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Allos Updates Phase II Results for RSR13 in Non-Small Cell Lung Cancer At ASTRO Meeting (PR Newswire) ...Median tumor progression free survival time in the radiation portal was 24.8 months while median progression......``We have also learned through our Phase II studies in metastatic brain tumors and primary brain cancer that RSR13 has broad treatment implications,... - Nov 06 4:59 AM ET


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Posted on: 11/06/2001

"Yahoo - Allos Updates Phase II Results for RSR13 in Non-Small Cell Lung Cancer At ASTRO Meeting"
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Tuesday November 6, 5:00 am Eastern Time

Press Release

SOURCE: Allos Therapeutics, Inc.

Allos Updates Phase II Results for RSR13 in Non-Small Cell Lung Cancer At ASTRO Meeting

- Results Demonstrate Positive Median Survival Time With Addition of RSR13 -

SAN FRANCISCO, Nov. 6 /PRNewswire/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - news) today announced updated positive survival results from a Phase II clinical trial evaluating the use of RSR13 in patients with locally advanced, inoperable, non-small cell lung cancer receiving radiation therapy following induction chemotherapy. The updated study results showed a median survival rate of 20.6 months, 1-year survival rate of 68 percent and an estimated 2-year survival rate of 43 percent. Data from this study were presented today at the 43rd Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO).

RSR13 (generic name: efaproxiral sodium) is a synthetic small molecule that increases the release of oxygen from hemoglobin and has the potential to enhance the effectiveness of standard radiation therapy.

This open-label, multi-center Phase II study was led by Hak Choy, M.D., Clinical Director, Center for Radiation Oncology, Vanderbilt-Ingram Cancer Center. "Non-small cell lung cancer is very aggressive and difficult to treat. A median survival of 20.6 months is very encouraging, considering the results from the relevant comparison group for this study showed 13.7 months," said Dr. Choy. "These updated results further suggest that RSR13 should continue to be studied and evaluated as a treatment for this type of cancer."

The study was conducted in 47 evaluable patients with locally advanced, inoperable, stage IIIA/IIIB non-small cell lung cancer. The objectives of this study were to evaluate overall survival, progression-free interval in the chest, complete and partial response rates in the chest (radiation portal) and time to disease progression outside of the radiation portal. The patients received two courses of induction paclitaxel and carboplatin chemotherapy followed by daily RSR13 combined with chest radiation therapy for 32 doses.

Median time to first progression was 9.9 months. Median tumor progression free survival time in the radiation portal was 24.8 months while median progression free survival time outside the portal was 11.3 months.

"The results from this Phase II study of RSR13 in combination with radiation therapy provide evidence that RSR13 has the potential to delay tumor progression and increase survival in patients with advanced non-small cell lung cancer," said Stephen J. Hoffman, M.D., Ph.D, President and Chief Executive Officer of Allos. "We have also learned through our Phase II studies in metastatic brain tumors and primary brain cancer that RSR13 has broad treatment implications, impacting survival time of patients with various forms of cancer."

RSR13 Clinical Trials

Allos Therapeutics is currently evaluating initiation of a Phase III clinical study of RSR13 in patients with Stage III non-small cell lung cancer. Currently, the Company is conducting a Phase III randomized study called R.E.A.C.H. (Radiation Enhancing Allosteric Compound for Hypoxic brain metastases) evaluating the safety and efficacy of RSR13 and whole brain radiation therapy in metastatic brain cancer. Recruitment is currently underway and completed enrollment is expected during the second half of 2002. RSR13 has been designated Fast Track status by the Food and Drug Administration (FDA).

Non-Small Cell Lung Cancer

Lung and bronchial cancer are the most common causes of cancer deaths in the United States. An estimated 169,500 new cases of lung cancer will be diagnosed this year, which account for 13 percent of all cancer diagnoses. Non-small cell lung cancer is the most common lung cancer, accounting for almost 80 percent of lung cancer cases.

About Allos Therapeutics and RSR13

Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule drugs for improving cancer treatments. The Company is conducting a pivotal Phase III trial for the treatment of metastatic brain tumors with its lead clinical candidate, RSR13. RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin, the oxygen carrying protein contained within red blood cells. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy and some chemotherapy agents in the treatment of cancer. By increasing tumor oxygenation, RSR13 has the potential to enhance the efficacy of standard radiation therapy and certain chemotherapeutic drugs. Unlike chemotherapeutics or other radiosensitizers, RSR13 does not have to cross the blood brain barrier and enter the tumor for efficacy. Enhancement of oxygen release from hemoglobin to oxygenate the tumor is the means of enhancing the effectiveness of radiation therapy and chemotherapy. For more information about the Company, please consult www.allos.com

This announcement contains forward-looking statements that involve risks and uncertainties. Future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to the Company's ability to complete its clinical trials on schedule and in accordance with regulatory requirements, repeat positive interim results in later clinical trials, adequately demonstrate the safety and efficacy of RSR13 for the treatment of brain metastases, non-small cell lung cancer or any other type of cancer, as well as other risks and uncertainties detailed from time to time in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2000. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company assumes no responsibility to update such statements.

SOURCE: Allos Therapeutics, Inc.

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