"The landscape of oncolgy continues to evolve as the results from studies are evaluated. All of us at http://www.cancereducation.com are pleased to provide coverage of these critical issues in oncology through our attendance at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, from June 4–8.
With over 30,000 oncology professionals gathering to discuss the latest innovations in research, quality of life issues, practice, and technology in the oncology community, our staff will attend several of the education and scientific sessions at ASCO.
Their daily updates will be posted on our blog* which can be accessed by clicking on the link at the top of the http://www.cancereducation.com home page."
Tuesday, June 01, 2010
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol - MarketWatch
Note: these results have been awaited since late last year as per past blogged postings (pending compilation of data)
press release
June 1, 2010, 8:31 a.m. EDT · Recommend · Post:
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol
SYDNEY, AUSTRALIA and SAN DIEGO, CA, Jun 01, 2010 (MARKETWIRE via COMTEX) -- Marshall Edwards, Inc., an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. "However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.
"Previously reported results of a Phase 2 trial," continued Dr. Gold, "which tested the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, demonstrated a 30% response rate (6 out of 20) compared to less than 1% (1 out of 142) in the OVATURE study in which phenoxodiol was administered orally. In addition, we remain excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.
"Lastly, I want to take this opportunity to personally thank the patients and their families for their participation in this trial. I would also like to thank the clinical investigators and trial coordinators for their dedication and support."
Safety Outcomes
As previously noted, phenoxodiol had a good safety profile and was well tolerated. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher.
About OVATURE and the Phenoxodiol Clinical Program
The OVATURE ("OVArian TUmor REsponse") trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April 2009 at which time 142 patients had been randomized to the study. Changes in standards of care over the period of the trial and the stringency of inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and consequently the Company deemed it prudent not to continue the trial to completion. The Independent Data Monitoring Committee (IDMC) supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.
About Phenoxodiol
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
Phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, S-1-P content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics. In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol has been granted Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
press release
June 1, 2010, 8:31 a.m. EDT · Recommend · Post:
Marshall Edwards Announces Final Results From Halted Phase 3 Clinical Trial of Phenoxodiol
SYDNEY, AUSTRALIA and SAN DIEGO, CA, Jun 01, 2010 (MARKETWIRE via COMTEX) -- Marshall Edwards, Inc., an oncology company focused on the clinical development of novel anti-cancer therapeutics, announced today that a final analysis of its Phase 3 OVATURE trial of orally administered phenoxodiol in women with recurrent ovarian cancer determined that the trial did not show a statistically significant improvement in its primary (progression-free survival) or secondary (overall survival) endpoints. As previously announced, the trial was closed for recruitment before completion of enrolment with only 142 out of a planned 340 patients enrolled.
This multi-center, randomized, double-blind trial assessed the safety and efficacy of daily phenoxodiol in combination with weekly carboplatin versus weekly carboplatin with placebo in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy.
"Owing to the fact that this trial was significantly underpowered due to the small number of patients enrolled, we were disappointed, but not entirely surprised by the final outcome," said Dr. Daniel P. Gold, newly appointed Chief Executive Officer of Marshall Edwards. "However, we remain confident that our investigational isoflavone platform, including triphendiol, a potentially more potent, second-generation analogue of phenoxodiol, may be of benefit to women with ovarian cancer, particularly when administered intravenously.
"Previously reported results of a Phase 2 trial," continued Dr. Gold, "which tested the activity of intravenous phenoxodiol plus weekly cisplatin in a similar platinum-resistant or refractory patient population, demonstrated a 30% response rate (6 out of 20) compared to less than 1% (1 out of 142) in the OVATURE study in which phenoxodiol was administered orally. In addition, we remain excited with the progress of another product candidate in our pipeline, NV-128, a novel isoflavone analogue with a mode of action distinct from both phenoxodiol and triphendiol.
"Lastly, I want to take this opportunity to personally thank the patients and their families for their participation in this trial. I would also like to thank the clinical investigators and trial coordinators for their dedication and support."
Safety Outcomes
As previously noted, phenoxodiol had a good safety profile and was well tolerated. The number of patients experiencing at least one adverse event was similar in each treatment group, as was the number of patients experiencing adverse events of Grade 3 or higher.
About OVATURE and the Phenoxodiol Clinical Program
The OVATURE ("OVArian TUmor REsponse") trial was a multi-center international Phase 3 clinical trial of orally administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs to determine its safety and effectiveness when used in combination with carboplatin.
The trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The study was closed to enrolment in April 2009 at which time 142 patients had been randomized to the study. Changes in standards of care over the period of the trial and the stringency of inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and consequently the Company deemed it prudent not to continue the trial to completion. The Independent Data Monitoring Committee (IDMC) supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.
