Sidney Pestka, M.D., Wins Sixteenth Annual Warren Alpert Foundation Prize

PISCATAWAY, N.J., June 9 /PRNewswire/ -- Sidney Pestka, M.D., whose pioneering research made interferon therapy for hepatitis C and other viral diseases a reality, was named yesterday with two others as winner of the sixteenth annual Warren Alpert Foundation Scientific Prize.

The Foundation recognizes Dr. Pestka, Chairman and Chief Scientific Officer of PBL Biomedical Laboratories, for his seminal accomplishments in purifying, characterizing and cloning human interferon-alpha, or Hu-IFN-alpha, a virus-fighting substance produced by white blood cells. David V. Goeddel, Ph.D., founder and Chief Executive Officer of Tularik, Inc., and Charles Weissmann, M.D., Ph.D., the Institute of Neurology, University College London and Director of the Department of Infectology, Scripps Florida Research Institute, share the prize for crucial work in which they cloned Hu-IFN-alpha in the bacterium E. coli and demonstrated that biologically active interferon could be produced in large enough quantities to make it a practical treatment for disease. The Foundation will divide among the winners a $150,000 award.

Interferon-alpha is the key component of the only known treatment regimen for hepatitis C, a viral disease of the liver spread by exposure to the blood of those already infected. Approximately 170 million persons suffer from chronic hepatitis C infection worldwide, and two to three million new cases are diagnosed each year. If untreated, chronic hepatitis C can lead to cirrhosis, and infection raises the risk of liver cancer 100-fold. But using a combined regimen of pegylated interferon-alpha and ribavirin, doctors now cure about 50 to 80 percent (depending on the viral strain) of chronically infected hepatitis patients, heading off permanent liver damage and cancer.

Interferon-alpha is used to treat several other viral diseases, including hepatitis B and human papillomavirus, or HPV, the most common sexually transmitted disease in the United States and the cause of most cervical cancer. Interferon is also used in the treatment of cancer. It has been shown to be effective in various forms of leukemia and in Kaposi's sarcoma, a cancer associated with HIV infection.

Scientists had noticed during the 1930s that viruses tend to strike one at a time. It is quite rare, for example, for a child to have measles and chickenpox simultaneously. Researchers explained this phenomenon by way of a theory of "viral interference," which proposed that cells exposed to a virus release some agent that protects the body from infection by other viruses. In 1957, scientists in London discovered a highly potent protein that played just such a protective role after viral infection, and they accordingly named it interferon.

The discovery of interferon, a natural cell product that acts against a wide range of viruses by protecting cells from infection and stimulating the immune system, was greeted with great excitement, and its clinical future seemed bright. However, cells produce interferon in miniscule amounts, and two decades' worth of attempts to purify and characterize the protein met with repeated failure.

Pestka first found he could greatly increase the interferon yield in his experiments by using white blood cells from leukemia patients, and then, after developing a new technique-reverse-phase high-performance liquid chromatography, now used in biological laboratories throughout the world-he successfully purified ten unique interferon-alpha proteins in 1978.

Pestka's later collaborative work with Weissman (then at the University of Zurich) and Goeddel (then at Genentech) then led to the production, in bacteria, of as much human interferon-alpha per liter as could be made from the white blood cells of 100 donors. Moreover, the protein created in these experiments was potent enough to protect monkeys from otherwise deadly viral infections.

The translation of this research from the laboratory to the clinic was remarkably rapid. Recombinant interferon-alpha was first injected into a human patient in 1981, and the drug received FDA approval for the treatment of leukemia just five years later. Today, millions of patients throughout the world have received interferon-alpha for many conditions that were previously untreatable, and other potential uses for interferon continue to be explored in clinical trials and in basic research.

The Warren Alpert Foundation Scientific Prize

The Warren Alpert Foundation Scientific Prize is given each year for far- reaching scientific breakthroughs that have had a direct impact on the treatment of disease. Each year the Foundation receives 30 to 50 nominations for the Alpert Prize from scientific leaders worldwide. Prize recipients are selected by the Foundation's scientific advisory board, made up of internationally recognized biomedical scientists. See http://www.hms.harvard.edu/fa/AlpertPrize/ for more information.

PBL Therapeutics

PBL Therapeutics is producing the next generation of interferon molecules -- Ultra Interferons(TM), which can be 20 to 30 times more potent than the interferons currently used in therapy. Equally significant, PBL Therapeutics has also developed its Sustained Release Protein Delivery (SuRe-PD(TM)) technology to deliver interferon directly to tumors and release the drug slowly over time. Together, Ultra Interferons(TM) and SuRe-PD(TM) are expected to enable PBL to develop more effective cancer treatments, with dramatically reduced side effects.

PBL Therapeutics, an emerging biotechnology company, has developed three technology platforms: (1) Using its drug discovery platform, PBL can identify a virtually unlimited number of interferon variants that are produced naturally in cancer cells. Selected variants under development are 20 to 30 times more effective than Alpha 2 interferon, the first and only interferon approved for cancer therapy. The Company screens these molecules to determine which "Ultra Interferon(TM)" possesses the preferred characteristics to treat the diseases of choice. (2) PBL then formulates the Ultra Interferon. using its Sustained Release Protein Delivery ("SuRe-PD(TM)") technology to deliver the interferon locally, and release it slowly over time. Together, these two technology platforms enable PBL Therapeutics to develop the most promising interferon molecule, and to maximize the effectiveness of this molecule through extended-release, localized delivery. (3) PBL Therapeutics' phosphorylation technology, used primarily to radiolabel monoclonal antibodies (MAbs), significantly improves upon the chemical labeling procedures currently used to target radiation to tumors. MAbs with genetically engineered phosphorylation sites facilitate the delivery of high-energy radioactivity to cancer cells. Phosphorylated MAbs retain higher activity and selectivity for tumor antigens and appear less immunogenic than MAbs radiolabeled through conventional chemical conjugation methods. This technology complements the company's Ultra Interferons(TM), which stimulate expression of the tumor cell surface antigens that phosphorylated MAbs target.

Certain statements contained herein, including statements regarding development of the Company's products, services, markets, and future demands for the Company's products and services, and other statements regarding matters that are not historical facts, are forward-looking statements. Such forward-looking statements include risks and uncertainties; consequently, actual results may differ materially from those expressed or implied thereby.

Contact:

Robert Pestka, President & CEO, PBL Therapeutics, +1 (732) 777-9123

PBL Therapeutics

CONTACT: Robert Pestka, President & CEO of PBL Therapeutics, +1-732-777-9123

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