Poniard Pharmaceuticals Presents Positive Survival Data from a Phase 2 Clinical Study of Picoplatin in Metastatic Prostate Cancer at the 2010 American Society of Clinical Oncology Genitourinary Cancers Symposium
SOUTH SAN FRANCISCO, Calif., March 5 /PRNewswire-FirstCall/ --
Poniard Pharmaceuticals, Inc. (NASDAQ:PARD) , a biopharmaceutical company
focused on innovative oncology therapies, today announced the
presentation of positive final data, including survival data, from
the Company's Phase 2 clinical trial of picoplatin as a first-line
therapy in men with metastatic castration-resistant
(hormone-refractory) prostate cancer (CRPC). The results were
presented in a General Poster Session today at the 2010 American
Society of Clinical Oncology's Genitourinary Cancers Symposium in
San Francisco, CA.
The final data showed that picoplatin, in combination with
docetaxel and prednisone, the current standard of care for CRPC,
produced a clinically meaningful benefit in patients as measured by
overall survival, progression-free survival (PFS) and prostate
specific antigen (PSA) response rate. These results also
demonstrated that picoplatin can be safely administered with full
doses of docetaxel and prednisone. In addition, no neurotoxicity
was observed in these patients. Neutropenia was the most common
hematologic adverse event, and was managed with supportive
care.
"Safety and efficacy results from this study, particularly the
overall survival data, are encouraging and suggest that picoplatin
in this combination regimen has the potential to play a meaningful
role in the treatment of metastatic prostate cancer," said William
K. Oh, M.D., professor of medicine and urology and chief, Division
of Hematology and Medical Oncology, Tisch Cancer Institute at Mount
Sinai School of Medicine. "The results also support the study of
picoplatin as a first-line treatment for advanced prostate cancer,
a disease for which too few treatment options currently
exist."
"We believe these results reflect the promise of picoplatin as a
safe and effective platinum chemotherapeutic agent in prostate
cancer, and suggest picoplatin could play a significant role in the
treatment of other tumor types where platinum and taxane
chemotherapies are currently used, further supporting picoplatin's
value proposition to potential partners," said Ronald Martell,
chief executive officer of Poniard. "We intend to consult with our
clinical advisory board and the U.S. Food and Drug Administration
to finalize registration strategies in prostate cancer while
simultaneously exploring potential partnership opportunities to
support the continued development of picoplatin in multiple solid
tumor indications."
Phase 2 Trial Design and Results
The Phase 2 trial enrolled 32 men. The trial was designed to
evaluate the efficacy and safety of intravenous picoplatin (120
mg/meter squared) administered every three weeks in combination
with full doses of docetaxel (75 mg/meter squared) with twice daily
prednisone (5 mg) as a first-line treatment in chemotherapy-naive
patients with metastatic CRPC. Treatment continued for up to 10
cycles of therapy, as specified in the protocol. PSA response was
the primary endpoint. Secondary endpoints include duration of PSA
response, radiologic response, PFS, overall survival and safety.
Results from the study included:
-- Median overall survival was 21.4 months in 29 patients who received
picoplatin in combination with docetaxel and prednisone. Data from
published literature report a median overall survival of 18.9 months
for patients who received docetaxel 75 mg/meter squared and prednisone
5 mg alone.(1)
-- Progression free survival was 7.4 months.
-- PSA response was achieved in 78 percent of evaluable patients. Data
from published literature report a PSA response of 45 percent in
patients who received docetaxel 75 mg/meter squared and prednisone 5
mg alone.(1) In addition, 30 percent of these patients experienced
PSA level normalization following treatment with the picoplatin,
docetaxel and prednisone combination.
