ALTH Allos Therapeutics, Inc. (MM)

Allos Therapeutics, Inc. (Nasdaq:ALTH) announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of cutaneous T-cell lymphoma (CTCL). The Company is currently investigating pralatrexate in a Phase 1 clinical study in patients with relapsed or refractory CTCL. In addition, the Company plans to conduct a Phase 3 clinical study comparing FOLOTYN in combination with systemic bexarotene versus systemic bexarotene alone in patients with CTCL who are refractory to at least one prior systemic therapy. 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, which the Company plans to initiate in 2010. The EC previously granted orphan designations for pralatrexate for the treatment of patients with peripheral T-cell lymphoma (PTCL) and non-papillary transitional cell carcinoma (TCC) of the urinary bladder, a form of bladder cancer.

“This orphan medicinal product designation further strengthens our global development strategy for pralatrexate in patients with T-cell lymphomas,” said Paul L. Berns, president and chief executive officer of Allos Therapeutics. “CTCL is a devastating condition that greatly impacts patients’ lives. To date, pralatrexate has demonstrated encouraging evidence of clinical activity in patients with relapsed or refractory CTCL and we look forward to continuing to advance the pralatrexate development program in this difficult-to-treat patient population.”

The European orphan medicinal product designation is intended to promote the development of drugs that may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious. Under EC legislation, orphan medicinal product designation provides ten years of potential market exclusivity once the product candidate is approved for marketing for the designated indication in the European Union. Orphan medicinal product designation also allows for protocol assistance free of charge on clinical trials, a reduced Marketing Authorisation Application (MAA) filing fee and the potential for grant funding. This designation is based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

About Cutaneous T-Cell Lymphoma (CTCL)

Cutaneous T-cell lymphoma, or CTCL, is comprised of a number of indolent non-Hodgkin’s T-cell lymphomas which have their primary manifestations in the skin. The most common CTCL subtypes are mycosis fungoides and Sézary syndrome. According to the Lymphoma Research Foundation, CTCL accounts for approximately 2% to 3% of the estimated 66,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the United States. The estimated annual prevalence of CTCL is 16,000 - 20,000 cases in the U.S., 51,000 cases in the European Union2, and 3,000 cases in Canada.1

About Allos Therapeutics

Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN® (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is the first and only drug approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The FDA approved FOLOTYN under the agency’s accelerated approval process. Allos is also developing FOLOTYN in other potential indications. Allos retains exclusive worldwide rights to FOLOTYN for all indications. Allos is headquartered in Westminster, Colo. For additional information, please visit www.allos.com.

Safe Harbor Statement

This press release contains 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 regarding the Company’s intent to develop and conduct clinical trials for pralatrexate for the treatment of patients with relapsed or refractory CTCL; 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, that the Company may experience difficulties or delays in the initiation, progress or completion of its clinical trials, whether caused by competition, adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that the Company may lack the financial resources and access to capital to fund ongoing or planned clinical trials for pralatrexate or any of its other product candidates, or to continue evaluating their therapeutic utility in other potential indications. 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 Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, and in the Company's 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 press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

Sources:

1Cutaneous Lymphoma Foundation. CTCL-MF Fast Facts. http://clfoundation.org/publications/CL_fast_facts.pdf. Accessed March 19, 2010.

2European Medicines Agency Committee for Orphan Medicinal Products Public Summary of Opinion on Orphan Designation.

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