The first Phase II results from SangStat Medical Corp.'s Allotrap2702 showed statistically significant in vivo inhibition of cell-mediated toxicity, company officials reported Friday.
The inhibition of the those natural killer cells is a key marker thatcorrelates with prolongation of graft survival without the need forcontinuous immunosuppression, the company reported in Geneva,Switzerland, at the 2nd International Conference on New Trends inClinical and Experimental Immunosuppression.
The study, in Nantes, France, was a double-blind, randomized,controlled look at safety and pharmacokinetics. The effect on naturalkiller activity was a prospective endpoint since that was shown inpreclinical studies to be a key marker of efficacy. That activity mayserve as a surrogate endpoint in future studies, the company said.
Allotrap is a synthetic peptide derived from the sequence of thehuman leukocyte antigen molecule. It is being tested in a series ofongoing and planned Phase II studies. SangStat, of Menlo Park,Calif., often does its Phase I and II trials in Europe _ with an eyetoward later trials in the U.S. _ because of the time and costbenefits.
SangStat officials could not discuss the results because the companyis under registration for a 2 million share secondary offering.Underwriters Hambrecht & Quist LLC, of New York; MontgomerySecurities, of San Francisco; and New York-based Jefferies & Co.have an overallotment option on another 300,000 shares.
SangStat stock (NASDAQ:SANG) closed down 13 cents Friday at$15 per share. At that price the offering would gross $30 million.
The company on Dec. 31, 1995, reported $9.2 million in cash andequivalents and a net loss for the year of nearly $8.7 million. It hadabout 9.6 million shares outstanding.
On Feb. 11, 1996, the same day SangStat announced the proposedoffering, it reported development of a cyclosporine formulation itbelieves is potentially bioequivalent to the branded drug, for whichprotection on composition of matter patents expired last September.A generic cyclosporine would be important because it is the primaryimmunosuppressive drug used for chronic therapy in transplantrecipients, and because the worldwide market exceeds $1 billion peryear n.
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