- Current report filing (8-K)
December 08 2008 - 1:15PM
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):
December 8,
2008 (December 6, 2008)
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 7 Regulation FD
Item 7.01
Regulation FD Disclosure.
On December 6, 2008, Allos Therapeutics, Inc.,
a Delaware corporation (the Company), issued a press release announcing that
results from two pralatrexate (PDX) studies were presented as posters during
the 50th Annual Meeting of the American Society of Hematology, on December 6,
2008, in San Francisco, California. The
press release is attached hereto as Exhibit 99.1 and incorporated herein
by reference.
On December 7,
2008, the Company issued a press release reporting the presentation of top line
results from PROPEL, the Companys pivotal Phase 2 trial of pralatrexate in
patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), at
the 50th Annual Meeting of the American Society of Hematology. The press release is attached hereto as
Exhibit 99.2 and incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K,
the information presented under this Item 7.01 and attached as
Exhibits 99.1 and 99.2, except insofar as such information is also set
forth under Item 8.01 below, shall not be deemed filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended, except as expressly set forth by specific reference in such a filing.
Section 8 Other Events
Item 8.01
Other Events.
Pralatrexate in CTCL
(Phase 1)
On December 6, 2008, a
poster (abstract 1569) entitled Pralatrexate (PDX) is Active in Cutaneous
T-Cell Lymphoma: Preliminary Results of a Multi-center Dose-finding Trial was
presented at the 50th Annual Meeting of the American Society of
Hematology. The poster reported interim
data from the Companys ongoing Phase 1 trial of pralatrexate in patients with
relapsed or refractory cutaneous T-cell lymphoma (CTCL). Data were presented
on 24 patients, including 22 evaluable patients who completed at least one
cycle of treatment at doses ranging from 10-30 mg/m2 as part of a weekly
schedule for two or three weeks followed by one week of rest. Responses were
observed in 12 of 22 evaluable patients (55%), including one complete response
and 11 partial responses. Patients received a median of four prior systemic
therapies. The most common adverse event was mucosal inflammation, with Grade
1/2 mucosal inflammation observed in 11 of 24 patients and Grade 3 mucosal
inflammation observed in 4 of 24 patients. There was no Grade 4 mucosal
inflammation and no thrombocytopenia above Grade 1. Up to 56 evaluable patients
will be enrolled in the study with the objective of determining the optimal
dose and schedule for pralatrexate in this patient population. Steven Horwitz,
M.D., Assistant Attending Physician, Lymphoma Service, Memorial Sloan-Kettering
Cancer Center, is the Principal Investigator of the study.
Pralatrexate and
Gemcitabine in Lymphoproliferative Malignancies (Phase 1/2a)
On December 6, 2008, a
poster (abstract 1570) entitled A Phase 1/2a Open-label Study of Pralatrexate
and Gemcitabine in Patients with Relapsed or Refractory Lymphoproliferative
Malignancies was presented at the 50th Annual Meeting of the American Society
of Hematology. The poster reported interim data from the Companys ongoing
Phase 1/2a open-label, multi-center study of pralatrexate in combination with
gemcitabine in patients with relapsed or refractory non-Hodgkins lymphoma
(NHL) or Hodgkins lymphoma. Data were
presented on 27 patients, 22 of whom were evaluable for response. Patients have been enrolled in eight cohorts
with different doses and schedules.
Partial responses were observed in 6 of 22 evaluable patients, including
five patients on a sequential dosing schedule and one patient on a same-day
dosing schedule. Patients received a
median of three prior systemic regimens.
The most common adverse event was thrombocytopenia, with Grade 3
observed in four patients and Grade 4 observed in seven patients. The maximum tolerated dose for the sequential
dosing schedule was established as 10 mg/m2 of pralatrexate followed by 300
mg/m2 of gemcitabine, once every two weeks.
Enrollment in the trial
2
is ongoing to determine the
maximum tolerated dose for the same same-day dosing schedule. Dr. Horwitz is the Principal
Investigator of the study.
Pralatrexate
in Peripheral T-cell Lymphoma (Pivotal Phase 2 PROPEL)
On
December 7, 2008,
the
Company announced the presentation of preliminary top line results from PROPEL, the Companys pivotal Phase 2 trial
of pralatrexate in patients with relapsed or refractory PTCL, at the 50
th
Annual Meeting of the American
Society of Hematology.
The results according to
central independent oncology review at the time of the analysis were as
follows:
·
29 of 109 evaluable patients (27%) achieved
either a complete or partial response;
·
11 evaluable patients had a complete response
or complete response unconfirmed;
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18 evaluable patients had a partial response;
·
23 evaluable patients had stable disease as
best response; and
·
3 patients had insufficient data to assess
response and 14 patients could not be assessed for response because they
discontinued treatment prior to completion of cycle one. These patients are
included in the evaluable patient population for all efficacy analyses.
