Navigation Links
Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Date:9/6/2007

suming that the sponsor follows the protocol agreed-upon with the Agency, the sponsor has provided appropriate information to the Agency to support the protocol, the sponsor and the Agency agree to modify the protocol or a substantial scientific issue is identified after clinical testing has begun. In the absence of these developments, "completion of a SPA with FDA provides binding agreement relative to design and analysis of key Phase 3 trial(s) such that positive final results can lead to full NDA/ BLA approval." For more information about the Agency's Special Protocol Assessment process, see, http://www.fda.gov/cder/guidance/3764fnl.htm.

About Tanespimycin

Tanespimycin has been shown to induce apoptosis of drug-sensitive and drug-resistant multiple myeloma cell lines. Tanespimycin also inhibits expression of various cell surface cytokines, such as IGF-1R and IL-6R, that are involved in growth, survival and drug resistance of multiple myeloma cells. When used in combination with bortezomib, the destabilization of client proteins with tanespimycin while blocking their degradation with bortezomib promotes the accumulation of cytotoxic proteins, leading to cell death.

Kosan reported data from a Phase 1b trial of tanespimycin in combination with bortezomib at the 2007 annual meeting of the American Society for Clinical Oncology (ASCO) on 56 patients enrolled in 7 dose cohorts (100-340 mg/m2 of tanespimycin; 0.7-1.3 mg/m2 of bortezomib; tanespimycin administered via 1-hour infusion following the bortezomib dose 2 times per week every 2 weeks out of 3 weeks). Of these 56 patients, all had received multiple prior chemotherapy regimens (median of 4) and 67% had received bone marrow transplants.

In those patients who received tanespimycin across the range of doses tested and a dose of 1.0 or 1.3 mg/m2 of bortezomib, the overall response rate including complete, partial and mini
'/>"/>

