Robert Abbott, president and chief executive officer of ViageneInc., will announce Wednesday at the H&Q meeting that hiscompany has entered into a $9 million, three-year agreementwith Miles Inc. of Pittsburgh to develop a gene therapy productto treat hemophilia A.

Viagene, a privately held company based in San Diego, and thePharmaceutical Division of Miles, will collaborate onestablishing the feasibility of using retroviral vectors to treatdeficiencies in factor VIII, the clotting protein that is lacking inpatients with hemophilia A.

Viagene brings to the agreement its cell lines for packaging andproducing the retroviral vectors to be used to deliver into cellsthe factor VIII gene, which Miles has licensed from GenentechInc. (The gene forms the basis of the recombinant productKogenate, which is awaiting FDA marketing approval.)

Miles will carry out the clinical development and conduct "anytoxicology/pharmacology studies necessary for filing aninvestigational new drug application (IND). Miles will alsoconduct all trials and registration of the product," Abbott toldBioWorld. "In many respects it's Miles' product," he added.

Miles will provide up to $9 million in up-front payments,research support and milestone payments. Viagene will getworldwide manufacturing rights, while Miles receivesworldwide marketing rights.

Miles has been making products for hemophilia therapy since1974. "Gene therapy is a logical next step in our recombinantfactor VIII research," said Ralph Galustian, president of MilesBiological Products business unit.

"This agreement initiates Viagene's development activities inthe area of genetic diseases," said Abbott. But the company hasongoing projects in AIDS immunotherapeutics and in amelanoma vaccine.

Viagene's HIV-immunotherapeutic product, which is beingfunded through a partnership with Green Cross Corp. of Osaka,Japan, was unanimously approved by the FDA's VaccineAdvisory Committee last June.

The vaccine is custom-tailored to each patient. The individual'sfibroblasts are transfected in vitro with an HIV env gene in aretroviral expression vector. Once the transgenic cells areexpanded in culture, they will be re-injected into the patient.Viagene will most likely commence injecting those patients inthe second quarter 1993, Abbott said.

Viagene also submitted last month two gene therapy proposalsto be reviewed at the March Recombinant DNA Advisorymeeting, Abbott told BioWorld. One protocol -- part of theGreen Cross agreement -- involves administering the HIVtherapeutic product directly to patients. The other is for amelanoma immunotherapeutic, which is basically autologousgene therapy, Abbott said.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.