By Randall Osborne
Shaman Pharmaceuticals Inc. suspended a Phase II trial of Virend, its topical treatment for herpes in patients with AIDS, after an interim analysis showed the drug — when used in combination with oral acyclovir — showed no added benefit.
"We were looking for additional benefit from a marketing impact point of view, not just one day of improvement," said Lisa Conte, president and CEO of South San Francisco-based Shaman. "We wanted three days."
Those results did not materialize, although an earlier Phase II trial in AIDS patients with recurring herpes showed Virend alone worked better than a placebo. (See BioWorld Today, Oct. 26, 1995, p. 1.)
"This trial is over," Conte said, adding that the company will not test Virend in any other indications.
"We decided to save those resources and put them into our lead product," she said.
That product is Provir, which — like Virend — is based on an extract from croton, a Latin American plant. Unlike Virend, Provir is administered orally, and is used to treat AIDS-related diarrhea. Provir will move into Phase III trials this month, Conte said.
"We're looking forward to filing the new drug application within a year," she added.
In an earlier, 51-patient Phase II trial, Provir achieved statistical significance in two primary endpoints. (See BioWorld Today, Oct. 31, 1997, p. 1.)
Two other Phase II trials, studying Provir in moderate to severe diarrhea, are ongoing in Jamaica and Venezuela. Both will be completed this quarter, with results available at the start of the second quarter.
"We still have a full pipeline," Conte said.
An investigational new drug application recently was filed for nikkomycin Z, an oral antifungal for the treatment of systemic fungal infections. Another compound, SP-134101 for diabetes, entered Phase I trials last week.
The diabetes drug is one of 15 in Shaman's Type II diabetes program, which forms the basis for collaborations with Lipha SA, a wholly owned subsidiary of Merck KGaA, in Darmstadt, Germany, and with Ono Pharmaceuticals Inc., of Osaka, Japan.
Shaman uses what it calls an ethnobotanical approach to drug discovery, formulating pharmaceuticals from active ingredients in tropical plants and trees traditionally used as medicinal herbs in South America, Africa and Southeast Asia.
The company's stock (NASDAQ:SHMN) closed Friday at $4.625, down $0.312. *