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0001104659-10-012611.txt : 20100308
0001104659-10-012611.hdr.sgml : 20100308
20100308081542
ACCESSION NUMBER: 0001104659-10-012611
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 5
CONFORMED PERIOD OF REPORT: 20100305
ITEM INFORMATION: Results of Operations and Financial Condition
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20100308
DATE AS OF CHANGE: 20100308
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: PONIARD PHARMACEUTICALS, INC.
CENTRAL INDEX KEY: 0000755806
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 911261311
STATE OF INCORPORATION: WA
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-16614
FILM NUMBER: 10662388
BUSINESS ADDRESS:
STREET 1: 7000 SHORELINE COURT
STREET 2: SUITE 270
CITY: SO. SAN FRANCISCO
STATE: CA
ZIP: 94080
BUSINESS PHONE: 2062862501
MAIL ADDRESS:
STREET 1: 300 ELLIOTT AVENUE WEST
STREET 2: SUITE 500
CITY: SEATTLE
STATE: WA
ZIP: 98119-4114
FORMER COMPANY:
FORMER CONFORMED NAME: NEORX CORP
DATE OF NAME CHANGE: 19920703
8-K
1
a10-5295_18k.htm
8-K
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported) March 5, 2010
Poniard Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in
Charter)
Washington
|
|
0-16614
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91-1261311
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(State
or Other Jurisdiction
|
|
(Commission File No.)
|
|
(IRS Employer
|
of Incorporation)
|
|
|
|
Identification
No.)
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7000
Shoreline Court, Suite 270, South San Francisco, California
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|
94080
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(Address of principal
executive offices)
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|
(Zip Code)
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(650)
583-3774
(Registrants telephone number, including
area code)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
o Written communication
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Section 2
Financial Information
Item 2.02. Results
of Operations and Financial Condition.
The Company issued a press release dated March 8,
2010, announcing its financial results for the fourth quarter and year ended December 31,
2009. The full text of the press release is set forth in Exhibit 99.1
attached hereto. The press release should be read in conjunction with the
note regarding forward-looking statements, which is included in the text of the
press release.
The information in this Item 2.02 and attached as Exhibit 99.1
to this Report will not be treated as filed for the purposes of Section 18
of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise
subject to the liabilities of that section. This information will not be
incorporated by reference into any filing under the Securities Act of 1933, or
into another filing under the Exchange Act, unless that filing expressly
incorporates this information by reference.
Section 8
Other Events
Item 8.01. Other
Events.
On March 5, 2010, the Company announced
positive final data, including survival data, from its Phase 2 clinical trial
of picoplatin as a first-line therapy in men with metastatic
castration-resistant (hormone-refractory) prostate cancer. The data were presented in the General Poster
Session at the 2010 American Society of Clinical Oncologys Genitourinary
Cancers Symposium in San Francisco, CA.
See press release dated March 5, 2010, attached
hereto as Exhibit 99.2 and incorporated herein by reference. The press release should be read in
conjunction with the note regarding forward-looking statements, which is
included in the text of the press release.
Section 9
Financial Statements and Exhibits
Item 9.01. Financial
Statements and Exhibits.
(d) Exhibits.
99.1 Press release dated March 8,
2010
99.2 Press release dated March 5,
2010
2
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
|
Poniard Pharmaceuticals, Inc.
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|
|
|
Dated: March 8, 2010
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By:
|
/s/Gregory L. Weaver
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Name: Gregory L. Weaver
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Title: Chief Financial Officer
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3
EXHIBIT
INDEX
Exhibit No.
|
|
Description
|
99.1
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|
Press Release dated
March 8, 2010
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|
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|
99.2
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Press
Release dated March 5, 2010
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4
EX-99.1
2
a10-5295_1ex99d1.htm
EX-99.1
EXHIBIT 99.1
Poniard Pharmaceuticals Reports
Fourth Quarter and Year End 2009 Financial Results
- Conference Call Today at 8:30 a.m.
Eastern Time -
South
San Francisco, Calif. (March 8, 2010) Poniard Pharmaceuticals, Inc.
(Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology
therapies, today reported financial results for the fourth quarter and year
ended December 31, 2009.
Picoplatins value
proposition rests on establishing it as the preferred platinum, said Ronald A.
