Genelabs' president and chief executive officer.
-- Jennifer Van Brunt Senior Editor
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