Poniard Pharmaceuticals Announces Updated Positive Clinical Data from Phase 2 Trial of Picoplatin in Colorectal Cancer and New Phase 1 Cardiac Safety Trial Results
- Data Presented at AACR-NCI-EORTC's "Molecular Targets and Cancer Therapeutics" International Conference -
SOUTH SAN FRANCISCO, Calif., Nov. 17 /PRNewswire-FirstCall/ --
Poniard Pharmaceuticals, Inc. (NASDAQ:PARD) today announced updated clinical
data from its randomized, controlled Phase 2 trial of picoplatin in
patients with metastatic colorectal cancer (CRC). The updated
results indicated that picoplatin, given once every four weeks in
combination with 5-fluorouracil and leucovorin in the FOLPI
regimen, has comparable efficacy to oxaliplatin, given in
combination with 5-fluorouracil and leucovorin in the modified
FOLFOX-6 regimen, as a first-line therapy for CRC, as assessed by
one-year survival rate, progression-free survival (PFS) and disease
control. The Company also announced new results from its Phase 1
cardiac safety trial, which showed no clinical cardiac-related
events, as expected.
New data for both clinical trials were presented today in poster
sessions during the AACR-NCI-EORTC's "Molecular Targets and Cancer
Therapeutics" International Conference in Boston. Picoplatin is a
new generation platinum-based chemotherapy agent and the Company's
lead product candidate in development.
"Our updated proof-of-concept Phase 2 safety and efficacy
results continue to suggest that picoplatin could be superior to
oxaliplatin as a neuropathy-sparing alternative when used in
combination as a first-line treatment for metastatic colorectal
cancer. We are continuing follow-up on patients to obtain median
overall survival data to facilitate an end of Phase 2 meeting with
the U.S. Food and Drug Administration," said Jerry McMahon, Ph.D.,
chairman and CEO of Poniard. "Based on the current data in
colorectal cancer, as well as encouraging efficacy and safety data
from more than 1,100 cancer patients treated with picoplatin in
clinical trials, including the cardiac safety trial data presented
today, we are continuing discussions with potential
partners."
Phase 2 CRC Trial Design and Results
The randomized, controlled Phase 2 trial is evaluating
picoplatin as a neuropathy-sparing alternative to oxaliplatin for
the first-line treatment of metastatic CRC in 101 patients who have
not received prior chemotherapy. The trial is comparing the safety
and efficacy (assessed by objective tumor response, PFS and overall
survival) of intravenous picoplatin given once every four weeks in
combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI
regimen) with oxaliplatin given in combination with 5-fluorouracil
and leucovorin in the mFOLFOX-6 regimen.
The new data presented at the AACR-NCI-EORTC Conference
continued to demonstrate comparable efficacy between the two arms.
The median PFS was 6.8 months for FOLPI-treated patients and 7.0
months for mFOLFOX-6-treated patients. Disease control rates
(complete response plus partial response plus stable disease rates)
were also comparable between the two treatment groups with 75
percent of FOLPI-treated patients and 76 percent of
mFOLFOX-6-treated patients experiencing disease control. To date,
the one-year survival rate is 52 percent for patients treated with
FOLPI and 55 percent for patients treated with mFOLFOX-6.
With regard to safety, three separate assessments of neuropathy
showed that the use of FOLPI was associated with significantly less
neurotoxicity than mFOLFOX-6 (p<0.0019). Neuropathy occurred
later and was less frequent and less severe with FOLPI. Most
patients who decided to discontinue FOLFOX because of adverse
effects did so because of a Grade 1-3 neuropathy (7 patients on
FOLFOX verses no patients on FOLPI). Updated patient data
demonstrated that FOLPI was associated with more frequent and
severe, but manageable, neutropenia and thrombocytopenia that
resulted in a low frequency of clinical complications and growth
factor use for bone marrow suppression. Most other toxicities,
including gastrointestinal toxicity, were shown to be similar in
frequency between the two treatment groups.
Cardiac Safety Study Design and Results
Poniard worked collaboratively with the U.S. Food and Drug
Administration (FDA) to design the Phase 1 cardiac safety study,
which is required for new chemical entities. The study evaluated
the cardiac safety of picoplatin by determining its effect on the
cardiac QT/QTc interval by using time-matched pharmacokinetics and
electrocardiograms (ECGs). A total of 45 patients with advanced
solid malignancies received 150 mg/m2 picoplatin. The trial was
conducted at seven clinical sites in the United States.
Final results of the study presented at the AACR-NCI-EORTC
Conference showed that picoplatin had no effect on the QTcF
interval or any other ECG parameters evaluated. These findings
support the clinical data showing that picoplatin does not increase
the risk of serious ventricular arrhythmias. In addition, although
the study was not designed to evaluate efficacy, of the 45 cancer
patients evaluated, 11 had stable disease and two had a partial
response, including a patient who is still undergoing treatment
after more than seven months of picoplatin therapy.
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 is 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. More than 1,100 patients
have received picoplatin. 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. Picoplatin has demonstrated anti-tumor
activity in a variety of solid tumors. In addition to the Phase 2
CRC trial, Poniard is evaluating intravenous picoplatin in a Phase
2 trial in patients with castration-resistant prostate cancer.
Final results from the trial of an oral formulation of picoplatin
were presented earlier this year.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of innovative
oncology products to impact the lives of people with cancer. For
additional information please visit http://www.poniard.com/.
This release contains forward-looking statements, including
statements regarding the results of clinical trials, the potential
safety and efficacy of its product candidates, the Company's
business objectives and strategic goals, drug development plans,
and regulatory and partnering strategies. The Company's actual
results 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 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 results of the Company's discussions with the FDA and other
regulatory authorities; the potential safety and efficacy of the
Company's picoplatin product candidate; the receipt and timing of
any FDA and other required regulatory approvals, if any; if
regulatory approval of any product candidate is received, the
market's acceptance of that product or the occurrence post-approval
problems that may require the withdrawal of picoplatin from the
market; the Company's anticipated operating losses, need for future
capital and ability to obtain future funding; 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; the
Company's lack of sales and marketing experience; the Company's
ability to attract and retain key personnel and enter into
strategic partnerships; changes in technology, government
regulation and general market conditions; 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.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard
Pharmaceuticals, Inc.
Source: Poniard Pharmaceuticals, Inc.
CONTACT: Susan Neath (Investors), +1-212-301-7182, sneath@wcpglobal.com;
or Jani Bergan (Media), +1-415-946-1064, jbergan@wcpglobal.com, both
of
WeissComm Partners; or Rebecca Birbach (Investors), Burns
McClellan,
+1-212-213-0006, rbirbach@burnsmc.com
Web Site: http://www.poniard.com/
Posted: November 2009