The results according to the
PROPEL investigators at the time of the analysis were as follows:
·
42 of 109 evaluable patients (39%) achieved
either a complete or partial response;
·
18 evaluable patients had a complete response
or complete response unconfirmed;
·
24 evaluable patients had a partial response;
and
·
21 evaluable patients had stable disease as
best response.
PROPEL patients received a
median of three prior systemic treatment regimens (range of 1-12), including 18
patients (16%) who had previously undergone an autologous stem cell
transplant. Patient response evaluations
will continue and all patients will be followed for long-term survival.
In the trial, 69% of the
patients who responded did so after cycle one of therapy. The median duration
of treatment in responding patients was 179 days at the time of this analysis.
The duration of response exceeded three months in 17 of 29 responders (59%),
including 6 of the 17 patients who continued on treatment. An accurate estimate
of the median duration of response cannot be reported at this time due to the
current length of follow up. Patients will continue to be followed until the
median duration of response can be accurately estimated. Following review of the final results of the
trial, the Company intends to submit a New Drug Application to the U.S. Food
and Drug Administration in the first half of 2009 to seek marketing approval
for pralatrexate for the treatment of patients with relapsed or refractory
PTCL.
The most common grade 3/4
adverse events were thrombocytopenia, which was observed in 32% of patients;
mucosal inflammation in 21% of patients; neutropenia in 20% of patients; and
anemia in 18% of patients.
* * *
Safe
Harbor Statement
The
information contained in this report on Form 8-K and the press releases
incorporated herein by reference should be considered in the context of the
Companys filings with the Securities and Exchange
3
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 releases 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 statements concerning the potential activity of pralatrexate when
administered as a single agent in patients with CTCL and in combination with
gemcitabine in patients with lymphoma; the potential for pralatrexate to offer
a new treatment option for patients with relapsed or refractory PTCL; the Companys
intent and projected timeline to submit a New Drug Application for pralatrexate
as a treatment for patients with relapsed or refractory PTCL; 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. These
risks and uncertainties include, among others: that the PROPEL trial may not
demonstrate that pralatrexate is both safe and effective for the treatment of
patients with relapsed or refractory PTCL; that the results of the PROPEL trial
may not support an application for marketing approval in the United States or
any other country; that an application for marketing approval may not be
accepted for priority review or at all by the U.S. Food and Drug Administration
or any other regulatory authority; and that the Company may lack the financial
resources and access to capital to fund future clinical trials for pralatrexate
or any of its other product candidates. 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 Annual Report on Form 10-K for the year ended December 31,
2007 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 releases
incorporated herein by reference.
Results
from clinical studies, including the Companys studies described in this report
on Form 8-K and the press releases incorporated herein, are not
necessarily predictive of future clinical results. Interim results may not be confirmed upon
full analysis of the detailed final results of a trial and additional
information relating to the safety, efficacy or tolerability of the Companys
product candidates, including pralatrexate, may be discovered upon further
analysis of trial data. If the Companys
product candidates do not meet safety or efficacy endpoints in clinical
evaluations, they will not receive regulatory approval and the Company will not
be able to market them. Even if the
Companys product candidates meet safety and efficacy endpoints, regulatory
authorities may not approve them, the Company may not be able to successfully
market them, or the Company may face post-approval problems that require
withdrawal of its product from the market.
The Companys results may be affected by its effectiveness at managing
its financial resources, its ability to successfully develop and market its
product candidates, competition from other biotechnology and pharmaceutical
companies, difficulties or delays in manufacturing its products, and regulatory
developments involving current and future products. Delays in the initiation, progress or
completion in clinical trials, whether caused by competition, adverse events,
investigative site initiation rates, patential enrollment rates, regulatory
issues or other factors, could adversely affect the Companys financial
position and prospects. If the Company
is unable to raise additional capital when required or on acceptable terms, it
may have to significantly delay, scale back or discontinue one or more of its
drug development or discovery research programs. The Company is at an early stage of
development and may not ever have any products that generate significant
revenue.
All
information contained in the press release and this report on Form 8-K is
as of December 8, 2008. 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.
4
Section 9 Financial Statements and Exhibits
Item 9.01
Financial Statements and
Exhibits.
(d)
Exhibits
99.1
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Press
Release, dated December 6, 2008, entitled Two Pralatrexate Studies
Presented At The 50
th
Annual Meeting Of The American Society of
Hematology.
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99.2
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Press
Release, dated December 7, 2008, entitled
Allos Therapeutics
Announces Top Line Results From Pivotal Phase 2 Propel Trial Of Pralatrexate
In Patients With Relapsed Or Refractory Peripheral T-Cell Lymphoma.
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5
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:
December 8, 2008
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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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6
EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Press
Release, dated December 6, 2008, entitled Two Pralatrexate Studies
Presented At The 50
th
Annual Meeting Of The American Society of
Hematology.
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99.2
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Press
Release, dated December 7, 2008, entitled
Allos Therapeutics
Announces Top Line Results From Pivotal Phase 2 Propel Trial Of Pralatrexate
In Patients With Relapsed Or Refractory Peripheral T-Cell Lymphoma.
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7
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