Abbott's molecular diagnostics business, headquartered in Des Plaines, Ill.,has entered into an agreement with Pfizer Oncoloy, a business unit of Pfizer Inc, committed to the discovery, investigation and development of innovative treatment options for cancer patients worldwide, to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements.
Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumors and a wide variety of other cancers, but not in normal cells, must be present.
Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.
"We are very pleased to partner with Abbott to develop a companion diagnostic test for non-small cell lung cancer and ensure its global availability for patients and physicians who need this information to make the best treatment decisions," said Garry Nicholson, General Manager, Pfizer Oncology Business Unit.
"This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate. Working in close partnership with the experienced Abbott team, we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC."
"Pfizer's novel compound for treating non-small cell lung cancer appears to be ideally suited to individualized therapy," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "Abbott is a leader in the development and commercialization of companion diagnostics and we're delighted to collaborate with Pfizer, a leader in cancer therapeutics, on the development of a test to identify patients who might benefit from this important compound."
Showing posts with label Molecular Oncology. Show all posts
Showing posts with label Molecular Oncology. Show all posts
Monday, August 31, 2009
Friday, January 9, 2009
Zoledronic Acid May Have Anti-Tumor Properties
Early evaluations of the bisphosphonate zoledronic acid (Zometa® , Novartis Oncology) suggest a possible direct anti-tumor effect when combined with neoadjuvant chemotherapy in breast cancer treatment, according to data presented to scientists and other medical professionals gathered at the Henry B. Gonzales Convention Center in San Antonio to hear and present the latest scientific findings in breast cancer research during the CTRC-AACR San Antonio Breast Cancer Symposium (December 10-14, 2008 ).
There is substantial in vitro evidence that zoledronic acid has direct antitumour effects and synergy with chemotherapy agents. Bisphosphonates may therefore be an adjuvant therapeutic strategy of potential importance.
‘Zoledronic acid is primarily targeted to bone and metastasis within the bone marrow microenvironment, but it may also be enhancing the response in the primary breast tumor,’ explained Robert Coleman, M.D., FRCP, professor of medical oncology at the University of Sheffield in the United Kingdom.
Coleman is the lead researcher on the AZURE (Adjuvant Zoledronic Acid to Reduce Recurrence) trial, a prospective, randomised, open label, parallel group trial designed to to evaluate the effect of zoledronic acid on breast cancer. ‘Although the larger AZURE trial is still being evaluated, if the findings in this smaller study are confirmed, the effect could be practice changing,' Coleman said.
The AZURE trial opened to recruitment in September 2003. Patients were recruited from 176 centres worldwide, completing accrual in January 2006, 8 months ahead of schedule, and enrolled 3,360 women with stage II/III breast cancer. The trial was set up to determine whether adjuvant treatment with 4 mg zoledronic acid in addition to adjuvant or neoadjuvant chemotherapy would improve the disease-free and bone metastasis-free survival of women with breast cancer at high risk of relapse.
Analysis of the characteristics of the study population shows that both groups are well
matched across all criteria. 51% of patients have T2 tumour at presentation, with 76.6% being ER positive. 60.6% and 33.2% had 1-3 and ≥4 axillary nodes involved respectively and 6.4% were treated in the neoadjuvant setting. Anthracyclines were administered to 92.6% and 22.7% received taxanes, in large part due to accrual into the TANGO trial concurrent with AZURE. Only 4.6% received endocrine therapy alone. Almost half of the patients (44.6%) were premenopausal at randomisation.
Coleman and colleagues performed a retrospective pathology analysis on 205 patients who received neoadjuvant chemotherapy to determine zoledronic acid’s impact on the primary tumor. Zoledronic acid appeared to reduce tumor size from 30 mm in the chemotherapy alone group to 20.5 mm in the combination group.
After adjusting for variables like estrogen receptor status and treatment duration, the difference remained at 42.4 mm in the chemotherapy group and 28.2 mm in the combination group. The pathological complete response rate was 5.8 percent in the chemotherapy arm and 10.9 percent in the zoledronic acid group.
The number of patients requiring mastectomy was 77.9 percent in the chemotherapy group and 65.3 percent in the combination group. ‘Zoledronic acid is currently approved for the treatment of bone metastasis and osteoporosis. If the AZURE trial remains positive, then we’ll file for an additional indication,’ Coleman said.
For more information, read:
There is substantial in vitro evidence that zoledronic acid has direct antitumour effects and synergy with chemotherapy agents. Bisphosphonates may therefore be an adjuvant therapeutic strategy of potential importance.
‘Zoledronic acid is primarily targeted to bone and metastasis within the bone marrow microenvironment, but it may also be enhancing the response in the primary breast tumor,’ explained Robert Coleman, M.D., FRCP, professor of medical oncology at the University of Sheffield in the United Kingdom.
Coleman is the lead researcher on the AZURE (Adjuvant Zoledronic Acid to Reduce Recurrence) trial, a prospective, randomised, open label, parallel group trial designed to to evaluate the effect of zoledronic acid on breast cancer. ‘Although the larger AZURE trial is still being evaluated, if the findings in this smaller study are confirmed, the effect could be practice changing,' Coleman said.
