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(Taiwan) PharmaEssentia announces commencement of Phase I clinical trial for its HBV/HCV drug candidate P1101 (PEG-P-IFN-alpha)
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(Press release, PharmaEssentia Corp.)
11 December, 2009
Taipei, Taiwan-based biopharmaceutical company PharmaEssentia Corp. today announced the initiation of a Phase I clinical trial for its innovative PEG chemistry rationale-designed hepatitis B and C drug candidate P1101 (PEG-P-IFN-alpha).
The Phase I trial is a randomized double-blind active control, single-dose escalation study in forty-eight healthy adult male volunteers being undertaken by Anapharm Inc. in Montreal, Canada under the guidance of Principle Investigator, Dr. Richard Larouche. The primary objective of the study is to determine the safety, tolerability, and pharmacokinetics of PEG-P-IFN-alpha in single ascending subcutaneous doses.
The results of the Phase I trial, scheduled to be completed by the middle of May, 2010, will determine the dosage and dose regimen for a planned Phase II clinical trail to be initiated by the end of 2010.
According to PharmaEssentia CEO, Dr Ko-Chung Lin, "P1101 appears to be a predominantly single positional isomer, in comparison to that of the leading marketed PEG-IFN products which consist of 8 to 14 positional isomers."
"Notably, the results of P1101 PK/PD studies in monkeys vs. currently marketed PEG-IFN products strongly suggested that a once every two or more weeks dosing regimen in man is anticipated when this trial is completed," he added.
About PharmaEssentia and the PEGylated technology platform:
PharmaEssentia Corporation is a biopharmaceutical development company, founded by a group of eminent Taiwanese-American scientists in August 2003, and headquartered in Taipei, Taiwan. Its mission is to discover, develop, and deliver to the market a range of efficacious, safe and cost-effective therapeutic products for human disease through new drug research and development.
In the field of protein drug design, the process of 'PEGylaltion' of the therapeutic protein preserves its biological activity by targeting the PEG polymer (polyethylene glycol) at a specific and defined region on the protein. PharmaEssentia's PEGylaltion Technology Platform is designed to increase the protein drug's effective size, slowing its circulation in the blood. Utilizing its innovative 40K PEG and its novel PEGylaltion technology platform of combining protein engineering and PEG-related chemistry, PharmaEssentia creates new products for better disease treatment. Compared with others on the market, the long-acting protein drugs produced by PharmaEssentia possess the most effective PK/PD data as well as least number of side-effects, as these PEG-proteins are designed as predominate single forms without other isomers which may induce severe side-effects.
About hepatitis B and C:
The hepatitis B and C viruses (HBV, HCV) are transmitted through blood-to-blood contact, causing acute and chronic liver disease, potentially leading to liver failure, cirrhosis and liver cancer. Worldwide, 350 million people are thought to be chronically infected with HBV, with an estimated 1 million deaths from the disease annually. A recent study revealed that the risk of liver failure, cancer or death following unsuccessful HCV treatment was 23 percent after 4 years, and 43 percent after 8 years. The leading reason for liver transplantation is previous hepatitis C infection.
Current HCV treatment method:
The current standard of care for HCV involves weekly injections for 48 weeks with PEGylated Interferon alpha together with oral administration of ribavirin. The response rate for the most common form of HCV in the United States to standard treatment is approximately 50 percent. The majority of patients treated with Interferon alpha products develop side effects early in therapy that include fever, chills and flu-like symptoms, as well as hematopoietic side effects such as neutropenia, thrombocytopenia, and leukopenia. Later side effects may include fatigue, irritability and depression. As a result of side effects, a reduction in Interferon alpha dosage is required in 10 to 40 percent of patients and, for 5 to 15 percent, treatment is discontinued. For those who continue therapy, additional supportive medications and treatments are often needed, increasing the overall cost of therapy for patients, doctors, and insurance companies. Without effective intervention, the National Institutes of Health project that the number of deaths from chronic HCV infection may triple in the next 10-20 years.
Potential market size and PharmaEssentia's new treatment development:
One of the most important advances in the treatment of hepatitis C has been the development of PEGylated interferons. PEGylated forms of a specific interferon, termed PEG-interferon alpha 2b, are FDA-approved products for the treatment of hepatitis C. We are developing a longer-acting PEGylated form of interferon alpha 2b which we have named P1101. A PEGylated interferon preparation has to be injected only once a week, versus three times each week for an un-PEGylated interferon product, and since it provides continued therapeutic levels of interferon in the blood, it leads to more potent antiviral action. Our cost-efficient manufacturing process will benefit patients and the overall healthcare environment both economically and clinically.
Contact:
PharmaEssentia Corp.
13F, No. 3 YuanQu St., Nankang District
Taipei 115, Taiwan
Tel: 886 2 2655 7688
Fax: 886 2 2655 7626
www.pharmaessentia.com
Ms. Shu-Fen Li, MBA
Director of Business Development and Strategic Planning
Ph: +886-2-2655-7688 ext. 7812
shufen_li@pharmaessentia.com
For editors:
PEG-P-IFN-alpha = PEG-P-IFN-α
IFN-beta = IFNβ
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Taiwan Life Sciences Weekly
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