BEGINS GOVERNMENT SUBSIDIZED CLINICAL TRIALS FOR PG2 IN TAIWAN
Restores Blood Cells During Chemotherapy
April 16, 2001 -
Pharmagenesis, Inc. has received approval from the Taiwan Department of Health
(DOH) to begin clinical trials in Taiwan for PG2, a drug that restores blood
cells after destruction of bone marrow cells induced by chemotherapy.
PG2 is the first traditional Chinese medicine-derived drug to be
authorized for clinical trials in Taiwan.
As part of a plan by the Ministry of Economics to support the
development of new and innovative drugs in Taiwan, the cost of the trials are
being partially subsidized by the Taiwan government.
a plant-derived hematopoiesis enhancer, can be used as an adjunct to cancer
therapy to improve patients’ quality of life.
In clinical trials carried out in major oncology and teaching hospitals
in China earlier, PG2 proved more efficient in stimulating growth of key blood
cell lines during chemotherapy than G-CSF, the positive control product used
in the trials.
Taiwan DOH has approved PG2 clinical trials through Pharmagenesis’ licensee
and subsidiary in Taiwan, Phytohealth Corporation, a joint venture between
Pharmagenesis and several Taiwanese biotech industry companies, including
Maywufa, the Koo’s group and Prohealthcare International.
DOH is subsidizing nearly half the trial costs.
“The approval and commencement of government-backed clinical trials of PG2 in Taiwan is an official acknowledgement that extracts from plants used in traditional Chinese medicine potentially are a reliable and cost-efficient source for the development of new ethical drugs,” Nicolas Druz, CEO, Pharmagenesis, said.
trials in Taiwan are regulated by the DOH and are modeled after U.S. FDA
guidelines. The PG2 clinical trials
will be performed at various approved medical institutions in Taiwan, including
the Veteran’s General Hospital and the National Taiwan Hospital.
About Pharmagenesis, Inc.
develops anticancer therapies and treatments for cancer therapy-related
bone-marrow suppression and for the management of transplant rejection.
The privately held company focuses on developing ethical pharmaceuticals
from purified extracts of plants that have been employed in traditional Chinese
medicine for more than 4,000 years. Efficacy
is validated by clinical trials conforming to standards of appropriate
government regulatory agencies. Pharmaceuticals
developed and/or licensed by the company are being commercialized initially in
the high-growth markets of China and Taiwan.
corporate headquarters and R & D facility, employing cutting-edge Western
medical research techniques, are located in Palo Alto, Calif.
Pharmagenesis also has operations in Beijing and Taipei.