Exhibit 99.1

 

 

 

PRESS RELEASE

 


Contacts:

Investor
Heather Rowe

720-540-5225

 

Media

Monique Greer

415-946-1075

 

 

ALLOS THERAPEUTICS REPORTS 2008 RESULTS

Conference Call Scheduled for Today at 4:15 p.m. ET —

 

WESTMINSTER, Colo., March 3, 2009

— Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported results for its fiscal year ended December 31, 2008 and outlined its key objectives for 2009.  For the year ended December 31, 2008, the Company reported a net loss of $51.7 million, or $0.69 per share, compared to a net loss of $39.4 million, or $0.60 per share, for 2007.  Net cash used in operating activities during 2008 was $42.9 million.  Cash, cash equivalents and investments in marketable securities as of December 31, 2008 totaled $84.0 million.

 

“During 2008, we made significant advancements in our pralatrexate product development and commercialization plan,” said Paul L. Berns, President and Chief Executive Officer.  “We recently reported final results from the PROPEL trial, which demonstrated that pralatrexate produced durable responses in heavily pre-treated patients.  Based on the results of the trial, we intend to submit an NDA for pralatrexate for the treatment of patients with relapsed or refractory PTCL in the first half of 2009.  We are also evaluating pralatrexate in other hematologic malignancies and solid tumor indications, including a Phase 2b study comparing pralatrexate and erlotinib in patients with advanced non-small cell lung cancer. We are pleased with patient enrollment in this study and now expect to complete patient accrual in the third quarter of this year.”

 

2008 and Recent Corporate Highlights

 

Pralatrexate (PDX)

 

·                  Reported final results from PROPEL trial

 

·                  Announced results from the Company’s pivotal Phase 2 PROPEL trial of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in February 2009.  The results of the trial demonstrated that 29 of 109 evaluable patients, or 27%, achieved a response as assessed by central independent oncology review, which is the primary endpoint of the trial.  The Kaplan-Meier estimate for the median duration of response was 287 days, or 9.4 months.  Duration of response is the key secondary endpoint of the trial.  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 17% of patients. Patients in the PROPEL trial were heavily pre-treated, having received a median of three prior systemic treatment regimens.  Based on these results, the Company intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pralatrexate for the treatment of patients with relapsed or refractory PTCL in the first half of 2009.  Pralatrexate has orphan drug designation and fast track designation in the

 


The following information was filed by Allos Therapeutics Inc (ALTH) on Tuesday, March 3, 2009 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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