Navigation Links
Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer
Date:3/23/2009

EXTON, Pa., March 23 /PRNewswire/ -- Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. Food and Drug Administration (FDA) has agreed to and approved the design of a single, pivotal, Phase III clinical trial evaluating farletuzumab (also known as MORAb-003) in platinum-sensitive ovarian cancer patients experiencing their first relapse. The agreement was made under the Special Protocol Assessment (SPA) procedure.

"We are pleased that the FDA has approved the protocol for this Phase III study of farletuzumab in first-relapsed, platinum-sensitive ovarian cancer," stated Martin D. Phillips, M.D., Chief Medical Officer of Morphotek. "Physicians and patients do not have many good choices for treating ovarian cancer at this stage, and we are hopeful that some day farletuzumab may provide an option for ovarian cancer patients and their caregivers."

Morphotek is currently concluding a Phase II trial with farletuzumab as a single-agent and in combination with standard-of-care chemotherapy (carboplatin and taxane) in platinum-sensitive ovarian cancer patients experiencing a first relapse of their disease. The trial was designed to measure objective rate of response, and to compare the length of a patient's second remission with her first remission. Interim results from the study demonstrated an encouraging rate of durable objective response in patients on combination therapy. These findings prompted pursuit of a definitive pivotal study to evaluate the capacity of farletuzumab to benefit patients with ovarian cancer in a rigorously controlled manner.

The Phase III study, the design of which was agreed to by FDA, will assess the capacity of farletuzumab to extend progression free survival and overall survival in combination with carboplatin and taxane at two different dose levels of farletuzumab. The study will be conducted as a randomized, double-blind, plac
'/>"/>

