largely off-topic, emphasis is mine.......
OSI Pharmaceuticals, Inc. Announces Presentation of Early Phase II Data for OSI-774 at International Lung
Cancer Conference in Japan
UNIONDALE, N.Y., Sept. 13 /PRNewswire/ -- OSI Pharmaceuticals, Inc.
(Nasdaq: OSIP) announced today a summary of early data emerging from a Phase
II study of OSI-774 in non-small cell lung cancer patients. OSI-774 is a
potent, selective and orally active inhibitor of the Epidermal Growth Factor
Receptor (EFGR), an oncogene that is associated with the aberrant growth that
is characteristic of cancer cells. The data was communicated by investigators
at the 9th World Conference on Lung Cancer which is taking place this week in
Tokyo, Japan.
Philip Bonomi, M.D., a lead investigator, and Director of Medical Oncology
at the Rush Cancer Institute in Chicago reported that 4 of the first 12
evaluable patients in the study had objective partial responses, while another
4 patients showed evidence of a stabilization of their disease status.
"OSI-774 is a well tolerated, oral medication which is active in non-small
cell lung cancer," stated Dr. Bonomi. "We are particularly impressed because
we saw partial responses with OSI-774 in two patients who had been treated
previously with two and three different chemotherapy regimens."
The patients are involved in a 48 patient Phase II study in refractory
non-small cell lung cancer. Qualification criteria for the open label, single
agent study require the patients to have failed platinum-based chemotherapy
and to have tumors that are histopathologically confirmed to be EGFR positive.
The primary endpoint in the study is response rate with stable disease and
time-to-progression amongst the secondary end-points. In addition to Dr.
Bonomi, Dr. Roman Perez-Soler at New York University, Dr. Jim Rigas at
Dartmouth, New Hampshire, Dr. Lisa Hammond at CRTC in San Antonio and Dr. Dan
Karp of Beth Israel Deaconess Medical Center in Boston are investigators on
the study.
In a second presentation that will focus on an earlier Phase I study using
a weekly dosing regimen of OSI-774, Dr. Karp will also describe partial
responses in the ongoing Phase II study. In addition, Dr. Karp will update
earlier reports that the drug is well tolerated with a rash and diarrhea as
the principal side effects. Of the 28 patients in Dr. Karp's Phase I study, 8
patients remain alive over a year after inception of treatment and 12 patients
remained alive from 9-22 months.
Dr. Bonomi will present a more detailed summary of the trial's progress at
the European Organization for Research and Treatment of Cancer meeting on New
Drugs in Cancer Therapy in Amsterdam, The Netherlands on November 9, 2000. At
the same meeting, Dr. Lillian Siu from the Princess Margaret Hospital in
Toronto will summarize progress in a second ongoing 100 patient open label,
single agent study for head and neck cancer. OSI further announced today that
partial responses have also been observed in this study as well as in a 30
patient open label, single agent study in refractory ovarian cancer.
"We are delighted with the early progress in these trials," stated Colin
Goddard, Ph.D. Chairman, President and Chief Executive Officer, OSI
Pharmaceuticals, Inc. "While we would caution against an over-interpretation
of this data, based on the small patient numbers involved, we are
none-the-less confident that this data confirms OSI-774 to be an active and
well tolerated new anti-cancer agent and an important competitor in the new
class of EGFR inhibitors."
OSI-774 has now been tested in a total of 290 patients in the Phase I and
ongoing Phase II studies and demonstrates a well tolerated safety profile.
Data from the Phase I studies had previously revealed no adverse events that
were greater than moderate in severity at the Phase II treatment dose of 150
mg/day. In the daily dosing regimen study the dose limiting toxicity at
200mg/day was diarrhea. This observed side effect was effectively controlled
at the 150mg daily dose level using Loperamide (Imodium(R)). The second
adverse event observed in these studies was an acneiform rash analogous to
that reported for other EGFR agents. Taken in composite, the two Phase I
studies indicate an incidence of approximately 50% for these two side effects.
OSI Pharmaceuticals is a leading drug discovery company with a substantial
pipeline of product opportunities for commercialization with the
pharmaceutical industry. OSI's research programs are focused in the areas of
cancer therapeutics, cosmeceuticals, diabetes, and GPCR-directed drug
discovery. OSI utilizes a comprehensive drug discovery and development
capability to facilitate the rapid and cost-effective discovery and
development of novel, small molecule compounds in more than 40 research and
development programs. OSI is involved in long-term research alliances with
Pfizer, Tanabe, Novartis, Aventis, Sankyo, and Solvay.
This news release contains forward-looking statements. These statements
are subject to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the statements made.
Factors that might cause such a difference include, among others,
uncertainties related to the identification of lead compounds, the successful
pre-clinical development thereof, the completion of clinical trials, the FDA
review process and other governmental regulation, pharmaceutical
collaborators' competition from other pharmaceutical companies, product
pricing and third party reimbursement, and other factors described in OSI
Pharmaceuticals' filings with the Securities and Exchange Commission.
Additional information on OSI Pharmaceuticals is available on the World
Wide Web at: osip.com .
SOURCE OSI Pharmaceuticals, Inc.
Web Site: osip.com |
