VRGN - Viragen's CTX Approved
Human Clinical Trials to Commence
PLANTATION, Fla., July 29 /PRNewswire/ -- Viragen, Inc. (OTC Bulletin Board: VRGN - news) and Viragen Europe Ltd. (OTC Bulletin Board: VERP - news) announced today that the Medicines Control Agency, the governmental body that regulates therapeutic drugs in the United Kingdom, has approved Viragen's Application for a Clinical Trial Exemption (CTX) to commence human clinical trials of Omniferon(TM), Viragen's lead drug, for the treatment of Hepatitis C. The CTX Application was filed in association with the Scottish National Blood Transfusion Service (SNBTS), the official transfusion agency of Scotland, with whom Viragen has a collaborative partnership in the U.K.
Omniferon is a highly purified, multi-subtype natural interferon alpha derived from human leukocytes (white blood cells). Interferons are the proteins produced by the leukocytes that modulate the human immune system and are one of the body's most basic and effective defenses against a wide spectrum of diseases. The therapeutic importance and versatility of interferon is evidenced by the fact that various forms of interferon are approved to treat multiple diseases. The global sales of interferons are growing annually at a double-digit rate and are approaching $3 billion annually. Interferons are most commonly used for the treatment of hepatitis B & C, multiple sclerosis and certain cancers. Interferon was discovered more than 40 years ago. To date, a cost-effective manufacturing process to make human white blood cell-derived natural interferon eluded the entire pharmaceutical industry. Recombinant (synthetic) forms of interferon have dominated the market since their introduction in the mid-1980s. Viragen's top research talent developed the most advanced process manufacturing technology to make Omniferon on a cost-effective basis.
Gerald Smith, Chairman and CEO, stated, ''The official regulatory approval of the CTX Application marks one of Viragen's most important events. The growing public awareness of the grave health risks posed by hepatitis C, which has reached epidemic proportions worldwide, underlines the need for alternate therapies. Viragen believes that the inherent potential benefits of a naturally derived interferon will provide an important additional therapy to patients suffering from hepatitis C as well as a variety of other life- threatening diseases.''
''The most widely used and approved drug regimens to treat hepatitis C in the United States are recombinantly (synthetically) engineered interferon alpha based therapies. Medical literature suggests that these regimens ultimately benefit less than half of the affected patients. The fact that many patients simply cannot tolerate the side effects associated with recombinant interferon treatment is well documented in the medical literature.''
Natural interferon produced in the human body is not a single protein, but rather a collection of distinct proteins believed to interfere with viral infection to some degree. Collectively, interferons might be said to work as a ''cocktail-in-one'' drug. It is generally believed that the genes in the white blood cells produce up to 13 distinct primary alpha interferon subtypes to combat disease in the human body. Conversely, nearly all of the recombinantly (synthetically) engineered interferon drugs that currently dominate the multi-billion dollar interferon market only contain one primary interferon subtype. Viragen believes that synthetic alpha interferons are a particularly poor surrogate for the alpha interferon naturally produced by the human body.
Dr. Robert Perry, Director of the Scottish National Blood Transfusion Service, stated, ''We are proud to be associated with Viragen in their development of Omniferon. Blood collection agencies and pharmaceutical companies around the world have tried for years to develop a robust and cost- effective process to exploit the therapeutic potential of human leukocyte- derived interferon. The approval of Viragen's CTX is evidence of the substantial progress made in developing such a process. We believe that Omniferon could be a very important drug to treat a variety of life- threatening diseases.''
Dr. Magnus Nicolson, Chief Operating Officer of Viragen Inc. and Managing Director of Viragen Scotland Ltd.'s Edinburgh Manufacturing facility, stated, ''We have always believed that natural interferon had significant therapeutic potential for a large number of medical indications. The prohibitive historical manufacturing costs had formerly limited its commercial development by other drug companies. Our goal was to make natural interferon cost- effective. Viragen's research efforts had to solve many complex process- related issues at a much earlier stage in the development process than what is typical. Consequently, Viragen believes it can scale-up to large volume manufacturing of Omniferon once the clinical trials have been completed. The approval of the CTX to proceed with the Phase II clinical trial is a most important milestone to getting Omniferon approved and available for patient therapy.''
Patrick Yeramian, M.D., Viragen's Chief Medical Officer, said, ''The approval of our CTX Application enables us to start administration of Omniferon to patients with chronic hepatitis C. The Phase II study is designed to be a multicenter clinical trial executed in various European countries in patients with hepatitis C. The clinical trial will focus on demonstrating the efficacy, safety and tolerance of different doses of Omniferon in comparison to a recombinant interferon control.''
Hepatitis C is a chronic viral infection that afflicts more than 4 million Americans and about 5 million Europeans. There is currently no effective cure for hepatitis C, but synthetic interferon regimens alone or in combination with other drugs are the current standard of care for hepatitis C in both the United States and Europe. Omniferon is targeted to treat patients who cannot tolerate the recombinant therapy or who have failed on the recombinant regimen. This target market represents about 38% of all hepatitis C treated patients. Viragen's clinical strategy postures Omniferon as a second line, alternate therapy.
Mel Rothberg, Executive Vice President, commented, ''The data compiled to support the CTX Application provides Viragen with the requisite platform to follow on with our strategic alliances such as with AGC (Pakistan and Dubai) and Drogsan Healthcare (Turkey). These marketing partners are ready to file applications in those areas in which they have secured distribution rights to Omniferon. This includes Pakistan, India, Turkey and other Middle Eastern markets.''
''Viragen will now simultaneously vigorously pursue the development of Omniferon for certain promising anti cancer regimens alone or in combination with the new powerful therapeutic tools of human monoclonal antibodies.''
Viragen, Inc. and Viragen (Europe) Ltd. are emerging biopharmaceutical companies engaged in the research, development, manufacture and clinical study of blood-derived therapeutic drugs, including natural human interferon, for the treatment of various diseases and immune disorders, including hepatitis B and C, rheumatoid arthritis, multiple sclerosis, HIV/AIDS, chronic myelogenous leukemia and herpes. This release contains forward-looking statements that are subject to risks and uncertainties, including, but not limited to, certain delays beyond the companies' control with respect to future business events, regulatory approvals and other risks detailed from time to time in the companies filings with the Securities and Exchange Commission.
For more information please visit their web site at: viragen.com . |
