- Amended Current report filing (8-K/A)
10 Novembre 2008 - 11:09PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
Amendment
No. 1
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 10, 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)
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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))
INFORMATION TO BE INCLUDED IN THE REPORT
In accordance with General Instruction B.2. of Form 8-K,
the information presented in this filing and furnished in the exhibit attached
hereto 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.
Explanatory Note
On November 10, 2008, Allos Therapeutics, Inc. (the
Company) filed a Form 8-K (the Original Report) reporting that four
abstracts describing results from pralatrexate (PDX) studies have been accepted
for presentation at the 50th Annual Meeting of the American Society of
Hematology (ASH), to be held December 6-9, 2008, in San Francisco,
California. Item 7.01 of the Original
Report contained a typographical error by incorrectly stating that the incidence
of grade 3/4 thrombocytopenia observed in the first 65 evaluable patients
enrolled in the PROPEL trial was 23% instead of 31%. Accordingly, this Form 8-K/A is filed for the
purpose of fixing such typographical error.
The Original Report is hereby amended and restated in its entirety as
follows:
Section 7 Regulation FD
Item 7.01 Regulation FD Disclosure.
On November 10, 2008, Allos Therapeutics, Inc.
(the Company) issued a press release announcing
that four abstracts describing results from pralatrexate (PDX) studies have
been accepted for presentation at the 50th Annual Meeting of the American
Society of Hematology (ASH), to be held December 6-9, 2008, in San
Francisco, California. The press release is attached hereto as Exhibit 99.1
and is incorporated herein by reference.
1. The abstract entitled
PROPEL: A Multi-center Phase 2 Open-label Study of Pralatrexate (PDX)
with Vitamin B12 and Folic Acid Supplementation in Patients with Relapsed or
Refractory Peripheral T-cell Lymphoma (PTCL)
presents interim response and safety data from the Companys
pivotal Phase 2 PROPEL trial of pralatrexate (PDX) in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL).
The abstract reports interim data for the first 65 evaluable patients
enrolled in the trial. Patients were
considered evaluable if they received at least one dose of pralatrexate and their
diagnosis of PTCL was confirmed by independent review. Twenty-nine percent (n=19) of the first 65 evaluable patients experienced
either a complete or partial response, as assessed by central independent
oncology review. Forty-five percent
(n=29) of the first 65 evaluable patients experienced either a complete or
partial response, as assessed by the PROPEL investigators. The table below sets forth the efficacy
results as assessed by central independent oncology review. Thirty-seven
percent (n=7) of the 19 patients who responded to pralatrexate according to
central independent oncology review experienced a complete response (CR). Four patients had insufficient response data
and nine patients could not be assessed for response because they discontinued
treatment prior to completion of cycle 1, although these patients are included
in the denominator for purposes of determining the objective response rate
(ORR).
Efficacy Results According to Central Review
Endpoint
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Value
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Pralatrexate (N=65)
n (%)
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Total
# responders/ORR
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CR/PR
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19 (29)
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Best
Response
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CR
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7 (11)
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PR
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12 (18)
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SD
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16 (25)
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PD
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17 (26)
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Insufficient
data
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4 (6)
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Discontinuation
prior to assessment
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9 (14)
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Of the 19 patients who responded to pralatrexate
according to central independent oncology review, 17 patients had evaluation by
positron emission topography (PET) scan.
Eight of these patients were deemed to have a complete response and nine
were deemed to have a partial response. Of the first 65 evaluable patients,
twenty-two percent (n=14) received pralatrexate for
>
6 months. The
median duration of response for these patients could not be estimated due to
the current length of follow up.
The most
common drug related grade 3/4 adverse events were mucositis and
thrombocytopenia, which were observed in 14% and 31% of patients, respectively.
Patients received a median of three prior treatment regimens.
From August 2006 to April 2008, 115
patients were enrolled in the PROPEL trial, 107 of whom are considered
evaluable for response according to the trial protocol. The trial is fully accrued and all patients
enrolled in the trial will continue to be followed for long-term survival. A
portion of the foregoing interim response and safety data were previously
reported by the Company in a press release dated May 15, 2008.
