- Current report filing (8-K)
25 Setembro 2009 - 9:45AM
Edgar (US Regulatory)
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):
September 25, 2009 (September 24,
2009)
ALLOS
THERAPEUTICS, INC.
(Exact name of registrant
as specified in its charter)
Delaware
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000-29815
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54-1655029
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(State or other
jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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11080
CirclePoint Road, Suite 200
Westminster, Colorado
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80020
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(Address of principal
executive offices)
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(Zip Code)
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Registrants telephone
number, including area code:
(303) 426-6262
Not
applicable
(Former name or former
address, if changed since last report.)
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 (see General Instruction A.2.
below):
o
Written communications 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 5 Corporate Governance and Management
Item
5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers.
On September 24, 2009, Pablo J. Cagnoni, M.D. announced his
resignation as the Senior Vice President and Chief Medical Officer of Allos
Therapeutics, Inc. (the Company), effective as of September 30,
2009. The Company currently anticipates
undertaking a formal search to find a replacement for Dr. Cagnoni and
expects that existing members of management will assume Dr. Cagnonis
responsibilities until his replacement is appointed.
Section 8
Other Events
Item
8.01
Other Events.
On September 25, 2009,
the Company issued a press release announcing that the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN
TM
(pralatrexate injection) for use as a single
agent for the treatment of patients with
relapsed
or refractory peripheral T-cell lymphoma (PTCL)
. The
press release is attached hereto as Exhibit 99.1 and incorporated herein
by reference.
FOLOTYN was approved for
the treatment of patients with relapsed or refractory PTCL under the FDAs
accelerated approval program, which allows the FDA to approve products for
cancer or other life-threatening diseases based on initial positive clinical
data. Under these provisions, the
Company has agreed to the following post-marketing requirements (PMRs):
·
a Phase 3, multi-center, randomized
clinical study of sequential FOLOTYN versus observation in patients with newly
diagnosed aggressive PTCL who have responded following initial treatment with
chemotherapy based on CHOP (cyclophosphamide, doxorubicin, vincristine and
prednisone). The primary endpoint will
be progression-free survival (PFS).
Patients will be enrolled prior to initiation of the CHOP-based
regimen. Patients responding (either a
complete response or a partial response) after CHOP-based treatment will be
randomized 2:1 to FOLOTYN versus observation.
The Company has agreed to submit the results of this study by June 30,
2017.
·
a Phase 3, multi-center, randomized
clinical study comparing FOLOTYN in combination with systemic bexarotene versus
systemic bexarotene alone in patients with cutaneous T-cell lymphoma who are
refractory to at least one prior systemic therapy. The primary endpoint will be PFS. Response rate will be a secondary
endpoint. Prior to initiation of the
Phase 3 study, the Company will conduct a Phase 1 study to determine the
maximum tolerated dose of the combination.
The Company has agreed to complete the Phase 1 study by August 31,
2011 and submit the results of the Phase 3 study by September 30, 2015.
·
a Phase 1 clinical study to evaluate the
pharmacokinetics of FOLOTYN in relapsed or refractory lymphoma patients
(B-cell, T-cell and Hodgkins lymphoma) with mild to severe renal
impairment. The trial will have 3
cohorts of 6 patients for a total of 18 patients. Cohorts will be based on the severity of
renal impairment: severely impaired, moderately impaired and mildly
impaired. The FOLOTYN dose for the first
two cohorts will be determined based on the pharmacokinetics experience from
the PROPEL study and the third cohort will be dosed at the recommended dose (30
mg/m
2
).
The Company has agreed to submit the results of this study by January 31,
2013.
·
completion of an ongoing Phase 1 mass
balance clinical study to evaluate the excretion and metabolic profile of
FOLOTYN. The Company has agreed to
submit the results of this study by December 31, 2010.
Failure to complete the
studies or adhere to the timelines set by the FDA could result in penalties,
including fines or withdrawal of FOLOTYN from the market, unless the Company is
able to demonstrate good cause for not
2
completing the studies or adhering to the
timelines. The FDA may also initiate
proceedings to withdraw approval if our Phase 3 PMR studies fail to verify
clinical benefit of FOLOTYN.
Safe Harbor Statement
The information
contained in this report on Form 8-K and the press release incorporated
herein by reference should be considered in the context of the Companys
filings with the Securities and Exchange Commission and other public
announcements that the Company may make, by press release or otherwise, from
time to time. The information contained in this report on Form 8-K
and the press release incorporated herein by reference includes forward-looking
statements that are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements
include the Companys statements regarding the potential for FOLOTYN to offer
an important new treatment option or become a new standard for patients with
relapsed or refractory PTCL; the Companys anticipated timeline for making
FOLOTYN available to patients in the U.S.; the Companys intent to advance the
FOLOTYN clinical development program; and other statements that are other than
statements of historical facts. In some
cases, you can identify forward-looking statements by terminology such as may,
will, should, expects, intends, plans, anticipates, believes, estimates,
predicts, projects, potential, continue, and other similar terminology
or the negative of these terms, but their absence does not mean that a particular
statement is not forward-looking. Such forward-looking statements are not
guarantees of future performance and are subject to risks and uncertainties
that may cause actual results to differ materially from those anticipated by
the forward-looking statements. Important factors that may cause actual results
to differ materially include, but are not limited to, the risks and
uncertainties associated with developing adequate sales, marketing and
distribution capabilities; the acceptance of FOLOTYN in the marketplace; the
status of reimbursement from third party payors; the Companys dependence on
third party manufacturers; the Companys compliance with applicable regulatory
requirements, including the healthcare fraud and abuse laws and the Companys
post-marketing requirements, including additional clinical trials; and the
Companys access to capital to support its future operations, including product
development and commercialization plans for FOLOTYN. Additional information concerning these and
other factors that may cause actual results to differ materially from those
anticipated in the forward-looking statements is contained in the Risk Factors
section of the Companys Quarterly Report on Form 10-Q for the quarter
ended June 30, 2009, and in the Companys other periodic reports and
filings with the Securities and Exchange Commission. The Company cautions investors not to place
undue reliance on the forward-looking statements contained in this report on Form 8-K
and the press release incorporated herein by reference.
All information
contained in the press release and this report on Form 8-K is as of September 25,
2009. We undertake no duty or obligation to update any forward-looking
statements as a result of new information, future events or changes in our
expectations.
Section 9
Financial Statements and Exhibits
Item
9.01
Financial Statements and
Exhibits.
(d)
Exhibits
99.1
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Press Release, dated
September 25, 2009, entitled Allos
Therapeutics FOLOTYN First and Only FDA-Approved Therapy for Relapsed or
Refractory Peripheral T-cell Lymphoma.
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3
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.
Dated:
September 25,
2009
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ALLOS THERAPEUTICS, INC.
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By:
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/s/ Marc H. Graboyes
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Marc H. Graboyes
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Its:
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Senior Vice President,
General Counsel and Secretary
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4
EXHIBIT
INDEX
Exhibit No.
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Description
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99.1
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Press Release, dated September 25, 2009,
entitled Allos Therapeutics FOLOTYN
First and Only FDA-Approved Therapy for Relapsed or Refractory Peripheral
T-cell Lymphoma.
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5
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