Pharmion Corporation (Nasdaq:
PHRM) today released interim findings from its Phase II, multi-center
clinical study of Amrubicin, the company's third-generation synthetic
anthracycline currently in development for the treatment of small cell lung
cancer. These findings indicate favorable interim results in terms of
response rate and safety when comparing Amrubicin to the current treatment
standard, topotecan, in second-line treatment of platinum-sensitive
small-cell lung cancer patients with extensive disease (ED-SCLC). The early
results of this study were published online on the ASCO website during the
43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, Ill. (June 1- 5, 2007).
"Oncologists have very limited treatment options available for patients
with extensive-disease small cell lung cancer, and regrettably, patients
with this disease still have an exceptionally poor prognosis," said Andrew
R. Allen, chief medical officer of Pharmion. "We are encouraged by these
initial results which suggest Amrubicin's potential to improve the
treatment landscape for small cell lung cancer."
The trial compares Amrubicin and topotecan in patients with ED-SCLC
that initially responded to first-line platinum-based therapy but recurred
or progressed at least 90 days after completion of first-line treatment.
Study participants are randomized 2:1 to receive either Amrubicin (40 mg/m2
via 5- min.infusion daily x 3 days) or topotecan (1.5 mg/m2 via 30-min.
infusion daily x 5 days), both starting on Day 1 of a 21-day cycle.
Response data from 24 evaluable patients have been analyzed, 15 treated
with Amrubicin and nine with topotecan. Of the 15 Amrubicin patients, 40
percent showed an objective tumor response, including two complete
responses and four partial responses. All responses are confirmed. None of
the nine topotecan patients showed a response to the drug. The median
duration of progression free survival at the interim analysis was 4.1
months for Amrubicin patients compared to 2.0 months for topotecan
patients. Patients are being followed for overall survival.
Thirty patients in the trial were evaluable for toxicity and safety, 19
for Amrubicin and 11 for topotecan. The most common . grade 3 adverse
events were hematological and were generally equal between the two arms.
Cardiac adverse events were limited to tachycardia (< grade 3) for one
Amrubicin and two topotecan patients. No anthracycline-induced
cardiomyopathy has been observed to date.
"These results are extremely encouraging and entirely consistent with
the data reported from Japanese studies," said Mark A. Socinski, Associate
Professor of Medicine, Multidisciplinary Thoracic Oncology Program,
Lineberger Comprehensive Cancer Center, University of North Carolina, and a
principal investigator in the Phase 3 study which will begin shortly for
Amrubicin in second-line treatment of small cell lung cancer. "With no
apparent difference in activity between Japanese and non-Japanese patients,
Amrubicin may represent an important new treatment for this very difficult
to treat disease."
Pharmion has two additional ongoing Phase 2 studies of Amrubicin
therapy for small cell lung cancer patients; one as single-agent therapy in
patients refractory to first-line therapy; and one as single-agent or
combination therapy with cisplatin versus cisplatin plus etoposide in
previously untreated extensive stage patients.
Data Published on ASCO Website
A randomized phase 2 trial of Amrubicin vs. topotecan as second-line
treatment in extensive disease small-cell lung cancer (SCLC) sensitive to
platinum-based first line chemotherapy. R.M. Jotte; Abstract #18064.
About Amrubicin
Pharmion licensed the rights to Amrubicin in November 2006. In 2002,
Amrubicin was approved and launched for sale in Japan based on Phase 2
efficacy data in both SCLC and NSCLC. Since January 2005, Amrubicin has
been marketed by Nippon Kayaku, a Japanese pharmaceutical firm focused on
oncology, which licensed Japanese marketing rights from Dainippon Sumitomo,
the original developer of Amrubicin.
About Small Cell Lung Cancer
Small cell lung cancer is a disease in which malignant cells form in
the tissues of the lung, and which occurs almost exclusively in people who
smoke. While small cell lung cancer constitutes approximately 15 percent of
all lung cancers, SCLC tends to be more aggressive and fast growing than
the more common non-small cell lung cancer. Of the estimated 65,000
patients diagnosed with SCLC each year in the US and EU, approximately 60
percent of patients have extensive disease at diagnosis, and the remaining
40 percent present with localized, or limited stage, disease.
About Pharmion
Pharmion is a biopharmaceutical company focused on acquiring,
developing and commercializing innovative products for the treatment of
hematology and oncology patients in the U.S., Europe and additional
international markets. Pharmion has a number of products on the market
including the world's first approved epigenetic drug, Vidaza(R), a DNA
demethylating agent. For additional information about Pharmion, please
visit the company's website at pharmion.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995:
This release contains forward-looking statements, including summary
statements relating to the interim or preliminary results of clinical
trials involving Amrubicin. Such statements are based on current
expectations and involve a number of known and unknown risks and
uncertainties that could cause the final results to differ significantly
from the results summarized by such statements. Preliminary results may not
be confirmed upon final analysis of the detailed results of a trial and
additional information relating to the safety, efficacy or tolerability of
Amrubicin may be discovered upon further analysis of clinical trial data
and upon review and analysis of additional clinical trial data from this or
other clinical trials. Additional risks and uncertainties relating to
Pharmion and its business can be found in the "Risk Factors" section of
Pharmion's Quarterly Report on Form 10-Q for the quarterly period ended
March 31, 2007, its Annual Report on Form 10-K for the year ended December
31, 2006 and in Pharmion's other filings with the U.S. Securities and
Exchange Commission. Forward-looking statements speak only as of the date
on which they are made, and Pharmion undertakes no obligation to update
publicly or revise any forward-looking statement, whether as a result of
new information, future developments or otherwise. Pharmion also disclaims
any duty to comment upon or correct information that may be contained in
reports published by the investment community.
Pharmion Corporation
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