Martell, chief executive officer of Poniard.
With nearly 1,100 patients treated in clinical trials to date,
picoplatin has already demonstrated clinically meaningful safety and efficacy
in a variety of solid tumor indications as a single agent or in combination. We look forward to finalizing registration
strategies in a number of these settings with our clinical advisors and the
Food and Drug Administration, while simultaneously evaluating strategic
opportunities, including potential partnerships, which we believe will enable
us to unlock the full value of picoplatin.
Recent Clinical and Corporate
Developments
Picoplatin Clinical
Update
· Prostate Cancer: On Friday, March 5, 2010, Poniard
presented final data from the Companys Phase 2 clinical trial of picoplatin in
32 men with metastatic castration-resistant (hormone-refractory) prostate
cancer (CRPC) during the American Society of Clinical Oncology (ASCO) 2010
Genitourinary Cancers Symposium. These
data indicated that picoplatin, when added to the recommended first-line
therapy of docetaxel and prednisone for CRPC, is active, as demonstrated by
overall survival (21.4 months) in 29 evaluable patients, progression-free
survival (PFS) (7.4 months), and prostate specific antigen (PSA) response rate
(78 percent). In contrast, data from
published literature demonstrate an overall survival benefit of 18.9 months and
a PSA response of 45 percent for patients who received recommended doses of
docetaxel and prednisone alone.(1) The Phase 2 trial evaluated 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 daily prednisone (5 mg) as a first-line treatment in chemotherapy näive
patients with metastatic CRPC. These
results also showed that picoplatin can be safely administered with full doses
of docetaxel and prednisone, without neurotoxicity being observed in these
patients.
· Colorectal Cancer (CRC): During the
ASCO 2010 Gastrointestinal Cancers Symposium in January, Poniard presented
final results from a randomized, controlled Phase 2 trial evaluating picoplatin
as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment
of metastatic CRC. The 101 patient study
met its primary objective, as picoplatin in combination with 5-fluorouracil and
leucovorin in the FOLPI regimen produced a statistically significant reduction
in neurotoxicity, p <0.004, compared to oxaliplatin given in combination
with 5-fluorouracil and leucovorin in the FOLFOX regimen. Neuropathy was 2.5 times more frequent for
FOLFOX- treated patients compared to FOLPI-treated patients, and no Grade 3/4
neuropathy occurred in the FOLPI treated patients. Results suggest that FOLPI had anti-tumor
activity comparable to FOLFOX, as measured by disease control, PFS and overall
survival. Hematologic toxicity was the
most frequent adverse event in the FOLPI regimen, but was manageable.
· Small Cell Lung Cancer
(SCLC): In November 2009, the Company reported results from the Phase 3
SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which enrolled 401
patients and evaluated intravenous picoplatin in patients who were refractory
to or who progressed within six months following initial treatment with a
platinum-based therapy. While the data
analysis showed that the study did not meet its primary endpoint of overall
survival the data suggest a potential trend toward a survival advantage in SCLC
patients treated with picoplatin and best supportive care compared to best
supportive care alone. An imbalance in
the use of post-study chemotherapy was observed in favor of patients who
received best supportive care alone compared to patients who received
picoplatin plus best supportive care, and we believe that this may have been a
significant factor contributing to the trial outcome. The intent-to-treat
analysis was based on 321 patient deaths and showed a hazard ratio of 0.82 and
a p value of 0.089.
Corporate Update
· In February 2010, the Company
secured a committed equity financing facility with Commerce Court Small Cap
Value Fund Ltd, pursuant to which it may, subject to certain limitations, sell
up to $20 million of its registered common stock to Commerce Court over an
approximately 18-month period. The
Company believes that this facility offers a competitive cost of capital and a
flexible structure to help finance its regulatory and partnering strategies to
support the continued development of picoplatin.
· In February 2010, Poniard announced
management changes and a realignment of the Companys workforce. Ronald A. Martell was appointed chief
executive officer, succeeding Jerry McMahon, Ph.D., who remains as
non-executive chairman of the Board of Directors. In addition, Michael S. Perry, DVM, Ph.D.,
has been named president and chief medical officer. The Company also reduced its workforce by
approximately 57 percent in order to focus its resources on the ongoing
development of picoplatin in solid tumors.