The AZURE trial opened to recruitment in September 2003. Patients were recruited from 176 centres worldwide, completing accrual in January 2006, 8 months ahead of schedule, and enrolled 3,360 women with stage II/III breast cancer. The trial was set up to determine whether adjuvant treatment with 4 mg zoledronic acid in addition to adjuvant or neoadjuvant chemotherapy would improve the disease-free and bone metastasis-free survival of women with breast cancer at high risk of relapse.
Analysis of the characteristics of the study population shows that both groups are well
matched across all criteria. 51% of patients have T2 tumour at presentation, with 76.6% being ER positive. 60.6% and 33.2% had 1-3 and ≥4 axillary nodes involved respectively and 6.4% were treated in the neoadjuvant setting. Anthracyclines were administered to 92.6% and 22.7% received taxanes, in large part due to accrual into the TANGO trial concurrent with AZURE. Only 4.6% received endocrine therapy alone. Almost half of the patients (44.6%) were premenopausal at randomisation.
Coleman and colleagues performed a retrospective pathology analysis on 205 patients who received neoadjuvant chemotherapy to determine zoledronic acid’s impact on the primary tumor. Zoledronic acid appeared to reduce tumor size from 30 mm in the chemotherapy alone group to 20.5 mm in the combination group.
After adjusting for variables like estrogen receptor status and treatment duration, the difference remained at 42.4 mm in the chemotherapy group and 28.2 mm in the combination group. The pathological complete response rate was 5.8 percent in the chemotherapy arm and 10.9 percent in the zoledronic acid group.
The number of patients requiring mastectomy was 77.9 percent in the chemotherapy group and 65.3 percent in the combination group. ‘Zoledronic acid is currently approved for the treatment of bone metastasis and osteoporosis. If the AZURE trial remains positive, then we’ll file for an additional indication,’ Coleman said.
For more information, read:
- Winter MC, Thorpe HC, Burkinshaw R, Beevers SJ, Coleman RE. The addition of zoledronic acid to neoadjuvant chemotherapy may influence pathological response exploratory evidence for direct anti-tumor activity in breast cancer. Abstract 5101. Poster Session V: Treatment: Neoadjuvant Therapy. San Antonio Breast Cancer Symposium.
Also read:
- Click here for full prescribing information.
- The Institute of Cancer Research
Also read PubMed Abstracts:
- Lyseng-Williamson KA. Zoledronic Acid: a review of its use in breast cancer. Drugs. 2008;68(18):2661-82
- Brufsky A. Management of cancer-treatment-induced bone loss in postmenopausal women undergoing adjuvant breast cancer therapy: a Z-FAST update. Semin Oncol. 2006 Apr;33(2 Suppl 7):S13-7.
Thursday, January 8, 2009
Upcoming Phoenix conference highlights 'molecular oncology' for oncologists and their patients
Physician-scientists from the Arizona based Translational Genomics Research Institute (TGen), a non-profit organization dedicated to conducting groundbreaking medical research in with life changing results, and Scottsdale Healthcare, a primary clinical research site for TGen in the Virginia G. Piper Cancer Center in Scottsdale, AZ, will present their latest findings and techniques at a national conference designed to provide cancer doctors with new treatments for their patients.
'Molecular Oncology: The Sixth Vital Sign, What Every Oncologist Should Know' is intended to help oncologists provide better diagnosis, early detection as well as drugs and other treatments that in some cases can slow the growth or even shrink tumors.
'Given the explosion of new information on the genetic and cellular features of malignancy, the modern oncologist must master the significance and application of cancer-related sciences,' said Dr. Ramesh K. Ramanathan, Medical Director of TGen Clinical Research Services at Scottsdale Healthcare, a partnership between TGen and Scottsdale Healthcare Corp.
Personalized Medicine
Beyond the five vital signs of pulse, respiration, temperature, blood pressure and pain, is a new sixth 'vital sign' – molecular therapeutics. This new 'vital sign' offers oncologists the opportunity to identify the causes of disease at the molecular level in order to provide the right drugs in the right amounts at the right times for the specific needs of individual patients. This new approach is becoming better known in health circles as personalized medicine or theragnostics.
However, the the concept that information about a patient's genotype or gene expression profile can be used to tailor medical care to an individual's needs requires understanding of the link between the mechanisms of action of novel therapeutics and specific tumor geneticts, thereby unifying molecular diagnostics and therapeutics.
Given the explosion of new information on the genetic and cellular features of malignancy and the rapidly growing armamentarium of targeted therapeutics, oncologists today must master the understanding, appreciate the significance and value the application of cancer-related basic and clinical sciences. 'This gap in knowledge and its application in clinical practice will be addressed in this conference,' Ramanathan explained.