SOURCE Morphotek, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Eisai Corporation of North America Announces Appointment of Vice President of U.S. Corporate Communications
2. Eisai Inc. and the Alzheimers Association Introduce the C.A.R.E. Pharmacy Award and Call for Nominations
3. Eisai Renews Its Commitment to Responsible Healthcare Community Interactions in Accordance with the Revised PhRMA Marketing Code
4. Eisai Inc. Supports Acting Surgeon Generals Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism
5. Biologic Drugs, Particularly Centocor/Janssen-Cilags Stelara and Abbott/Eisais Humira, will Drive the Psoriasis Drug Market to $5 Billion by 2017
6. Eisai Will Initiate First Head-to-Head Study Comparing Dacogen(R) (decitabine for injection) and Vidaza(R) (azacitidine) in Patients with Myelodysplastic Syndromes
7. Eisai Inc. and the North American Thrombosis Forum (NATF)* Introduce the DVTeamCare(TM) Hospital Award and Call for Nominations
8. Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix(R)
9. Teikoku Pharma USA and Eisai Co., Ltd. Announce Licensing Agreement for a New 7-Day Transdermal Formulation of Donepezil.
10. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... For patients with asthma, just believing an odor is ... at least 24 hours, a new study indicates. ... you think you smell," study author Cristina Jaen, a ... in a Monell news release. "Asthmatics often ... that an odor is harmful, our bodies react as ...
(Date:7/30/2014)... the vast majority of kids with autism have abnormal ... from children who have trouble processing sensory stimuli, researchers ... be overly sensitive to sound, sight and touch. They ... lack of concentration. Complicating matters, some kids with ... trouble tolerating loud noises, like a vacuum. Others can,t ...
(Date:7/30/2014)... were breastfed for three months or more as ... inflammation associated with cardiovascular and metabolic diseases, according ... University in St. Louis. , "This study shows ... children,s health decades later," said Molly W. Metzger, ... a co-author of the study with Thomas W. ...
(Date:7/30/2014)... July 30, 2014 On July 29, ... the Indian Institute of Public Health, Gandhinagar released a ... India, Volume II: The Way Forward .” The report ... on Policies and Practices to Improve Nutrition Security in ... Father of the Green Revolution" and chair of the ...
(Date:7/30/2014)... “Today, we have said ¡Basta! (enough) to ... promoted to our children and our families. The SWEET ... industry to put the health of people first and ... Delgado, President and CEO of the National Alliance for ... Tax (SWEET) Act by Congresswoman Rosa L. DeLauro. , ...
Breaking Medicine News(10 mins):Health News:Even Thinking an Odor is Harmful May Spur Asthma Symptoms 2Health News:Different Areas of Brain Affected in Autism, Sensory Disorders 2Health News:Different Areas of Brain Affected in Autism, Sensory Disorders 3Health News:Birthweight and breastfeeding have implications for children's health decades later 2Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 2Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 3Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 4Health News:National Alliance for Hispanic Health Statement on Introduction of SWEET Act 2
... A study featured in the November issue of the ... simple questionnaire designed to identify patients at high risk of ... cases of cancer of the original 430 patients who qualified ... The study was conducted in primary care physician offices among ...
... ... with a compound that fights chronic liver disease Infections caused by Hepatitis C. Lloyd ... claim is incurable. The Blueberry Extract has a compound derived from blueberry leaves and ... , ...
... ... Targeted immunotherapy has been an attractive new therapeutic area for a ... cells without damaging surrounding normal tissue. New study results demonstrate high ... lymphoma associated with the Epstein-Barr virus (EBV-lymphoma) in patients who have ...
... ... its camera housings for underwater use, it turned to ZaGO Manufacturing Company for an answer. ... possibility of water leaking into the switch operating the camera. Vision Tech benefited from ... ...
... ... , ... -- Carmel Pharma, maker of the PhaSeal System for the safe handling of hazardous drugs, ... , , , , ,For safety and ease of use, the non-vented Secondary Set offers the ...
... November 2009 issue of the Journal of Thoracic Oncology ... and treatment may be attributed to health care system discrepancies. ... researchers studied the timing of lung cancer diagnosis and treatment ... patient population within two different hospital systems. David E. Gerber, ...
Cached Medicine News:Health News:Lloyd Wright's Alternative Medicine Marketing Only Blueberry Extract with 45% of Hepatitis C Inhibitor Proanthocyanidin 2Health News:Lloyd Wright's Alternative Medicine Marketing Only Blueberry Extract with 45% of Hepatitis C Inhibitor Proanthocyanidin 3Health News:Immunotherapy Demonstrates Long-Term Success in Treating Lymphoma 2Health News:Immunotherapy Demonstrates Long-Term Success in Treating Lymphoma 3Health News:Immunotherapy Demonstrates Long-Term Success in Treating Lymphoma 4Health News:ZaGO Manufacturing Company Seals the Deal -- Underwater 2Health News:Carmel Pharma Introduces PhaSeal Secondary Set (C60) 2
(Date:7/30/2014)... -- Research and Markets has announced the ... Industry Report 2014" report to their offering. ... Global and Chinese Aseptic Packaging Industry Report is a ... the global Aseptic Packaging industry with a focus on ... overview of the industry including definitions, classifications, applications and ...
(Date:7/30/2014)... PITTSBURGH , July 30, 2014   ... Markets Groups Inc.: OTC Pink: UPZS), a Delaware ... a distribution agreement with Larasan Pharmaceutical Corporation ("Larasan"), a ... products.  According to the agreement, US-based Larasan will ... gourmet 6" frozen pizza through Larasan,s vast distribution ...
(Date:7/30/2014)... and PARIS , July 30, 2014 ... and Sanofi (EURONEXT: SAN and NYSE: SNY ... trials of alirocumab in people with hypercholesterolemia met their ... baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks ... investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type ...
Breaking Medicine Technology:Global and Chinese Aseptic Packaging Industry Report 2014 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 4Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 5Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 6Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 7Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 8
... study shows 90-day statin drug claims filled through a mail ... supply from a retail pharmacy. The findings of the study ... management, will be presented at the Academy of Managed Care ... Minn. April 27-29. Waste occurs when patients stop ...
... /PRNewswire-Asia-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: ... diagnostic ("IVD") company, today announced that it will report ... ("4Q FY2010") and the full fiscal year ended March ... June 2, 2011. The Company will also ...
Cached Medicine Technology:For Patients on Statins, Study Finds Filling 90 Day Supply Prescriptions through Mail Service Compared to Retail Pharmacy is Associated with Less Waste 2China Medical Technologies to Announce Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2011 on June 2, 2011 2
... Medication Delivery., ,Designed for adolescent ... incorporates an additional lumen and injection ... the cuff., ,SHERIDAN offers three ... CO2 monitoring, pressure monitoring or medication ...
... For Laryngotracheal Instillation of Topical Anesthetic, ... populations, this cuffed tube incorporates an ... spray application of topical anesthetic above ... offers three endotracheal tubes designs which ...
... ,Designed for neonatal and pediatric patient ... monitoring lumen within the wall of the ... Luer lock connector bonded to lumen line ... monitoring or syringe irrigation of medication., ...
SPIRAL-FLEX® Oral Precut Reinforced Tubes...
Medicine Products: