AEGiS-PRn: Interferon Sciences Completes Phase 3 Trial of HIV-Positive Patients

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Interferon Sciences Completes Phase 3 Trial of HIV-Positive Patients

PR Newswire; Monday December 8, 1:44 pm EST

NEW BRUNSWICK, N.J., Dec. 8 /PRNewswire/ -- Interferon Sciences, Inc. (ISI) (Nasdaq: IFSC - news) announced today it has completed its Phase 3 clinical trial investigating the safety and efficacy of ALFERON N Injection(R) for the treatment of HIV-positive patients. "This is an important milestone for ISI," said Lawrence M. Gordon, Chief Executive Officer. "Over the next several months, the Company will collect the clinical data from 16 investigator sites, verify the computer database, evaluate the data for safety and efficacy, and prepare the clinical summary of this trial. If favorable results from the 24- week treatment phase are obtained, the Company anticipates seeking FDA approval of ALFERON N Injection for the treatment of HIV-positive patients near the end of the first quarter of 1998 and would expect FDA review to take six months or less."

This randomized, multi-center, double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of ALFERON N Injection for the treatment of HIV-positive patients, some of whom were taking other FDA- approved antiviral agents. Patients who satisfactorily completed this Phase 3 double-blind study were eligible to enroll in a separate open-label continuation study to evaluate the safety and efficacy of three different maintenance treatment regimens. Approximately 93% of these patients have elected to enter this continuation study, which is currently in progress.

The Company also has a Phase 3 clinical program which is a multi-center, randomized, controlled trial designed to evaluate the safety and efficacy of ALFERON N Injection in previously untreated patients infected with hepatitis C virus (HCV). The HCV trial consists of a 24-week treatment phase and 24-week follow-up. If the results at the end of follow-up are favorable, the Company intends to file for FDA approval of ALFERON N Injection for the treatment of HCV by the end of the third quarter of 1998. However, an interim analysis is scheduled by March 1998 on a certain number of patients who have then completed treatment and follow-up. If the results of this analysis demonstrate that ALFERON N Injection treatment has achieved the study endpoint at a very high level of statistical significance, the Company intends to file for FDA approval for the hepatitis C indication in the second quarter of 1998, while continuing the study.

Interferon Sciences, Inc. is a biopharmaceutical company engaged in the manufacture and sale of pharmaceutical products based on its highly purified, natural-source, multispecies alpha interferon. The Company's ALFERON N Injection (Interferon Alfa-n3) product has been approved by the United States Food and Drug Administration for the treatment of certain types of genital warts, and is being studied for potential use in other indications. The Company also has other natural-source alpha interferon formulations in various stages of development for the potential treatment of viral and immune system diseases.

Interferon Sciences' press releases are posted on the Company's website located at http://www.interferonsciences.com. They are also available by facsimile 24 hours per day at no charge by calling PR Newswire's Company News On-Call at 800-758-5804, ext. 445138.

The forward-looking statements contained herein reflect ISI management's current views with respect to future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in the forward- looking statements, all of which are difficult to predict and many of which are beyond the control of ISI, including, but not limited to, those risks and uncertainties detailed in ISI's periodic reports and registration statements filed with the Securities and Exchange Commission.

SOURCE: Interferon Sciences, Inc.

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