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Brain Cancer News for October 2004
Prognostic Factors Influencing Survival in Patients with Brain Metastases Identified in Largest Ever Randomized Study
ATLANTA, Oct. 4, 2004 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - News) 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. A retrospective analysis of the results from the study led to the identification of the strongest prognostic factors for survival in patients with brain metastases. John H. Suh, M.D., Clinical Director, Radiation Oncology, Brain Tumor Institute at the Cleveland Clinic Foundation and the study's lead investigator presented the findings in an oral presentation today at the 46th Annual Meeting of the American Society for Therapeutic Radiation Oncology. Preliminary data from the Phase 3 study, called REACH, were first announced in April 2003.
In abstract #60, titled "Prognostic Factors for Survival in Patients with Brain Metastases Enrolled on a Worldwide Phase 3 Randomized Trial of 538 Patients," Dr. Suh and colleagues evaluated certain factors influencing long-term survival of brain metastases patients, including Karnofsky Performance Status (KPS), site of primary, age, presence of extra cranial metastases, control of primary, gender, presence of liver metastases, timing of brain metastases diagnosis, prior brain tumor resection and number of brain metastases. Results of the analysis indicated that KPS, prior brain tumor resection, the presence of extra cranial metastases and gender were the strongest variables in predicting outcome. Moreover, the analysis affirmed the effectiveness of the study drug, EFAPROXYN, in improving survival time across a heterogeneous patient population.
"This study has significant implications for the design of future randomized trials in brain metastases patients," said Dr. Suh. "Our findings confirm the impact of certain variables in determining survival outcome for brain metastases patients. Moreover, the results demonstrated an improvement in survival for patients with brain metastases who received EFAPROXYN and whole brain radiation therapy (WBRT) with supplemental oxygen over those who received WBRT with supplemental oxygen only."
Results from Dr. Suh's retrospective analysis were incorporated into the study design of Allos' 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 whole brain radiation therapy (WBRT) with supplemental oxygen with or without EFAPROXYN in women with brain metastases from breast cancer. The trial, which was initiated in February 2004, incorporated certain identified prognostic factors into the stratification and design, including KPS and presence of liver metastases.
Study Design
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 and good performance status. Patients with SCLC, 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) in patients with brain metastases. The primary endpoint of the trial was survival.
About EFAPROXYN
EFAPROXYN is the first synthetic small molecule designed to "sensitize" hypoxic (oxygen-deprived) areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy in the treatment of cancer. By increasing tumor oxygenation at the time of treatment, EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy. Unlike chemotherapeutics or other radiation sensitizers, EFAPROXYN does not have to cross the blood brain barrier or enter the tumor to be effective.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The company's lead clinical candidate, EFAPROXYN, is a synthetic small molecule that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of standard radiation therapy. In addition, Allos is developing PDX (pralatrexate), a novel small molecule cytoxic injectable antifolate (DHFR inhibitor) intended to treat non-small cell lung cancer, mesothelioma and non-Hodgkin's lymphoma. For more information, please visit the company's web site at: www.allos.com.
Safe Harbor Statement
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 adequately demonstrate the safety and efficacy of EFAPROXYN for use as an adjunct to WBRT for the treatment of patients with brain metastases from breast cancer or any other solid tumor, and to obtain regulatory approval to market EFAPROXYN for this or any other indication, as well other risks and uncertainties detailed from time to time in the Company's SEC filings, including its Annual Report on Form 10-K, as amended, for the year ended December 31, 2003. [The company's product candidates are in various stages of development and may never be fully developed in a manner suitable for commercialization. If the company does not develop commercially successful products, its ability to generate revenue will be limited. If the company is unable to raise additional capital when required or on acceptable terms, it may have to significantly delay, scale back or discontinue one or more of its drug development programs. Delays in clinical trials, whether caused by adverse events, patient enrollment rates, regulatory issues or other factors, could adversely affect the company's financial position and prospects. Results from earlier clinical trials are not necessarily predictive of future clinical results. If the company is unable to generate meaningful amounts of revenue or cannot otherwise raise the necessary funds to support operations, it may not be able to continue as a going concern.] 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 assumes no responsibility to update such statements.
Source: Allos Therapeutics, Inc.