· In the fourth quarter of 2009, Poniard
raised net proceeds of $13.8 million from the sale of common stock under the
Companys committed equity financing facility with Azimuth Opportunity
Ltd. That facility terminated by its
terms on December 22, 2009.
2010 Goals and Objectives
The Company will focus on
the following goals and objectives in 2010:
· Pursue strategic opportunities, including
a partnership to help advance the clinical development of picoplatin in
multiple indications and two formulations;
· Pursue a process with the Food and Drug
Administration to identify a regulatory path forward for picoplatin in small
cell lung cancer, and
· Leverage insights gained from Phase 2
colorectal, prostate and ovarian cancer trials to develop registration strategies
for these indications in collaboration with key opinion leaders and the FDA
Fourth Quarter 2009 Financial
Results
The
Company reported a net loss of $13.2 million ($0.36 diluted loss per share on a
loss applicable to common shares of $13.3 million) for the quarter ended December 31,
2009, compared with a net loss of $13.9 million ($0.41 diluted loss per share
on a loss applicable to common shares of $14.1 million) for the quarter ended December 31,
2008. The Company reported a net loss of
$45.7 million ($1.31 diluted loss per share on a loss applicable to common
shares of $46.2 million) for the year ended December 31, 2009, compared
with a net loss of $48.6 million ($1.41 diluted loss per share on a loss
applicable to common shares of $49.1 million) for the same period in 2008.
Total
operating expenses for the quarter ended December 31, 2009, were $12.4
million compared with $13.4 million for the quarter ended December 31,
2008, and were $43.0 million for the year ended December 31, 2009,
compared with $49.2 million for the same period in 2008. Total operating
expenses for the quarter and year ended December 31, 2009 include charges
of $1.5 million and $2.5 million, respectively, for the $1.5 million
asset
impairment loss on dedicated manufacturing equipment effective December 31,
2009, and for the $1.0 million restructuring and related asset impairment
resulting from the Companys implementation of a strategic restructuring plan
to discontinue its in-house preclinical research operations and reduce its
workforce by approximately 12 percent effective March 31, 2009.
Research
and development expenses were $7.2 million for the quarter ended December 31,
2009, compared with $10.0 million for the quarter ended December 31,
2008. Research and development expenses
were $25.7 million for the year ended December 31, 2009, compared with
$33.7 million for the same period in 2008.
General
and administrative expenses were $3.8 million for the quarter ended December 31,
2009, compared with $3.3 million for the quarter ended December 31,
2008. General and administrative
expenses were $14.7 million for the year ended December 31, 2009, compared
with $15.4 million for the same period in 2008.
Cash and investment securities as of December 31, 2009, were
$43.4 million, compared with $72.8 million at December 31, 2008. The Company believes that its existing cash and
investment securities, together with its projected operating and financing
results, will provide adequate resources to fund the Companys operations at
least through the end of 2010.
Conference Call Details
Poniards management team
will host a conference call and Webcast today at 8:30 a.m. Eastern
Time/5:30 a.m. Pacific Time. To participate in the call by telephone,
please dial 866-543-6403 (United States) or 617-213-8896 (International). The
passcode for the conference call is 50673823. In addition, the call is being
Webcast and can be accessed on the Events page of the News &
Events section of the Companys Web site at http://www.poniard.com. A replay
of the Webcast will be available on the Companys Web site for 10 days.
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 Statements
This
release contains forward-looking statements describing the Companys results of
operations and financial condition, the Companys 2010 goals and objectives, including
its regulatory and partnering strategies focused on optimizing the potential
value of picoplatin, and the adequacy of the Companys resources to
successfully implement and pursue these strategies. 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
Companys business, including, but not limited to, the results and timing of
the Companys discussions with the FDA; the potential safety, efficacy and
commercial viability of picoplatin; the risk that the Companys 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 Companys anticipated future operating
losses, need for future capital and ability to obtain future funding; the
Companys 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 Companys
ability to preserve and protect its intellectual property rights; the Companys
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 Companys current and periodic
reports filed with the Securities and Exchange Commission (SEC), including the
Companys 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.
For
Further Information:
Susan
Neath (Investors & Media)
WCG
212-301-7182
sneath@wcgworld.com
(1)Tannock
et al, NEJM 2004;351:1502-12.
