any life here?
two studies reported:
biz.yahoo.com
WESTMINSTER, Colo., Dec. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced the presentation of interim results from an ongoing Phase 1/2 trial of PDX (pralatrexate) in patients with non-Hodgkin's Lymphoma. Owen O'Connor, M.D., Ph.D., Attending Physician, Lymphoma Department, Memorial Sloan-Kettering Cancer Center (MSKCC) and the study's principal investigator, presented the findings in a poster presentation yesterday at the 47th Annual Meeting of the American Society of Hematology.
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"PDX has achieved a remarkably high complete response rate in a difficult to treat, drug resistant patient population," said Dr. O'Connor. "Results seen to date suggest that PDX may offer distinct advantages over current approaches used in the treatment of T-cell lymphoma."
biz.yahoo.com
Retrospective Analysis Finds EFAPROXYN(TM) Extends Survival With Quality of Life in Patients With Brain Metastases Originating From Breast Cancer
Monday December 12, 8:02 am ET
WESTMINSTER, Colo., Dec. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced the presentation of new findings from its Phase 3 clinical trial of the investigational radiation sensitizer EFAPROXYN(TM) (efaproxiral) in patients with brain metastases. Preliminary data from the Phase 3 study, called REACH, were first announced in April 2003. Charles Scott, Ph.D., CBS Squared, presented the findings in a poster presentation Saturday at the 28th Annual San Antonio Breast Cancer Symposium.
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In abstract #4040, titled "Improved Survival, Quality of Life (QOL), and Quality-Adjusted Survival (QAS) in Breast Cancer Patients Treated with Efaproxiral (EFAPROXYN(TM)) and Whole Brain Radiation Therapy (WBRT) for Brain Metastases," Dr. Scott presented a QAS analysis of data from the Company's Phase 3 REACH study, which compared the survival benefit of brain metastases patients receiving EFAPROXYN with WBRT to those receiving WBRT alone. Results of the analysis indicated that the addition of EFAPROXYN to WBRT led to a statistically significant increase in survival for EFAPROXYN-arm patients with brain metastases originating from breast cancer, which was accompanied by a statistically significant improvement in both QOL and QAS, a composite measure of quality and duration of survival. Specifically, EFAPROXYN-arm patients with brain metastases originating from breast cancer experienced a slower overall decline in Spitzer Quality of Life Index (SQLI) scores over time (p<0.001) relative to the control arm. SQLI is a 5-item questionnaire with overall score ranges from 0 (worse) to 10 (best)."
This study provides insight into the quality of life of long-term survivors of the REACH study," said Dr. Scott. "Importantly, the survival benefit realized by patients with brain metastases originating from breast cancer was not clinically compromised by a decline in quality of life."
About the Study
The REACH study was a randomized, open label Phase 3 clinical trial designed to demonstrate the safety and efficacy of EFAPROXYN in treating patients with brain metastases from various solid tumors and good performance status. Patients with small cell lung cancer, germ cell tumors or lymphoma were excluded. Prior brain tumor resection was allowed as long as measurable lesion(s) remained. The study enrolled 538 patients and compared the safety and efficacy of EFAPROXYN plus WBRT and supplemental oxygen (271 patients) versus WBRT and supplemental oxygen (267 patients) alone in patients with brain metastases. The primary endpoint of the trial was survival. Although the difference in overall survival between patients who received EFAPROXYN plus WBRT and patients who received WBRT alone was not statistically significant, the trial showed a positive survival benefit among patients with brain metastases originating from breast cancer. To further confirm the survival benefit observed in the breast cancer sub-group, in February 2004, the Company initiated a Phase 3, randomized, open-label, multi-center trial called ENRICH (Enhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), designed to compare the effect of WBRT with supplemental oxygen with or without EFAPROXYN in women with brain metastases from breast cancer. The Company currently expects to complete patient enrollment in the ENRICH trial during the second half of 2006 and report preliminary results approximately six months thereafter." |