Semafore Pharmaceuticals Names Leading Cancer Researchers and Clinicians to Advisory Board
INDIANAPOLIS, Oct. 4, 2004 /PRNewswire/ -- Semafore Pharmaceuticals, Inc., an emerging leader in developing small molecule cancer therapies addressing critical cell signaling pathways, today announced a number of additions to its Scientific and Clinical Advisory Board. Together the new Advisory Board members represent a depth of academic expertise and medical and pharmaceutical experience in fields ranging from cell signaling to angiogenesis to neuro-oncology and prostate cancer. They include Michael Cowley, Ph.D., Richard DiMarchi, Ph.D., Gordon Mills, M.D., Ph.D., Ray Sawaya, M.D., Jonathan W. Simons, M.D., Howard R. Soule, Ph.D., Christopher J. Sweeney, M.B.B.S., and Alfred Yung, M.D.
"As a pioneer in the development of novel anti-cancer compounds that address the critical PI3K/PTEN pathway, Semafore is committed to recruiting a diverse, world class scientific and clinical advisory team," said Joseph Garlich, Ph.D., Semafore President and CSO. "This outstanding group already has been invaluable in helping us decipher which cancers have the highest potential of responding to our lead PI3K and PTEN inhibitors, and they are proving instrumental in supporting our goal of progressing the first targeted PI3 kinase inhibitor into human clinical trials next year."
Semafore's therapeutic programs are based on proprietary science related to the cell-signaling pathway PI3K/PTEN -- the primary, non-redundant controlling mechanism for multiple cellular functions that regulate the growth and survival of cancer cells. Semafore is developing proprietary molecules that represent a new generation of drugs to fight brain, prostate, breast, lung and several of the other estimated 20 or more cancer types that are dependent on the PI3K pathway.
"Based on solid preclinical data, Semafore's lead clinical candidate SF1126 is the first PI3K inhibitor to demonstrate impressive potential as an innovative new way to fight multiple cancers," said Dr. Donald Durden of Emory University and Senior Scientific Advisor to Semafore. Gordon Mills, M.D., Ph.D., Professor of Medicine at the MD Anderson Cancer Center added, "We are eager to assess this agent and Semafore's other pipeline compounds in clinical trials, and we will be working closely with Semafore to help facilitate that goal."
New Scientific and Clinical Advisory Board Member Biographies
Michael Cowley, Ph.D., is Director of Electrophysiology and Assistant Scientist in the Division of Neuroscience, Oregon National Primate Research Center. His research focus includes signal transduction and novel applications of electrophysiological studies. Dr. Cowley is the author of numerous articles, co-inventor on four patent applications and recipient of a number of awards. He is a co-founder and head of the Scientific Advisory Board of Orexigen Therapeutics. Dr. Cowley received a doctorate from the Faculty of Medicine, Prince Henry's Institute of Medical Research of Monash University in Australia and a B.S. degree from The University of Melbourne.
Richard DiMarchi, Ph.D., the Linda & Jack Gill Chair in Biomolecular Sciences and Professor of Chemistry at Indiana University, is a retired Group Vice President at Eli Lilly & Company, where for more than two decades he provided leadership for endocrine research and product development. Dr. DiMarchi is author of over 150 scientific publications and patents. He contributed significantly to the discovery of ground-breaking products like Humalog® and to the commercial development of Humulin®, Humatrope®, Glucagon®, Xigris®, Forteo®, and Evista®. Dr. DiMarchi, a co-founder of Ambrx, Inc, currently serves as its Chairman of the Board of Directors. He received his advanced academic training at Indiana University and the Rockefeller University.
Gordon Mills, M.D., Ph.D., an internationally recognized cancer expert and thought leader in signal transduction and the PI3-K pathway, is Chairman, Department of Molecular Therapeutics, Professor of Medicine and Ann Rife Chair in Gynecology at MD Anderson Cancer Center. Previously, he was a researcher and Associate Professor at the University of Toronto. Dr. Mills has published extensively on the role of signal transduction and molecular mechanisms in cancer. He received bachelors, medical and doctoral degrees from the University of Alberta in Canada.
Ray Sawaya, M.D., a leading expert in brain cancer, has been the Chairman of the Department of Neurosurgery at The University of Texas M.D. Anderson Cancer Center in Houston, Texas since the department was established in 1990. He is also the Director of the Brain Tumor Program at M.D. Anderson Cancer Center. Dr. Sawaya is internationally known for his work in the clinical management of patients with primary and metastatic brain tumors, as well as his research into the molecular mechanisms of brain cancer. He has published extensively and served as both reviewer and editor for a number of peer- reviewed journals. Dr. Sawaya completed his medical studies at St. Joseph University, in Beirut, Lebanon, followed by post-graduate work in the United States.
