Shaman Pharmaceuticals Inc. announced Wednesday that it hasreceived two key patents from the U.S. Patent and TrademarkOffice.
Patent No. 5,211,944, issued last week, describes thecomposition of matter and method of use for SP-303, theactive ingredient in two of the company's anti-viralcompounds. The other patent, No. 5,202,348, which issued inApril, describes the composition of matter and/or method ofuse for Shaman's SP-1100 series of anti-fungal compounds.
Shaman's (NASDAQ:SHMN) anti-viral compound SP-303 isderived from a medicinal plant. The company started clinicaltrials on this agent -- trade-named Provir -- for treatingrespiratory syncytial virus infections (RSV) in October 1991.
According to Shari Annes, senior director of corporatecommunications and investor relations, Shaman of South SanFrancisco, Calif., began a Phase II challenge study in healthyadult men last month. The volunteers are infected with RSVand then treated with the drug, an oral formulation. Shaman isplanning a Phase II study of Provir in RSV-infected childrenduring the upcoming late 1993 to 1994 flu season.
For use as a topical treatment for herpes simplex 1 and 2, SP-303's moniker is Virend. Virend is currently in a Phase I/IItrial in acyclovir-resistant AIDS patients with herpesinfections. Patient enrollment for that trial -- begun inJanuary -- is ongoing.
Annes told BioWorld that Shaman also hopes to start trialsthis fall on non-acyclovir-resistant AIDS patients withsecondary herpes infections. That trial will require anamendment to Shaman's investigational new drug (IND)application for Virend.
The Italian company Inverni della Beffa entered into a long-term agreement with Shaman in October 1991 to manufactureSP-303. Inverni also has the non-exclusive marketing rights inItaly to SP-303.
Shaman's other class of compounds now covered by a patent --the SP-1100 series -- is anti-fungals. An agent is currently inlate preclinical development, and Shaman hopes to file an INDby the end of the year, Annes told BioWorld. SP-1100 isspecifically not covered in the joint development agreementthat Shaman reached with Eli Lilly and Co. in October 1992 onplant extracts for treating systemic fungal infections, sheadded.
Shaman's stock was up 25 cents a share on Wednesday, closingat $14.
-- Jennifer Van Brunt Senior Editor
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