Allos Therapeutics Inc - Current report filing (8-K)
June 06 2008 - 6:04AM
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):
June 6, 2008
(June 5, 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
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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))
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.
Section 7 Regulation FD
Item 7.01 Regulation FD Disclosure.
On June 5, 2008, Allos Therapeutics, Inc.
(the Company) issued a press release
announcing interim data from a Phase 1 study of PDX with vitamin B12 and folic
acid supplementation in patients with relapsed or refractory cutaneous T-cell
lymphoma (CTCL) that was presented as a poster during the 10
th
International Conference on Malignant Lymphoma held June 4-7, 2008 in
Lugano, Switzerland. The press release is
attached hereto as Exhibit 99.1 and the poster, as presented, is attached
hereto as Exhibit 99.2, both of which are incorporated herein by reference
and may also be used in meetings with investors and analysts after the
date hereof and possibly with immaterial modifications. The fact that the poster is being furnished
should not be deemed an admission as to the materiality of any information
contained therein. The information contained
in the poster 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
poster contain forward-looking statements that involve significant risks and
uncertainties, including the determination of the optimal dosing of PDX for
patients with CTCL, 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 the posters.
Results from clinical studies, including the Companys
study of PDX discussed in the poster attached hereto as Exhibit 99.2, 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 poster is as of June 5,
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.
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 June 5, 2008, Entitled Allos Therapeutics Announces
Interim Data from Phase 1 Study of PDX in Patients with Relapsed or
Refractory Cutaneous T-Cell Lymphoma; Responses Observed in 50% of First 14
Evaluable Patients.
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99.2
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Poster
entitled Low-Dose Pralatrexate (PDX) is Active in Cutaneous T-cell Lymphoma:
Preliminary Results of a Multi-Center Dose Finding Trial.
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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.
Dated: June 6, 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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3
EXHIBIT
INDEX
Exhibit No.
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Description
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99.1
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Press
Release, Dated June 5, 2008, Entitled Allos Therapeutics Announces
Interim Data from Phase 1 Study of PDX in Patients with Relapsed or
Refractory Cutaneous T-Cell Lymphoma; Responses Observed in 50% of First 14
Evaluable Patients.
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99.2
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Poster
entitled Low-Dose Pralatrexate (PDX) is Active in Cutaneous T-cell Lymphoma:
Preliminary Results of a Multi-Center Dose Finding Trial.
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4
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