Jonathan W. Simons, M.D., is Director of the Winship Cancer Institute of Emory University and Professor, Hematology & Oncology, Emory University School of Medicine. Dr. Simons is an internationally recognized leader in molecular oncology and gene therapy for prostate cancer. Dr. Simons is a founding member and leader of the Prostate Cancer Foundation (PCF, formerly CaP CURE) and has served in leadership roles for the American Association of Cancer Research, American Society of Clinical Oncology, American Urological Association, National Cancer Institute of the National Institutes of Health, Department of Defense Biomedical Research Initiatives for Cancer, and the American Cancer Society. He and his postdoctoral fellows have received numerous research prizes. Dr. Simons is a B.S. graduate of Princeton University and received his M.D. degree from The Johns Hopkins University School of Medicine.
Howard R. Soule, Ph.D., is Executive Vice President and Chief Scientist at the Prostate Cancer Foundation (PCF, formerly CaP CURE) and an internationally recognized expert in cancer and cardiovascular drug research and development. He is responsible for coordinating scientific and clinical research, bringing together academia and industry to accelerate the discovery and development of new treatments for prostate cancer. Previously Dr. Soule was a senior R&D executive at Corvas International. He received bachelors and masters degrees from the University of Missouri, a Ph.D. from Baylor College of Medicine, and he was a Post Doctoral Fellow in Cancer Immunology at the Scripps Research Institute.
Christopher J. Sweeney, M.B.B.S., is a clinical investigator who focuses on early stage cancer drug development and is Assistant Professor in the Department of Medicine at Indiana University School of Medicine and Co- Director of the Experimental and Developmental Therapeutics Program at the Indiana University Cancer Center, with appointments in Hematology- Oncology and Clinical Pharmacology. He has played critical roles in the conduct of more than 25 Phase I cancer clinical trials and has authored or co-authored more than 40 papers in peer-reviewed journals, in addition to multiple monographs and book chapters. Dr. Sweeney received his medical degrees from the University of Adelaide, South Australia.
Alfred Yung, M.D., a leading expert and early stage clinical researcher in brain cancer, is Chairman, Department of Neuro-Oncology, and Margaret and Ben Love Chair of Clinical Cancer Care at M.D. Anderson Cancer Center. Dr. Yung's research focus is on cell cycle and anti-angiogenic approaches, as well as molecular therapy strategies, to combat cancer. He is principal investigator on NCI-sponsored Brain Tumor Consortium Phase I and Phase II trials of gene therapies and new anti-angiogenic agents, and is a scientific advisor to ABC2 (the Accelerate Brain Cancer Cure) Foundation. Dr. Yung is a board certified neurologist and completed his medical studies at the University of Chicago, Pritzker School of Medicine, followed by his internship and residency at the University of California at San Diego, and a post-graduate fellowship at Memorial Sloan-Kettering Cancer Center.
Semafore's Scientific and Clinical Advisory Boards are co-chaired by Dr. Garlich and Dr. Donald Durden of Emory University, an inventor of Semafore's intellectual property and now Senior Scientific Advisor to the company. Dr. Durden currently is Professor of Pediatric Oncology and Hematology at Emory University School of Medicine, and Scientific Director of Basic and Translational Research at the AFLAC Cancer Center & Blood Disorders Service of the Children's Healthcare of Atlanta and Emory University.
About Semafore
Semafore is an Indianapolis-based company discovering and developing small molecule cancer drugs to modulate critical cell signaling pathways. The company's programs leverage a breakthrough -- the discovery of the PI3K//PTEN pathway's role as the critical intercept point in cell signaling that controls angiogenesis, apoptosis, migration, invasion and metastasis. Semafore is establishing a leadership position in this important new area and has already produced a portfolio of high potential drug candidates. Semafore's lead clinical candidate is SF1126, a targeted PI3 Kinase inhibitor for cancer therapy. SF1126, which has shown broad anti-tumor activity against multiple cancers, is in pre-IND development and is expected to be the first PI3-K inhibitor to enter clinical trials, targeted for mid-2005. The company is also developing small molecule PTEN inhibitors, which have potential application in cancer and in diseases where safeguarding cell survival is crucial, including protection of the bone marrow during chemotherapy and to protect the heart from ischemia and reperfusion injury. Semafore's lead products are expected to have significant efficacy advantages compared to existing and developmental cancer therapies. For more information, see the company's Web site http://www.semaforepharma.com .