About Phenoxodiol
Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.
Phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, S-1-P content is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cell death via caspase expression and promoting sensitivity to other chemotherapeutics. In laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs. Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.
Phenoxodiol has been granted Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process. Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure's Chief Executive Officer - MarketWatch
June 1, 2010, 8:00 a.m. EDT · Recommend · Post:
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure's Chief Executive Officer
HASSELT, Belgium, Jun 01, 2010 (BUSINESS WIRE) -- MabCure, Inc. /quotes/comstock/11k!mbci (MBCI 0.32, -0.01, -3.03%) :
Dear Shareholders:
I am pleased to update you on the progress of our research and development.
Over the past several months we have been working intensively on advancing our various programs with an emphasis on melanoma and ovarian cancer diagnostics. We consider these two projects near-term in their respective development stages, as I describe below.
In January 2010, we announced the commencement of our clinical trials at the Ramathibodi Hospital in Bangkok, Thailand to evaluate the potential of our panel of monoclonal antibodies (MAbs) to diagnose ovarian cancer in high risk patients. Since the study began, patients have been recruited at a solid pace and in line with our schedule. In addition, we are privileged that the Thai National Cancer Institute has decided to join our study and is currently reviewing our study protocol. The study is estimated to be completed within 5-6 months, as originally planned.
In parallel to our study in Thailand, we are planning to commence a study in collaboration with a major medical center in Belgium of several hundred blood samples which were obtained from patients over the past several years. The purpose of this "retrospective" study is to provide additional proof of the ability of our MAbs to correctly diagnose ovarian cancer, and is of considerable importance given the significant number of blood samples to be tested.
The study will be "blind" to all involved (i.e. the samples will be coded and neither the clinicians nor MabCure scientists will know the identity of the specimens until the study is complete), so as to prevent any bias in the analysis of the results. The study is expected to last several weeks and will commence once a formal agreement has been signed with the Belgian medical center. As a prelude to this study, we conducted a pilot study on a limited number of these "retrospective" specimens to calibrate the optimal technical conditions for our MAbs.
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure's Chief Executive Officer
HASSELT, Belgium, Jun 01, 2010 (BUSINESS WIRE) -- MabCure, Inc. /quotes/comstock/11k!mbci (MBCI 0.32, -0.01, -3.03%) :
Dear Shareholders:
I am pleased to update you on the progress of our research and development.
Over the past several months we have been working intensively on advancing our various programs with an emphasis on melanoma and ovarian cancer diagnostics. We consider these two projects near-term in their respective development stages, as I describe below.
In January 2010, we announced the commencement of our clinical trials at the Ramathibodi Hospital in Bangkok, Thailand to evaluate the potential of our panel of monoclonal antibodies (MAbs) to diagnose ovarian cancer in high risk patients. Since the study began, patients have been recruited at a solid pace and in line with our schedule. In addition, we are privileged that the Thai National Cancer Institute has decided to join our study and is currently reviewing our study protocol. The study is estimated to be completed within 5-6 months, as originally planned.
In parallel to our study in Thailand, we are planning to commence a study in collaboration with a major medical center in Belgium of several hundred blood samples which were obtained from patients over the past several years. The purpose of this "retrospective" study is to provide additional proof of the ability of our MAbs to correctly diagnose ovarian cancer, and is of considerable importance given the significant number of blood samples to be tested.
The study will be "blind" to all involved (i.e. the samples will be coded and neither the clinicians nor MabCure scientists will know the identity of the specimens until the study is complete), so as to prevent any bias in the analysis of the results. The study is expected to last several weeks and will commence once a formal agreement has been signed with the Belgian medical center. As a prelude to this study, we conducted a pilot study on a limited number of these "retrospective" specimens to calibrate the optimal technical conditions for our MAbs.
Activism among exceptional patients with cancer. [Support Care Cancer. 2010] - PubMed result
Abstract
BACKGROUND: The "exceptional patients" with cancer are survivors who had advanced cancer considered incurable by medical report and who subsequently became disease-free or experienced unexplained survival time given the nature of their disease or treatment. This experience is a puzzling phenomenon that has not been formally investigated in a cancer population. The purpose of this study was to understand exceptional patients' accounts of their experience.
MATERIALS AND METHODS: This study used a narrative approach with a cross-case thematic analysis. Recruitment took place at health care centers in the USA and Israel. Oncologists in both centers were asked to identify patients who had an exceptional disease course. Patients were then contacted and interviewed; an audio recording was made of each narrative account and then transcribed. Interviews and thematic analyses were conducted independently at each site. These thematic findings from each site were discussed with both research teams and a common underlying theme was identified, which is the focus of this report.
