By Randall Osborne
Virus Research Institute Inc. (VRI) reported strongly positive results from a Phase II trial of its vaccine to prevent rotavirus, a severe illness that strikes infants.
"It's the last of the major pediatric diseases for which a vaccine is not available," said Barrie Ward, CEO of Cambridge, Mass.-based VRI.
Rotavirus is a group of viruses from the family Reoviridae. The disease, which is responsible for gastroenteritis in infants, causes potentially fatal acute diarrhea and dehydration. In the U.S., about 500,000 infants per year require medical treatment for it, and about 15 percent of those are hospitalized.
VRI's vaccine uses a live oral human rotavirus. In the Phase II study, involving 210 infants, 90 percent were protected and only a small number of patients developed low-grade fever after the first of two vaccine doses. None required medical treatment.
The first dose was given at 10 to 12 weeks of age, and the second about eight weeks later. Patients were followed throughout the winter and spring rotavirus season. Two patients in the vaccine group developed the disease, compared to 18 in the placebo group, for an overall efficacy of 89 percent.
Late last year, VRI entered a development collaboration for the vaccine with SmithKline Beecham plc, of London, under which the latter is paying undisclosed license fees, milestone payments and royalties. SmithKline gets worldwide marketing rights. (See BioWorld Today, Dec. 15, 1997, p. 1.)
"The license agreement is such that they handle development [from here]," Ward told BioWorld Today.
Phase III trials could begin as early as next year. "I would like to think that is what's going to happen," he added. "It's SmithKline's call."
In May, VRI said it had agreed to merge with T Cell Sciences, of Needham, Mass., in a stock swap valued at $150 million. The new company, to be called Avant Immunotherapeutics Inc., will be located in Needham, subject to shareholder approval of the deal on Aug. 21, Ward said. (See BioWorld Today, May 13, 1998, p. 1.)
VRI's stock (NASDAQ:VRII) closed Friday at $3.50, unchanged. *