Viagene Inc. announced Tuesday that it has filed a registrationstatement with the Securities and Exchange Commission for aproposed initial public offering of 2.5 million shares of commonstock at $11-13 per share.

The underwriters are being managed by The First Boston Corp.,Prudential Securities Inc. and Nomura Securities Inc.

Viagene of San Diego said it intends to use the net proceeds ofthe offering for research and development, working capital andother corporate purposes.

The gene therapy company has several drugs in advancedstages of development, but is "closest to the clinic" with its HIVtherapeutic, according to Robert Abbott, president and chiefexecutive officer. Viagene is developing two versions of thisdrug for treating AIDS: an "ex vivo" format and a direct-injection format.

The first HIV immunotherapeutic, which is being fundedthrough a partnership with Green Cross Corp. of Osaka, Japan,was unanimously approved by the FDA's Vaccine AdvisoryCommittee last June. The vaccine is custom-tailored to eachHIV-infected patient; the individual's fibroblasts aretransfected in vitro with an HIV env gene in a retroviralexpression vector. Once the transgenic cells are expanded inculture, they will be reinjected into the patient.

Viagene has enrolled those patients, and should be ready toinject them in the second quarter of this year, Abbott said. Headded that the company has submitted documents to have thehuman trial protocol for the second approach -- administeringthe HIV therapeutic directly via injection -- to the RecombinantDNA Advisory Committee (RAC) for possible review at itsMarch meeting. Abbott said the company hopes to file aninvestigational new drug (IND) application for the direct vectorproduct by the third quarter.

As well, Viagene hopes another of its gene therapy trials -- thisone for treating melanoma -- will be reviewed at the MarchRAC meeting. The company could be ready to file an IND onthat product by the second quarter.

Still in the research stages are a herpes simpleximmunotherapeutic and a gene therapy product for treatinghemophilia A, Abbott told BioWorld. The latter is now coveredunder Viagene's $9 million, three-year agreement with MilesInc. to establish the feasibility of using retroviral vectors totreat deficiencies in Factor VIII.

Viagene had about $5 million in the bank at the end of 1992,said R. Jefferson Works, vice president and chief financialofficer. It is also expecting a payment from Miles "in the nextfew months" and $8 million this year from Green Cross to fundthe HIV program, Works added.

-- Jennifer Van Brunt Senior Editor

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

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