Contacts:
Semafore Pharmaceuticals, Inc. Media:
Derek A. Small Stephen Gendel
Director of Corporate Development GendeLLindheim BioCom Partners
(317) 876-3075 (212) 918-4650
Source: Semafore Pharmaceuticals, Inc.
(BW)(CA-SALMEDIX) Salmedix, Inc. Announces the Initiation of Two New Clinical Trials
SAN DIEGO--(BUSINESS WIRE)--Sept. 30, 2004--A New Phase II Studyof SDX-101 for Chronic Lymphocytic Leukemia, and a Cooperative Group Study of SDX-102 for Brain Cancer
Salmedix, Inc. announced today the initiation of two new clinical studies. A new Phase II clinical study of SDX-101, or R-etodolac, for patients with Chronic Lymphocytic Leukemia ("CLL") has begun enrolling patients in Sweden, Germany and the UK, and is expected to begin enr olling in France and Poland in the near future.Thisstudy is an open-label, randomized Phase II clinical trial in which 80 patients with CLL will receive a standard chlorambucil regimen alone or in combination with SDX-101 for multiple cycles. Response rate, using standardized response criteria, will be the primary endpoint.
Duration of response will also be evaluated
"In this new study, we are investigating the utility of SDX-101 in combination with chlorambucil, which is currently one of the regimens used as frontline therapy in CLL patients," stated Pratik Multani, MD, VP of clinical development for the company.
"The study is based on data from a previous clinical trial of SDX-101 as a single agent which was presented at the 2003 American Society of Hematology annual meeting by Dr. Markus Jensen from the University of Cologne, Germany.
In that dose escalation study in patients with CLL, a total of 43 patients in groups of six to eight were treated twice daily with increasing doses of SDX-101 for up to eight weeks.
This prior trial demonstrated clinical activity with an acceptable safety profile.
A greater than 25% reduction in absolute lymphocyte count, or ALC, was observed in 73% of patients receiving SDX-101 at doses equal to or greater than 1000 mg twice per day.
The maximal ALC decline averaged 48% and typically occurred within four weeks of starting treatment
Following cessation of SDX-101 therapy, ALC generally returned to pre-treatment values.
The company believes that this return to pre-treatment values suggests the need for longer duration therapy or use of SDX-101 in combination with other agents active in CLL.
In this prior eight-week study, SDX-101 was generally well tolerated with the majority of adverse events defined as mild or moderate, defined as Grade 1 or 2." On September 17, 2004, a Phase I/II clinical study of SDX-102, or l-alanosine, in patients with previously treated brain tumors was initiated by the New Approaches to Brain Tumor Therapy, or NABTT, a consortium funded by the National Cancer Institute.
As the sponsor of the trial, Salmedix is providing clinical supplies of SDX-102 and will be responsible for regulatory filings.
NABTT will conduct this trial independently under a standard clinical trial research agreement
Salmedix has another Phase II trial under way with SDX-102 in advanced stage patients with non-small cell lung cancer, pancreatic cancer, mesothelioma, soft tissue sarcoma and osteosarcoma who have generally failed one or two prior drug regimens
About Salmedix, Inc
Salmedix is an oncology drug development company with a commercial focus on the treatment of hematologic malignancies, or blood cancers, with three clinical-stage product candidates, Treanda(TM), SDX-101 and SDX-102.
Salmedix maintains its corporate headquarters in San Diego, California
Forward-Looking Statements Salmedix cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Salmedix that any of its plans will be achieved. Forward-looking statements include statements related to the ability to enroll the patient numbers required for each trial, that future clinical trial results will support prior findings, or that such future clinical trial results will support regulatory approvals required to market a commercial drug.
Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Salmedix's business including, without limitation, difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products, unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims, the scope and validity of patent protection for its products, competition from other companies, and its ability to obtain additional financing to support its operations.
All forward-looking statements are qualified in their entirety by this cautionary statement, as well as the factors disclosed in the Company's filings with the U.S. Securities and Exchange Commission Salmedix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof
CONTACT: Salmedix, Inc
David S. Kabakoff, Ph.D. or
Anita I. Busquets
858-622-5050
KEYWORD: CALIFORNIA SWEDEN GERMANY UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL BIOTECHNOLOGY PRODUCT
SOURCE: Salmedix, Inc
© CompanynewsGroup
Ecopia Presents Positive Cancer Data on ECO-4601 at the 16th EORTC-NCI-AACR Symposium
MONTREAL--(BUSINESS WIRE)--Oct. 1, 2004--Ecopia BioSciences Inc. (TSX:EIA) presented data on ECO-4601 in a poster entitled "A new antitumour compound, ECO-4601: Preclinical evaluation and in vivo efficacy in glioma" at the 16th EORTC-NCI-AACR Symposium in Geneva today. The poster showed results from efficacy and bioavailability trials on the Company's lead anticancer compound, which are significant in showing that ECO-4601 is a potentially effective chemotherapeutic agent in treating primary brain cancer.
