Applied Immune Sciences Inc. (AIS) reached a milestoneWednesday that will result in an equity investment to the companyof at least $21 million.The Santa Clara, Calif., company received approval for a Phase I/IIclinical trial to evaluate the safety and effectiveness of its AISCELLector CD5/CD8 device for purging T and B cells fromallogenic bone marrow in matched related bone marrow transplantpatients. The approval triggered a milestone in which AppliedImmune Sciences (AIS) will sell Rhone-Poulenc Rorer (RPR) 1million newly issued shares of stock at $21 per share, if exercised inthe first quarter of 1995, with increases of 50 cents per share eachquarter thereafter up to $25 per share.Jackie Cossmon, AIS' director, corporate communications, toldBioWorld the company had about $22 million in cash on Sept. 30and is burning about $30 million per year. So, she said, the stock isexpected to be sold to Rhone-Poulenc in 1995.Rhone-Poulenc, of Collegeville, Pa., a subsidiary of France-basedRhone-Poulenc Group, invested $113 million in AIS in September1993 by buying about 4.3 million of AIS' 10.48 million sharesoutstanding. The new investment will bring Rhone-Poulenc's stakein AIS to 42 percent. Approval of a Phase I trial for a separateCELLector product would result in another milestone with the sameterms, and give RPR a 47 percent stake in AIS.AIS' stock (NASADAQ:AISX) was up 38 cents Wednesday,closing at $5.50 per share."The milestone has significance in a couple of ways," Cossmonsaid. "One, it really positions us to have cash available to fund ourcontinuing operations. Secondly, it puts forth our commitment toour strategic alliance with RPR, and we have met the first in a seriesof goals in order to enable them to purchase more of the company."The Phase I/II trial was approved by the FDA under aninvestigational device exemption. Matthew Carabasi, of theUniversity of Alabama, will serve as principal investigator.Cossmon said the trial will involve removing T and B cells frombone marrow and injecting them back into the patient to make surethe bone marrow put back is depleted of the cells. Studies haveshown, she said, that T cell depletion may be related to reducedincidence of graft-versus-host disease. That trial incorporates thecompany's CELLector soybean agglutinin (SBA) device.The CELLector technology can be used for a number of therapiesdepending on the monoclonal antibody manufactured in the device.AIS has two CELLector products awaiting FDA approval for PhaseIII trials. One, which involves CELLector CD5/CD8 by itself, is forallogenic bone marrow transplant patients. Pending approval, theendpoints would be reduction in graft-versus-host disease andincreased time to engraftment, Cossmon said.The second proposed trial, using AIS CELLector CD8, is in renalcell carcinoma. The trial would involve removing immune cellsfrom the tumor, expanding them through interleukin 2 and growthmedia, and then reinfusing them into the patient. The companywould be looking for improved response rate to the renal cellcarcinoma.AIS also has a CELLector CD8 product in trials. It currently isanalyzing interim results of a Phase II trial in HIV patients. n
-- Jim Shrine
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