SOURCE Kosan Biosciences Incorporated
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Kosan Presents Promising Phase 1 Data on Second-Generation Hsp90 Inhibitor, Alvespimycin, Showing Antitumor Activity in Refractory Breast and Ovarian Cancers at ASCO
2. Kosan Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Epothilone KOS-1584 at ASCO
3. Kosan Presents Data on Lead Hsp90 Inhibitor, Tanespimycin, Showing Promising Antitumor Activity in Multiple Myeloma at ASCO
4. Kosan Presents Preliminary Phase 2 Data Showing Antitumor Activity of Hsp90 Inhibitor Tanespimycin in Metastatic Melanoma at ASCO
5. Kosan Presents Preclinical Data on Nuclear Export Inhibitors, Novel Anticancer Agents, at AACR
6. Kosan Presents Preclinical Antitumor and Safety Data On Next-Generation Epothilone KOS-1803 at AACR
7. Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor Tanespimycin (KOS-953) at AACR
8. Kosan Announces Data Presentations at Upcoming AACR Annual Meeting
9. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
10. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
11. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)...  The board of directors of VirtualScopics, Inc. (NASDAQ: ... trial imaging solutions, today announced that James Groff ... immediately.  Mr. Groff has held the role of acting ... in January 2006 as an accounting manager and was ... the board of VirtualScopics asked Jim to assume the ...
(Date:8/21/2014)... 21, 2014  SI-BONE, Inc. ( San Jose, ... the use of the iFuse Implant System, ® ... of the sacroiliac (SI) joint, announced that Priority Health ... its Lumbar Fusion Medical Policy No. 91590-R4 providing positive ... policy states that the fusion procedure, which employs the ...
(Date:8/20/2014)... 2014  The National Association of Drug Diversion ... by the real-time, pseudoephedrine (PSE) blocking system in ... Exchange (NPLEx), automatically blocks unlawful PSE sales and ... and make arrests. Data released by NPLEx shows ... blocked the sale of more than 23,478 boxes of ...
Breaking Medicine Technology:VirtualScopics, Inc. Names James Groff Chief Financial Officer 2VirtualScopics, Inc. Names James Groff Chief Financial Officer 3VirtualScopics, Inc. Names James Groff Chief Financial Officer 4SI-BONE, Inc. Announces Positive Coverage Decision by Priority Health 2SI-BONE, Inc. Announces Positive Coverage Decision by Priority Health 3Kentucky's Stop-Sale System Achieves Significant Results In Battle Against Meth 2
... 2011 As the Joint Select Committee on Deficit Reduction ... the next ten years, the Pharmaceutical Care Management Association ... committee opportunities to leverage greater use of pharmacy benefit management ... costs over that same time period. "Everyone in ...
... Aug. 31, 2011 LifeVantage Corporation (OTCBB: ... supplement, announced today that Douglas C. Robinson, the Company,s ... the Company,s Chief Science Officer, will be presenting at ... be held on September 11-13, 2011, at the Waldorf ...
Cached Medicine Technology:PCMA Outlines $100 Billion in Prescription Drug Savings for Deficit Reduction Committee 2PCMA Outlines $100 Billion in Prescription Drug Savings for Deficit Reduction Committee 3LifeVantage to Present at Rodman & Renshaw Annual Global Investment Conference 2
(Date:8/21/2014)... neuropathy is important for the successful treatment of ... Hospital of Kunming Medical University, China, led by ... index for nerve conduction studies in the early ... diabetes mellitus. Nerve conduction studies revealed that distal ... was slower, and sensory nerve action potential and ...
(Date:8/21/2014)... at the University of Montreal, the regions of the ... we train our bodies, movements and, critically, they interact ... knew that sleep helped us the learn sequences of ... subcortical regions are important in information consolidation, especially information ... is measured after a period of sleep, the brain ...
(Date:8/21/2014)... Rebecca Tabbert, owner of Calimesa Fit Body ... enjoyed watching as more people turn away from the ... camp environment. It’s not only good for her business; ... ‘treadmill-dumbbells-elliptical’ routine just doesn’t work,” she says. “Numerous research ... and lifting those cute little dumbbells does very little ...
(Date:8/21/2014)... Chicago, IL (PRWEB) August 21, 2014 ... EB-5 Business & Investment Exploratory Delegation to southern China ... unique opportunity to explore the rapid growing cities of ... each delegate will have the rare opportunity to meet ... their project(s) during a short weeklong time frame. ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 Hunhu ... wellness solutions, announced today that it has entered into ... best practices, mobile technology and predictive analytics for recruiting, ... , According to Michael Emerson , co-founder ... for two patents on the technology used in what ...
Breaking Medicine News(10 mins):Health News:Learning to play the piano? Sleep on it! 2Health News:Calimesa Fit Body Boot Camp Announces Its Release of a New Video about the Fitness Boot Camp Experience 2Health News:Calimesa Fit Body Boot Camp Announces Its Release of a New Video about the Fitness Boot Camp Experience 3Health News:Artisan Business Group announces 2014 EB-5 Investment Trade Mission to China 2Health News:Hunhu Healthcare Enters into Licensing Agreement with Mayo Clinic 2
... to the Georgia Banker,s Insurance TrustATLANTA, March 3 ... of the Georgia Bankers Association Insurance Trust (GBAIT), ... Health, a health care data analytics company. ... cost and care management program that integrates wellness, ...
... Solos Endoscopy, Inc. (Pink Sheets: SNDY) is pleased ... and Drug Administration (FDA) Level II Baseline Inspection and ... It is standard for the FDA to periodically perform ... inspection by the FDA validates the Company,s quality system ...
... a malabsorption syndrome conferring increased risk for various ... is significantly more frequent in patients with newly ... research team led by Dr. Muhammed Hadithi from ... and vitamin B12 daily supplements on homocysteine levels ...
... safe handling, packaging and administration of fluid medications, today announced ... robotics and software company. The ForHealth acquisition adds IntelliFill ... operations management. , ... Englewood, Colo. ...
... PALM BEACH GARDENS, Fla., March 3 Believing ... crucial especially with today,s financial crisis deepening, SilverCensus.com ... for caregivers, senior citizens, and healthcare professionals, announced ... to provide educational support for viewers seeking eldercare ...
... GenCircles, and Family Tree Legends to help ... founder of numerous genealogy companies and products, Cliff Shaw, recently ... "FamilyLink is charting new territory in family social networking ... of this. The growth the company is experiencing, even in ...
Cached Medicine News:Health News:Paragon Benefits, Inc. Selects North Star Health for Data Analysis and Cost Management Reporting 2Health News:Solos Endoscopy, Inc. Successfully Completes FDA Inspection 2Health News:Are vitamin supplements effective in celiac disease patients? 2Health News:Baxa Corporation Acquires Florida-Based ForHealth Technologies™ 2Health News:Baxa Corporation Acquires Florida-Based ForHealth Technologies™ 3Health News:SilverCensus.com Names Consumer Affairs Advocate, Healthcare Experts to Provide Free Educational Support for Seniors 2Health News:FamilyLink.com, Inc. Announces New Lead Developer 2Health News:FamilyLink.com, Inc. Announces New Lead Developer 3
... The Portex® Thermovent® T helps provide protection ... It is small and extremely lightweight making it ... adults. With a high rate of heat and ... secretion retention., ,All HMEs and filters have ...
circuitGuard™ Products are available in filter or filter/HME styles., ,High quality air cushion anesthesia masks may be packaged with any circuitGuard™ product....
... Since 1991 Intersurgical Incorporated ... filters, heat and moisture ... therapy products, hand-held nebulizers ... of accessories and connectors ...
... 1991 Intersurgical Incorporated manufactures ... heat and moisture exchangers, ... products, hand-held nebulizers and ... accessories and connectors for ...
Medicine Products: