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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

WESTMINSTER, Colo. -- Allos Therapeutics, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ALTH) today announced the presentation of interim data from its Phase 1 study of PDX PDX Product Data Exchange (file name extension; XML technology)
PDX Paradox Files (file name extension)
PDX Product Definition Exchange
PDX Phone Data Exchange (Proxon) 
 (pralatrexate) with vitamin B vitamin B
n.
1. Vitamin B complex.

2. A member of the vitamin B complex, especially thiamine.



vitamin B, vitamin B complex

a group of water-soluble substances described separately.
12 and folic acid folic acid: see coenzyme; vitamin.
folic acid
 or folate

Organic compound essential to animal growth and health and needed by bacteria as a growth factor.
 supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma Cutaneous T-Cell Lymphoma Definition

Cutaneous T-cell lymphoma (CTCL) is a malignancy of the T-helper (CD4+) cells of the immune system.
Description
 (CTCL CTCL Cutaneous T Cell Lymphoma ), at the 10th International Conference on Malignant Lymphoma malignant lymphoma
n.
See lymphoma.
 in Lugano, Switzerland, June 4-7, 2008.

Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15 - 30 mg/m2 as part of a weekly schedule for two or three weeks followed by one week of rest. Patients received a median of three prior systemic therapies.

In this Phase 1 dose optimization study, investigator-assessed responses were observed in seven of 14 evaluable patients (50%), including two complete responses and five partial responses. Responses were observed in all four treatment cohorts.

The most common adverse event was mucositis, with Grade 2 mucositis observed in six of 17 patients and Grade 3 mucositis observed in two of 17 patients. There were no Grade 4 toxicities and no thrombocytopenia Thrombocytopenia Definition

Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets.
 above Grade 1.

"We are encouraged by these data, in which PDX has shown activity at a range of doses in patients with relapsed or refractory CTCL," said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "The study will continue with the objective of determining the optimal dose and schedule for PDX in this patient population."

The interim data were presented in a poster session on Thursday, June 5, 2008. To view a copy of the poster, visit the "Presentations" page under the "Investor/Media" section of the Company's website at www.allos.com.

In this Phase 1 open-label multi-center study, patients with either relapsed or refractory CTCL receive PDX as part of a weekly schedule for two or three weeks followed by one week of rest. In the first cohort, patients received starting doses of PDX at 30 mg/m2, with dose reduction in subsequent cohorts based on toxicity. Up to 56 evaluable patients will be enrolled in the study with the objective of determining the optimal dose and schedule for PDX in this patient population. A total of 20 of these patients will be enrolled at what is determined to be the optimal dose and schedule. Steven Horwitz, M.D., Assistant Attending Physician, Lymphoma Service, Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New , is serving as the study chair.

Information regarding this study is available at the U.S. government's clinical trials database at http://www.clinicaltrials.gov.

About Cutaneous T-Cell Lymphoma

Cutaneous cutaneous /cu·ta·ne·ous/ (ku-ta´ne-us) pertaining to the skin.

cu·ta·ne·ous
adj.
Of, relating to, or affecting the skin.


Cutaneous
Pertaining to the skin.
 T-cells lymphomas, or CTCLs, are comprised of a number of non-Hodgkin's T-cell lymphomas, including mycosis fungoides and Sezary syndrome, which have their primary manifestations in the skin. According to the Lymphoma Research Foundation, CTCL accounts for approximately 2% to 3% of the estimated 63,000 new cases of non-Hodgkin's lymphoma diagnosed each year in the United States. The Company estimates the current annual prevalence of CTCL in the United States is between 16,000 and 20,000 cases.

About PDX (pralatrexate)

PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR DHFR Dihydrofolate reductase, see there , a folic acid (folate folate /fo·late/ (fo´lat)
1. the anionic form of folic acid.

2. more generally, any of a group of substances containing a form of pteroic acid conjugated with l-glutamic acid and having a variety of substitutions.
)-dependent enzyme involved in the building of nucleic acid, or DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. The Company believes these biochemical features, together with preclinical and clinical data in a variety of tumors, suggest that PDX may have a favorable safety and efficacy profile relative to methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma.  and certain other DHFR inhibitors. The FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 has granted orphan drug status and fast track designation to PDX for the treatment of patients with T-cell lymphoma.

About Allos Therapeutics, Inc.

Allos Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for the treatment of cancer. The Company's lead product candidate, PDX (pralatrexate), is a novel antifolate currently under evaluation in a pivotal Phase 2 (PROPEL) trial in patients with relapsed or refractory peripheral T-cell lymphoma. The PROPEL trial is being conducted under an agreement reached with the U.S. Food and Drug Administration under its special protocol assessment, or SPA process. The Company is also investigating PDX in patients with non-small cell lung cancer Lung Cancer, Non-Small Cell Definition

Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
Description

There are two kinds of lung cancers, primary and secondary.
 and a range of lymphoma sub-types. The Company's other product candidate is RH1, a targeted chemotherapeutic agent currently under evaluation in a Phase 1 trial in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ). For additional information, please visit the Company's website at 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such forward-looking statements include statements regarding the potential safety and efficacy profile of PDX for the treatment of CTCL or any other type of cancer; the potential safety and efficacy profile of PDX relative to methotrexate and other related DHFR inhibitors; 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 Company may experience delays in the completion of the Phase 1 CTCL study, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that clinical trials may not demonstrate that PDX is both safe and effective for the treatment of patients with relapsed or refractory CTCL or any other type of cancer; that the interim data from the Phase 1 CTCL study may not be confirmed upon full analysis of the detailed results of the study, and may not be predictive of future clinical trial designs or results; and that the Company may lack the financial resources and access to capital to fund future clinical trials for PDX 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 Company's Annual Report on Form 10-K for the year ended December 31, 2007 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.
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Date:Jun 5, 2008
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