Interferon Sciences Acquires 43% of Metacine, a Developer of Dendritic Cell Cancer Vaccines.

Business Editors & Health/Medical Writers

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NEW BRUNSWICK, NJ--(BW HealthWire)--April 19, 2001

Technology Results From 10-year $25 Million Program At

The University Of Pittsburgh

Interferon Sciences, Inc. (ISI) (OTC-BB:IFSC) announced that it has exercised its option to acquire 43% of the common stock of closely-held Metacine, Inc., which develops anti-cancer vaccines based on dendritic cell technology. In addition, ISI received a five-year warrant to purchase an additional 9% of the shares of Metacine at an increased value.

Metacine's technology was developed during a 10-year, $25 million research effort by a team of six scientists at the University of Pittsburgh Medical Center led by Michael T. Lotze, MD, widely recognized as one of the world's leading experts and a pioneer in dendritic cell immunotherapy. Metacine has an exclusive license from the University of Pittsburgh for a portfolio of five issued patents, nine pending patents, and four invention disclosures resulting from this research.

University of Pittsburgh Chancellor Mark A. Nordenberg noted that Metacine's technology is a good example of Pitt's efforts to facilitate the commercial development of the research conducted at the University. "The University of Pittsburgh is the site of a great deal of pioneering research, much of it in the health sciences. We are committed to moving these scientific breakthroughs into the commercial arena where they can be used as the basis for products and technologies that will provide significant benefits and improve the quality of life for a wide range of people. These activities also contribute to our fulfilling the economic development role that has become an increasingly important part of our mission," Nordenberg said.

Due to the breadth of the dendritic cell program at the University of Pittsburgh, Metacine is investigating a number of different approaches to developing this therapy. A Phase I clinical trial is currently underway at the university for treatment of melanoma, the deadliest form of skin cancer. In this trial, dendritic cells (DC) isolated from the patient's blood are pulsed with multiple melanoma antigens (substances capable of inducing an immune response) to generate a "pulsed antigen" vaccine. The pulsed DC are then re-injected into the patient to stimulate the immune system to attack tumor cells that display these antigens. This trial follows an already completed 28 patient Phase I trial in which safety and immune response to the specific antigens used in the trial was demonstrated.

Several additional Phase I trials are currently being planned. These include an autologous vaccine trial, in which the patient's DC and tumor cells are removed, co-cultured, and reinjected to induce an immune reaction against the specific antigens displayed by each patient's tumor(s), a trial evaluating the intra-tumoral injection of DC engineered to express cytokines (hormone-like proteins which can regulate the immune response) at the tumor site, and a trial utilizing a novel method for stimulating DC directly in the patient (in vivo).

To date, a general lack of significant side effects in human clinical trials has been observed by Metacine, and by others investigating DC-based therapy. In animal studies using multiple groups of four-five mice in each experiment, Metacine's different DC immunization techniques exhibited results that included tumor regression typically exceeding 50% of initial volume and in numerous cases complete disappearance of tumor, regression of tumor volume at metastatic sites, protection against challenge with tumor cells subsequent to DC administration, and increased survival of treated animals to 60 - 90 days. In contrast, all untreated control animals died within 20 - 30 days.

James W. Sharpe, President and CEO of Metacine said, "We are pleased with Interferon Sciences' decision to proceed with this transaction. Metacine's ability to accelerate the development of new biological therapies based on our novel and highly promising DC technology will be greatly enhanced. Our clinical, manufacturing and regulatory programs will be strengthened by the experience and expertise ISI will be able to contribute to Metacine as the company develops."

Lawrence M. Gordon, Chief Executive Officer of ISI, stated, "Based upon the information provided to us from an independent third party review of Metacine's intellectual property, we are excited about Metacine's prospects. We look forward to taking an active roll in assisting Metacine as it seeks to capitalize on its technology."

Mr. Gordon further stated, "This is the first step in our previously announced plan to utilize our existing infrastructure and expertise to expand our portfolio of products and technologies. In addition, we plan to investigate potential therapeutic synergies between our multi-species natural alpha interferon and Metacine's dendritic cell technology."

While Metacine and its scientific founders at the University of Pittsburgh are currently testing common antigen pulsed DC-based vaccines similar to those being developed by other companies, Metacine has also developed novel technology that differs from that of others in the field. In particular, Metacine utilizes the patient's own antigens as opposed to "off the shelf" antigens to stimulate immunodestruction of cancer cells. Using its autologous vaccine and direct intratumoral injection approaches, Metacine has the potential to produce multivalent vaccines specific to each patient's tumor. By also developing in vivo methods for stimulation of DC, Metacine is extending the basis of DC therapy beyond that typically used by other companies.

About Metacine, Inc.

Metacine is a biopharmaceutical company dedicated to the use of biological therapy for the treatment of cancer, viral and auto-immune diseases, and for the prevention of organ transplant rejection. The Company specializes in the use of dendritic cells to modulate the body's immune response to: (1) cancer and chronic viral disease through immunostimulation, and (2) auto-immune disease and organ transplant rejection through downregulation of the immune system.

Metacine is pursuing four different approaches to the therapeutic use of DC for the treatment of cancer: (1) ex vivo (outside the body) cell processing using patient's DC pulsed with antigens, (2) ex vivo cell processing using patient's DC cultured with patient's tumor cells to create multi-antigenic, patient specific, autologous vaccines, (3) in vivo activation of DC to stimulate the patient's immune system to attack the primary tumor as well as metastatic sites, and (4) direct intratumoral injection of patient's DC engineered to produce the desired cytokine(s) at the tumor site in order to provoke an anti-tumor response in vivo. The use of DC as the gene delivery vehicle has a further advantage in that following injection the DC will migrate to the lymph nodes where they present the multiple antigens they have absorbed at the tumor site. Animal experimentation has shown that this technique has the potential to stimulate the patient's immune system to attack the primary tumor as well as any metastatic sites.

Metacine's program for prevention of organ transplant rejection represents another important area of application for DC. Ex vivo culturing and re-introduction of tolerogenic DC down-regulates the patient's immune system by flooding the system with DC that do not present the transplanted organ's antigens. Pre-clinical animal (mouse) models in which tolerogenic DC are introduced to prevent rejection of transplanted tissue have shown highly positive results as evidenced by a reduction of detrimental host-versus-graft immune responses resulting in a significant extension of life following organ transplant.

About the University of Pittsburgh

The University of Pittsburgh is one of the nation's leading research universities, garnering sponsored research support of nearly $400 million annually. Renowned for pioneering medical research ranging from the discovery of the polio vaccine to advances in transplant surgery, Pitt consistently ranks among the top ten universities in the country in terms of research support from the National Institutes of Health.

About Interferon Sciences, Inc.

Interferon Sciences, Inc. is a biopharmaceutical company engaged in the study, manufacture and sale of pharmaceutical products based on its highly purified, natural-source, multi-species alpha interferon. The Company's ALFERON N Injection(R) (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, including cancer and multiple sclerosis.

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, those risks and uncertainties detailed in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission.

Interferon Sciences, Inc...Advancing immunotherapy naturally