Dr. Ramanathan is the co-program director of the conference, along with Dr. Daniel Von Hoff, TGen's Physician-In-Chief and the Chief Scientific Officer at TCRS. Both doctors conduct groundbreaking personalized-medicine research and clinical drug trials at TCRS in Scottsdale, and both are on the clinical faculty of the University of Arizona College of Medicine. Both will present at the conference.
Other TGen and Scottsdale Healthcare scientists scheduled to present include: Dr. Jeffrey Trent, TGen's President and Scientific Director; Dr. Raoul Tibes, Director of the Hematological Malignancies Program at TCRS and an Associate Investigator at TGen; Dr. Stephen P. Anthony, Chief Medical Officer of TGen Drug Development Services (TD2) and a Senior Investigator at TGen; Dr. John Carpten, Director of TGen’s Integrated Cancer Genomics Division and a Senior Investigator at TGen; and Gayle Jameson, M.S.N., Director of Supportive Care at TCRS and an Associate Investigator at TGen.
Target audience
Besides oncologists, the target audience includes all physicians and health professionals involved in caring for cancer patients, and researchers interested in new cancer diagnostics and therapeutics.
Key objectives of the conference include:
'Molecular Oncology: The Sixth Vital Sign, What Every Oncologist Should Know' is intended to help oncologists provide better diagnosis, early detection as well as drugs and other treatments that in some cases can slow the growth or even shrink tumors.
'Given the explosion of new information on the genetic and cellular features of malignancy, the modern oncologist must master the significance and application of cancer-related sciences,' said Dr. Ramesh K. Ramanathan, Medical Director of TGen Clinical Research Services at Scottsdale Healthcare, a partnership between TGen and Scottsdale Healthcare Corp.
Personalized Medicine
Beyond the five vital signs of pulse, respiration, temperature, blood pressure and pain, is a new sixth 'vital sign' – molecular therapeutics. This new 'vital sign' offers oncologists the opportunity to identify the causes of disease at the molecular level in order to provide the right drugs in the right amounts at the right times for the specific needs of individual patients. This new approach is becoming better known in health circles as personalized medicine or theragnostics.
However, the the concept that information about a patient's genotype or gene expression profile can be used to tailor medical care to an individual's needs requires understanding of the link between the mechanisms of action of novel therapeutics and specific tumor geneticts, thereby unifying molecular diagnostics and therapeutics.
Given the explosion of new information on the genetic and cellular features of malignancy and the rapidly growing armamentarium of targeted therapeutics, oncologists today must master the understanding, appreciate the significance and value the application of cancer-related basic and clinical sciences. 'This gap in knowledge and its application in clinical practice will be addressed in this conference,' Ramanathan explained.
Dr. Ramanathan is the co-program director of the conference, along with Dr. Daniel Von Hoff, TGen's Physician-In-Chief and the Chief Scientific Officer at TCRS. Both doctors conduct groundbreaking personalized-medicine research and clinical drug trials at TCRS in Scottsdale, and both are on the clinical faculty of the University of Arizona College of Medicine. Both will present at the conference.
Other TGen and Scottsdale Healthcare scientists scheduled to present include: Dr. Jeffrey Trent, TGen's President and Scientific Director; Dr. Raoul Tibes, Director of the Hematological Malignancies Program at TCRS and an Associate Investigator at TGen; Dr. Stephen P. Anthony, Chief Medical Officer of TGen Drug Development Services (TD2) and a Senior Investigator at TGen; Dr. John Carpten, Director of TGen’s Integrated Cancer Genomics Division and a Senior Investigator at TGen; and Gayle Jameson, M.S.N., Director of Supportive Care at TCRS and an Associate Investigator at TGen.
Target audience
Besides oncologists, the target audience includes all physicians and health professionals involved in caring for cancer patients, and researchers interested in new cancer diagnostics and therapeutics.
Key objectives of the conference include:
- Explaining the molecular and cellular features of malignancy in diagnostic and therapeutic approaches to the treatment of cancer, and identifying new diagnostic tools.
- Assessing the effects and early clinical results of new, targeted drug therapies on solid tumors and malignant blood cancers.
- Identifying new drug therapies that optimize treatment results and minimize side effects in specific biologic and clinical scenarios.
- Evaluating clinical trials and translational methods of care and their proper use in clinical decision-making and patient management.
The conference is sponsored by TGen, Scottsdale Healthcare's Virginia G. Piper Cancer Center and Physicians' Education Resource (PER) of Dallas. The conference is certified for Continuing Medical Education.
For more information:
- 'The Sixth Vital Sign' runs Jan. 22-24, 2009 at the Arizona Grand Resort.
- Personalized Medicine Coalition
Also read PubMed abstracts:
- Acharya CR, Hsu DS, Anders CK, Anguiano A, et al. Gene expression signatures, clinicopathological features, and individualized therapy in breast cancer. JAMA 2008 Apr 2;299(13):1574-87. Click here for a full text version of this article.
- Pene F, Courtine E, Cariou A, Mira JP. Toward theragnostics. Crit Care Med. 2009 Jan;37(1 Suppl):S50-8.
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