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2. The abstract entitled
A Phase 1/2a Open-label
Study of Pralatrexate and Gemcitabine in Patients with Relapsed or Refractory
Lymphoproliferative Malignancies
presents interim data from the
Companys ongoing Phase 1/2a open-label, multi-center study of
pralatrexate and gemcitabine with vitamin B
12
and folic acid
supplementation in patients with relapsed or refractory non-Hodgkins lymphoma
(NHL) or Hodgkins disease. As of August 2008,
20 patients had been treated in this study.
Preliminary efficacy data showed six patients (30%) achieved a partial
response, including five patients on a sequential dosing schedule and one
patient on a same day dosing schedule. Treatment
group A included patients who received a schedule of pralatrexate, followed the
next day by gemcitabine, once weekly for 3 out of 4 weeks. This schedule was not well tolerated as
evidenced by the incidence of grade 3/4 hematological toxicities. Treatment group B included patients who
received a schedule of pralatrexate, followed the next day by gemcitabine, once
every two weeks. The maximum tolerated
dose for this sequential dosing schedule was established as 10 mg/m
2
of pralatrexate, followed by 300 mg/m
2
of gemcitabine, once every
two weeks. Treatment group C included
patients who received pralatrexate, followed one hour later by gemcitabine,
once every two weeks. Dose escalation
was ongoing on the same day dosing schedule as of the date of the
abstract. The interim data suggest that
pralatrexate and gemcitabine may have an acceptable safety profile when
administered on a schedule of once every two weeks. Patients received a median of three prior
systemic regimens.
3. The
abstract entitled
Pralatrexate (PDX) is Active in Cutaneous T-Cell Lymphoma: Preliminary
Results of a Multi-center Dose-finding Trial
presents interim data
from the Companys ongoing Phase 1 trial of pralatrexate in patients with
relapsed or refractory cutaneous T-cell lymphoma. From August 2007 to August 2008, 23 patients were
enrolled in the trial, 17 of whom were evaluable for safety and response as of
the date of the abstract. Preliminary
efficacy data showed nine patients (53%) who achieved a response, including
seven partial responses and two complete responses. In addition, six patients
had stable disease. Seven patients remained on treatment as of the date of the
abstract, including three patients who had been on treatment for 8, 8 and 9
months, respectively. The most common
treatment-related adverse event was mucositis.
There were no Grade 4 toxicities and no thrombocytopenia above Grade
1. Patients received a median of 3.5
prior systemic therapies.
4. The abstract entitled
Pralatrexate (PDX)
Complements the Activity of the Proteasome Inhibitor Bortezomib (B) in In
Vitro Model of Lymphoid T-Cell Malignancies
presents data from a
pre-clinical study of a combination of pralatrexate and Velcade®
(bortezomib). This study
investigated the
in vitro and/or in vivo activity of pralatrexate and bortezomib alone or in combination in different T-cell lymphoma and leukemia cell lines. The
results of the study suggest that PDX and bortezomib may be synergistic in in vitro models of human T-cell lymphoma.
The information contained in the press release and
this report on Form 8-K should be considered in the context of our filings
with the Securities and Exchange Commission and other public announcements that
we may make, by press release or otherwise, from time to time. Some of the matters discussed in the press
release and this report on Form 8-K contain forward-looking statements
that involve significant risks and uncertainties, including potential synergies
between PDX and bortezomib in in vitro models of human T-cell lymphoma, and
other statements which are other than statements of historical facts. Actual results could differ materially from those
projected and we caution investors not to place undue reliance on the
forward-looking statements contained in, or made in connection with, the press
release or this report on Form 8-K.
Results from clinical studies, including the Companys
study of PDX discussed in the abstracts described above, 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 PDX, 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 November 10, 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.
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Section 9 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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99.1
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Press
Release, Dated November 10, 2008, Entitled Four Pralatrexate (PDX)
Studies to be Presented at the 50
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Annual Meeting of the American
Society of Hematology; Top Line Results from Pivotal Phase 2 PROPEL Trial
Selected for Oral Presentation on December 8, 2008.
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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: November 10,
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 & Secretary
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EXHIBIT
INDEX
Exhibit No.
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Description
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99.1
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Press
Release, Dated November 10, 2008, Entitled Four Pralatrexate (PDX)
Studies to be Presented at the 50
th
Annual Meeting of the American
Society of Hematology; Top Line Results from Pivotal Phase 2 PROPEL Trial
Selected for Oral Presentation on December 8, 2008.
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