Data from trials in mouse models demonstrated that Ecopia's lead anticancer compound increases survival and decreases tumour growth in an aggressive form of primary brain cancer. Additional data showed that ECO-4601 could be administered intravenously resulting in a rapid distribution to the brain. These results confirm previous data demonstrating that the compound crosses the blood-brain barrier, regardless of the route of administration.
"The data presented today clearly show that ECO-4601 is a promising new treatment for primary brain tumours. In addition, the results also confirm that this compound can be easily administered to patients using conventional intravenous infusion thereby avoiding the use of invasive techniques which can lead to serious complications," stated Dr. Pierre Falardeau, Ecopia's President and Chief Executive Officer.
The poster included efficacy results based on tests performed in orthotopic C6 glioma tumours and treated with ECO-4601 as well as bioavailability data from tests done using various routes of administration on CD1 mouse models. Detectable levels of ECO-4601 were observed in the brain regardless of the route of administration. Additional data suggests that intravenous dosing is the preferred route of administration.
A copy of the poster is available on Ecopia's website.
About the primary brain cancer market
Current prognosis for patients diagnosed with primary brain cancer is poor, with a two-year survival rate of 35%, dropping as low as 8% for some more aggressive forms. Each year 8.2 out of every 100,000 individuals are diagnosed with primary brain cancer, representing an estimated 58,000 new cases per year in developed countries. Presently, the standard of care involves surgery to remove the tumour when accessible, followed by radiation to shrink the tumour and chemotherapy to kill the cancer cells. The current chemotherapeutic standard of care for brain cancer costs an estimated US$25,000 per year, resulting in a potential market worth well over US$1 billion.
About the 16th EORTC-NCI-AACR Symposium
The revolution in understanding the molecular basis of cancer has lead to the discovery and development of numerous innovative agents - 'designer' diagnostics, new prognostic tests, 'smart' drugs and other entirely novel ways of tackling cancer.
To bring these new developments to patients as quickly and efficiently as possible requires international collaboration, early and optimal exchange of information, good quality translational research, efficient drug development and large prospective clinical trials.
Three of the world's leading cancer organisations:
- The European Organisation for Research and Treatment of Cancer;
- The USA's National Cancer Institute;
- The American Association for Cancer Research;
Have joined forces to provide a platform for presentation of the latest findings in drug research and development to around 2,000 international experts in the field.
All data at the four-day meeting held in Geneva from September 28 to 1 October are being presented for the first time.
About Ecopia
Using its DECIPHER(R) technology, Ecopia has built a pipeline that includes several anticancer, antibacterial and antifungal agents now in early stages of development. The Company is advancing its most promising compound ECO-4601, a potential new drug to treat brain cancer, through preclinical trials and expects to file an IND in 2005. With its innovative DECIPHER(R) technology, Ecopia uses a radically different approach to discover new drugs from bacteria called actinomycetes. The most promising discoveries are added to the Company's rapidly growing pipeline for further development. Ecopia's shares are listed on the Toronto Stock Exchange (ticker symbol: EIA).
Additional information about the Company can be obtained from Ecopia's website at www.ecopiabio.com.
This press release may contain forward-looking statements that reflect the Company's current expectations regarding future events. The forward-looking statements, including expectations as to the pharmaceutical potential of ECO-4601 and the timeframe for its development involve risk and uncertainties. Actual events could differ materially from those projected here and depend on a number of factors, including the results of continuing pre-clinical profiling of ECO-4601, uncertainties related to the regulatory process for drug development, the success and timely completion of clinical studies, and trials, and the impact of general economic conditions. Investors are cautioned against placing undue reliance on forward-looking statements. A more complete discussion of the risks and uncertainties facing the Company appears in Ecopia's 2003 Annual Report.
DECIPHER(R) is a trademark of Ecopia BioSciences Inc.
Contacts
Ecopia BioSciences Inc.
Karen Eugeni
Director, Communications
(514) 336-2700 ext. 404
eugeni@ecopiabio.com
www.ecopiabio.com
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