NEW YORK, July 28 /PRNewswire/ -- Polyphenon Pharma, an emerging research-based pharmaceutical company, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to its botanical drug, Polyphenon E(R), for the treatment of chronic lymphocytic leukemia (CLL). A Phase II study is currently underway at the Mayo Clinic in Rochester, Minnesota where researchers are studying the effects of an oral daily dose of Polyphenon E in CLL patients.
"The FDA Orphan Drug Designation for Polyphenon E represents a significant milestone in the development of this drug," said Stig Ogata, Polyphenon Pharma's Chief Operating Officer. "Orphan drug status provides incentives that can help accelerate the development process of Polyphenon E as an oral treatment for patients with CLL. This in turn could lead to other potential development opportunities for this drug in the area of oncology."
The FDA grants Orphan Drug Designation to encourage biotechnology and pharmaceutical companies to develop products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 people in the United States. This designation will entitle Polyphenon Pharma to seven years of marketing exclusivity for the drug upon FDA approval.
Polyphenon E contains highly characterized catechins that are extracted from green tea leaves through a proprietary process. The primary catechin in Polyphenon E, epigallocatechin gallate (EGCG), has been shown to affect many processes in the body related to abnormal cellular activity that can lead to cancer. Preclinical studies indicate that the catechins present in Polyphenon E may have multiple methods of action.
Chronic Lymphocytic Leukemia (CLL) is a type of cancer of the blood and bone marrow that progresses more slowly than acute leukemia. It affects a group of white blood cells called lymphocytes, which typically fight infection. Each year, about 10,000 people in the United States are diagnosed with CLL.
About Polyphenon Pharma
Polyphenon Pharma is a privately held subsidiary of the Japanese company, Mitsui Norin Co., Ltd., which discovered and manufactures the botanical drug Polyphenon E. Headquartered in New York, NY, Polyphenon Pharma focuses on the clinical development of Polyphenon E across a broad spectrum of therapeutic areas in which it has potential activity, including infectious disease/virology, urology, neurology, and oncology. The Company's two-stage approach to pursuing the full potential of Polyphenon E is to use its own resources to advance drug candidates through Phase II clinical trials or proof-of-concept studies and then seek global pharmaceutical partners to complete late-stage development and commercialization in multiple countries. More information is available at http://www.polyphenon-pharma.com
This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. Such forward-looking statements include, without limitation, those regarding the development plans of the Company and the expected results of our development. We can provide no assurance that such development will proceed as currently anticipated or that the expected results of such development will be realized. We are subject to various risks, including the uncertainties of clinical trials, drug development and regulatory review, the early stage of our product candidates, our reliance on collaborative partners, our need for additional capital to fund our operations, our history of losses, and other risks inherent to the biopharmaceutical industry.
|SOURCE Polyphenon Pharma|
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