Polyphenon Pharma, an emerging
research-based pharmaceutical company, 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.
About CLL
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
polyphenon-pharma
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.
Polyphenon Pharma
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