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Allos Therapeutics Reports Third Quarter 2007 Financial Results
Date:11/5/2007

of 150 to 325 mg/m2 of PDX. The maximum tolerated dose (MTD) was determined to be 270 mg/m2, which is nearly twice that observed in a previous Phase 1 study in which PDX was administered without vitamin supplementation. Clinically significant radiologic responses were observed. Greater than 50% of patients (13/22) received 2 or more prior treatment regimens. Based on PDX clinical experience to date, the Company plans to initiate a randomized Phase 2 study of PDX in patients with NSCLC.

PDX in NHL (Phase 1/2)

In October 2007, additional interim data from the Company's on-going Phase 1/2 study of PDX in patients with non-Hodgkin's lymphoma (NHL) and Hodgkin's disease were presented at the 2007 AACR-NCI-EORTC conference. Responses were observed in 14 of 26 (54%) evaluable patients with T-cell lymphoma, with the duration of response typically exceeding the previously administered line of chemotherapy. No major safety concerns were identified in this heavily pre-treated population. These results are consistent with the interim data presented at the 2006 American Society of Hematology (ASH) meeting.

PDX In Vivo and In Vitro

In October 2007, results from a Company-sponsored pre-clinical study that investigated the mechanism of action of PDX and its differences from other antifolates, and compared the in vivo activity of PDX, methotrexate (MTX) and Alimta(R) against two NSCLC models were presented at the 2007 AACR-NCI-EORTC conference. The results suggest that PDX is mechanistically different from MTX and Alimta and that these differences may be due to enhanced uptake of PDX into the tumor cell and/or greater intracellular accumulation and polyglutamylation, resulting in greater inhibition of dihydrofolate reductase (DHFR). In addition, PDX induced greater tumor regression compared to MTX or Alimta in two human NSCLC xenograft models, including the highly aggressive H460 model.

RH1

RH1 is a novel small molecule chemotherapeutic agent that
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SOURCE Allos Therapeutics, Inc.
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