PHARMAGENESIS ESTABLISHES TEAMS TO DEVELOP TWO CANCER TREATMENT DRUG CANDIDATES
IN THE U.S.
Agent Induces Apoptosis; Adjunct Cancer Drug Restores Blood Cells During
ALTO, Calif. – April 2, 2001 – Pharmagenesis, Inc. has assembled teams to
develop two leading cancer therapy drug candidates – anti-cancer agent
PG490-88 and hematopoiesis enhancer PG2-2000 – for the U.S. market.
The two new development teams will work from Pharmagenesis’
headquarters in Palo Alto, Calif.
team is comprised of consultants with specialized experience in submitting drugs
for U.S. Food and Drug Administration (FDA) approval.
They will guide the preclinical studies and develop
procedures to manufacture the medicine, all to FDA standards.
At the completion of these studies, Pharmagenesis will submit
investigational new drug (IND) applications to the FDA for permission to start
phase one clinical trials.
laboratory research on PG490-88 indicates the new compound, alone
or in combination with conventional chemotherapy agents, induces apoptosis, or
programmed cell death and is an effective anticancer drug in
animal models of human cancers.
is similar to PG2, which successfully completed clinical trials in
China. In Chinese trials, regulated
by the Chinese State Drug Administration, PG2 showed efficacy in restoring blood
cells destroyed by chemotherapy. The Chinese SDA is the regulatory equivalent of the U.S. FDA
and employs stringent regulations similar to those used in U.S. drug trials.
will be developed for global marketing. “The upcoming IND of PG490-88 and
PG2-2000 brings us a step closer to our business objectives,” Nicolas Druz,
CEO, Pharmagenesis, said. “Pharmagenesis is fast becoming the ‘golden gate’ that
brings together China’s 4,000 years of drug knowledge and Western science.
It’s that combination that allows us to develop innovative and
efficient drugs for both the Western and Eastern markets.”
expects to file an IND application for PG490-88 by the end of this year. PG2-2000’s IND filing is planned for early 2002.
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.