# # #
Poniard Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In
thousands, except per share data)
(Unaudited)
|
|
Three Months Ended December 31,
|
|
Twelve Months Ended December 31,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
(Note 1)
|
|
7,194
|
|
10,011
|
|
25,739
|
|
33,732
|
|
General and administrative
(Note 1)
|
|
3,769
|
|
3,346
|
|
14,698
|
|
15,425
|
|
Restructuring &
asset impairment
|
|
1,485
|
|
|
|
2,541
|
|
|
|
Total operating expenses
|
|
12,448
|
|
13,357
|
|
42,978
|
|
49,157
|
|
Loss from operations
|
|
(12,448
|
)
|
(13,357
|
)
|
(42,978
|
)
|
(49,157
|
)
|
Other income (expense),
net
|
|
(720
|
)
|
(585
|
)
|
(2,737
|
)
|
592
|
|
Net loss
|
|
(13,168
|
)
|
(13,942
|
)
|
(45,715
|
)
|
(48,565
|
)
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends
|
|
(125
|
)
|
(125
|
)
|
(500
|
)
|
(500
|
)
|
Loss applicable to common
shares
|
|
$
|
(13,293
|
)
|
$
|
(14,067
|
)
|
$
|
(46,215
|
)
|
$
|
(49,065
|
)
|
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.36
|
)
|
$
|
(0.41
|
)
|
$
|
(1.31
|
)
|
$
|
(1.41
|
)
|
Shares used in calculation
of loss per share:
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
36,899
|
|
34,688
|
|
35,272
|
|
34,686
|
|
Condensed
Consolidated Balance Sheets
(In
thousands)
|
|
December 31, 2009
|
|
December 31, 2008
|
|
|
|
|
|
|
|
(Unaudited)
|
|
(Note 2)
|
|
|
|
|
|
ASSETS:
|
|
|
|
|
|
|
|
|
|
Cash and investment securities
|
|
$
|
43,389
|
|
$
|
72,755
|
|
|
|
|
|
Cash - restricted
|
|
281
|
|
281
|
|
|
|
|
|
Facilities and equipment, net
|
|
219
|
|
1,123
|
|
|
|
|
|
Licensed products, net
|
|
7,592
|
|
8,807
|
|
|
|
|
|
Other assets
|
|
961
|
|
1,266
|
|
|
|
|
|
Total assets
|
|
$
|
52,442
|
|
$
|
84,232
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY:
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
17,127
|
|
$
|
19,140
|
|
|
|
|
|
Long term liabilities
|
|
11,671
|
|
17,445
|
|
|
|
|
|
Shareholders equity
|
|
23,644
|
|
47,647
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$
|
52,442
|
|
$
|
84,232
|
|
|
|
|
|
Note 1: Patent related legal expenses are included in
G&A expenses beginning in 2009.
These expenses, which have been reclassifed for 2008 to conform to the
2009 presentation, are $1.0 million for each of 2009 and 2008.
Note 2: Derived from audited financial statements
included in the Companys Annual Report on Form 10-K for the year ended December 31,
2008.
EX-99.2
3
a10-5295_1ex99d2.htm
EX-99.2
EXHIBIT 99.2
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,
2010 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 Companys
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 Oncologys
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 picoplatins 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-näive patients with metastatic CRPC. Treatment continued for up to 10 cycles of
therapy, as specified in the protocol.
PSA response, defined as a reduction from baseline of at least 50
percent, 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
Companys Phase 2 clinical trial of picoplatin in castration-resistant prostate
cancer and describing the Companys 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 Companys business, including, but not limited to, the results
and timing of the Companys discussions with the FDA; the potential safety,
efficacy and commercial viability of picoplatin; the risk that the Companys
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 Companys anticipated
future operating losses, need for future capital and ability to obtain future
funding; the Companys 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
Companys ability to preserve and protect its intellectual property rights; the
Companys 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 Companys current and periodic reports filed
with the Securities and Exchange Commission (SEC), including the Companys
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.
For
Further Information:
Susan
Neath (Investors & Media)
WCG
212-301-7182
sneath@wcgglobal.com
(1)Tannock et al, NEJM 2004;351:1502-12.
(2)American
Cancer Society, Cancer Facts and Figures 2009.
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