RESULTS: Twenty-six participants were interviewed: 14 from the USA and 12 from Israel. All the participants have had advanced disease with a range of diagnoses that included breast, colorectal, pancreatic, ovarian cancer, glioblastoma multiforme, and others. The main recurrent theme from both the US and Israeli sites was personal activism. This was manifested in taking charge and getting involved in the process of diagnosis and treatment, as well as becoming more altruistic in their relationships with others. In many cases, this was reflected in a change in a philosophy about life
CONCLUSIONS: In this study, we found that activism was a major theme that was independently observed in both Israel and the USA. This has implications for health care providers to facilitate patient engagement in the care and treatment of their disease. Further research on this phenomenon is needed.
BACKGROUND: The "exceptional patients" with cancer are survivors who had advanced cancer considered incurable by medical report and who subsequently became disease-free or experienced unexplained survival time given the nature of their disease or treatment. This experience is a puzzling phenomenon that has not been formally investigated in a cancer population. The purpose of this study was to understand exceptional patients' accounts of their experience.
MATERIALS AND METHODS: This study used a narrative approach with a cross-case thematic analysis. Recruitment took place at health care centers in the USA and Israel. Oncologists in both centers were asked to identify patients who had an exceptional disease course. Patients were then contacted and interviewed; an audio recording was made of each narrative account and then transcribed. Interviews and thematic analyses were conducted independently at each site. These thematic findings from each site were discussed with both research teams and a common underlying theme was identified, which is the focus of this report.
RESULTS: Twenty-six participants were interviewed: 14 from the USA and 12 from Israel. All the participants have had advanced disease with a range of diagnoses that included breast, colorectal, pancreatic, ovarian cancer, glioblastoma multiforme, and others. The main recurrent theme from both the US and Israeli sites was personal activism. This was manifested in taking charge and getting involved in the process of diagnosis and treatment, as well as becoming more altruistic in their relationships with others. In many cases, this was reflected in a change in a philosophy about life
CONCLUSIONS: In this study, we found that activism was a major theme that was independently observed in both Israel and the USA. This has implications for health care providers to facilitate patient engagement in the care and treatment of their disease. Further research on this phenomenon is needed.
Medical News: Hand Hygiene in Hospitals Not Up to Par - in Infectious Disease, Infection Control from MedPage Today
Each year, an estimated 2.5 million patients in the U.S. develop
healthcare-associated infections that result in 90,000 deaths and cost
the healthcare system an estimated $4.5 to $5.7 billion dollars
Anti-MUC1 Antibodies and Ovarian Cancer Risk: Prospective Data from the Nurses' Health Studies — Cancer Epidemiology, Biomarkers & Prevention
Note: MUC1 has been/is being studied in numerous cancers
Conclusion: Anti-MUC1 (glycoprotein) antibodies evaluated several years before diagnosis may be associated with lower risk of subsequent ovarian cancer in women <64 years old at assessment.
Conclusion: Anti-MUC1 (glycoprotein) antibodies evaluated several years before diagnosis may be associated with lower risk of subsequent ovarian cancer in women <64 years old at assessment.
May 20th, 2010 SGO statement - (U.S.) statement - House Defense Appropriations Subcomittee
Note: clicking above uploads directly the pdf file version
Statement of Daniel L. Clarke-Pearson, M.D. President - Society of Gynecologic Oncologists Professor and Chair, Obstetrics and Gynecology University of North Carolina Medical School Chapel Hill, North Carolina On Behalf of The Society of Gynecologic Oncologists Before The House Defense Appropriations Subcommittee
Thursday, May 20, 2010 at 10:00 am
Statement of Daniel L. Clarke-Pearson, M.D. President - Society of Gynecologic Oncologists Professor and Chair, Obstetrics and Gynecology University of North Carolina Medical School Chapel Hill, North Carolina On Behalf of The Society of Gynecologic Oncologists Before The House Defense Appropriations Subcommittee
Thursday, May 20, 2010 at 10:00 am
SGO E-Learning Center
SGO's 41st Annual Meeting on Women's Cancer Webcast Available Now!
FREE Introduction to Presidential Address, Cornelius Granai, MD
FREE Presidential Address, David Mutch, MD
FREE ACS Lectureship, Paul Goodfellow, PhD
FREE Introduction to Presidential Address, Cornelius Granai, MD
FREE Presidential Address, David Mutch, MD
FREE ACS Lectureship, Paul Goodfellow, PhD
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