-- Picoplatin was safely administered with full-dose docetaxel and
prednisone for up to 10 cycles of therapy. Neuropathy was not
observed in this study. Data from published literature report
evidence of neuropathy in 30 percent of patients, including severe
neuropathy (Grade 3/4) in 1.8 percent of patients receiving 75
mg/meter squared docetaxel and prednisone alone every three weeks.(1)
-- Neutropenia was the most common hematologic adverse event, and was
managed with supportive care. In contrast to data from picoplatin
monotherapy studies, thrombocytopenia was less severe and less
frequent when picoplatin was administered in combination with
docetaxel.
About Prostate Cancer
More than two million American men are currently living with
prostate cancer, and it is the most common cancer, other than skin
cancers, among men in the U.S. In 2009, an estimated 192,280 new
cases of prostate cancer were expected to be diagnosed. Prostate
cancer is the second leading cause of death in American men, behind
only lung cancer, with an estimated 27,360 deaths in 2009.(2) All
patients with metastatic prostate cancer eventually become
refractory to hormone treatment. Docetaxel in combination with
prednisone is the current standard of care in the United States.
According to IntrinsiQ, 88.5 percent of U.S. patients received a
docetaxel-containing regimen for first-line treatment of CRPC in
2008. To date, a docetaxel-containing regimen is the only FDA
approved treatment regimen proven to prolong the lives of patients
with CRPC.
About Picoplatin
Picoplatin is a new and differentiated platinum-based
chemotherapeutic agent that is in clinical development for multiple
cancer indications, treatment combinations and by two routes of
administration. It was designed to overcome platinum resistance
associated with chemotherapy in solid tumors. Study data to date
suggest that picoplatin has an improved safety profile relative to
existing platinum-based cancer therapies and can be easily combined
and safely administered with other currently marketed oncology
products. Approximately 1,100 patients have received picoplatin in
clinical trials. Results obtained to date suggest that hematologic
events are common, but manageable. Kidney toxicity (nephrotoxicity)
and nerve toxicity (neurotoxicity) are less frequent and less
severe than is commonly observed with other platinum chemotherapy
drugs.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of innovative
oncology products. For additional information please visit
http://www.poniard.com/.
Forward-Looking Statement
This release contains forward-looking statements interpreting
the results of the Company's Phase 2 clinical trial of picoplatin
in castration-resistant prostate cancer and describing the
Company's regulatory and partnering strategies with respect to
picoplatin in that and other cancer indications. Actual results and
events may differ materially from those indicated in these
forward-looking statements based on a number of factors, including
risks and uncertainties inherent in the Company's business,
including, but not limited to, the results and timing of the
Company's discussions with the FDA; the potential safety, efficacy
and commercial viability of picoplatin; the risk that the Company's
additional analyses of data from clinical trials of picoplatin may
produce negative or inconclusive results, or may be inconsistent
with previously announced results or previously conducted trials;
the Company's anticipated future operating losses, need for future
capital and ability to obtain future funding; the Company's ability
to retain key personnel and enter into strategic partnerships or
other relationships to support the continued development of
picoplatin on favorable terms, or at all; competition from third
parties; the Company's ability to preserve and protect its
intellectual property rights; the Company's dependence on
third-party manufacturers, suppliers and other contractors; changes
in technology, government regulation and general market conditions;
the receipt and timing of any FDA and other required regulatory
approvals, if any; and the risks and uncertainties described in the
Company's current and periodic reports filed with the Securities
and Exchange Commission (SEC), including the Company's Annual
Report on Form 10-K for the year ended December 31, 2008, and its
Quarterly Report on Form 10-Q for the period ended September 30,
2009. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. The Company undertakes no obligation to update any
forward-looking statement to reflect new information, events or
circumstances after the date of this release or to reflect the
occurrence of unanticipated events.
(1) Tannock et al, NEJM 2004;351:1502-12.
(2) American Cancer Society, Cancer Facts and Figures
2009.
Source: Poniard Pharmaceuticals, Inc.
CONTACT: Investors & Media, Susan Neath of WCG,
+1-212-301-7182,
sneath@wcgglobal.com
Web Site: http://www.poniard.com/
Posted: March 2010
