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

Tanespimycin is the First Hsp90 Inhibitor to Enter Registration Trials

HAYWARD, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that it has successfully reached a binding agreement with the U.S. Food and Drug Administration (FDA) on the design of its TIME-1 clinical trial, a pivotal Phase 3 trial of its Hsp90 inhibitor tanespimycin as a treatment for patients with multiple myeloma. Through the FDA's Special Protocol Assessment (SPA) process, Kosan and the FDA have reached agreement on overall protocol design, primary efficacy endpoints and data analysis as well as aspects of expected labeling if the data from the pivotal trial are supportive and tanespimycin is approved by the FDA. This pivotal Phase 3 protocol, as well as the overall development program, have also completed the "Scientific Advice" process with the centralized European Medicines Agency (EMEA).

Kosan's registration program for tanespimycin, called Tanespimycin in Myeloma Evaluation or TIME, has been initiated and includes two clinical trials: TIME-1 and TIME-2. TIME-1 is a pivotal Phase 3 trial to be conducted in a first-relapse patient population. TIME-1 will evaluate the clinical benefit of adding tanespimycin to bortezomib and compare these results to those seen with single-agent bortezomib. The Special Protocol Assessment Kosan has completed applies to the TIME-1 trial. TIME-2, which is designed to be supportive of the TIME-1 trial, is a Phase 2/3 trial in patients with relapsed-refractory disease. The TIME-2 trial also has the potential to support registration in the relapsed-refractory setting. Kosan has initiated the TIME-2 trial, which is enrolling patients, and expects to init
'/>"/>

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:8/29/2014)... -- Research and Markets has announced the ... of Pharmaceutical Equipment Market in China, 2014-2018" report ... Trend Forecast of Pharmaceutical Equipment Market in ... pharmaceutical equipment industry in the aspects of ... business performance of domestic major enterprises, as well as ...
(Date:8/29/2014)... , Aug. 29, 2014  Unilife Corporation ("Unilife" ... announced today that it intends to release its financial ... ended June 30, 2014 after market trading ends on ... scheduled a conference call for 4:30 p.m. U.S. EDT ... at 6:30 a.m. AEST), to review the Company,s financial results, ...
(Date:8/29/2014)... 2014  Pacific Medical Data Solutions is excited to ... . The main website, along with the site,s blog, ... services and content relevant to the medical billing industry. ... viewers can now better understand how PMDS products help ... create a more visible platform about medical billing best ...
Breaking Medicine Technology:Research and Development Trend Forecast of Pharmaceutical Equipment Market in China, 2014-2018 2Unilife Corporation to Announce Financial Results for Fiscal Year 2014 Fourth Quarter and Year End on Tuesday, September 9, 2014 2PMDS Announces New Website 2
... 2011 Mylan Inc. (Nasdaq: MYL ) ... Matrix Laboratories Limited) has received approval for three antiretroviral ... Health Organization,s (WHO) Prequalification of Medicines Programme. The products ... Tablet, 100 mg (heat-stable), and Tenofovir Disoproxil Fumarate and ...
... Medical imaging has revolutionized healthcare and is essential ... Modern equipment and protocols ensure that patients, physicians, and ... radiation, while still providing accurate results and diagnostic information. ... medical procedure must be balanced with the benefits of ...
Cached Medicine Technology:Mylan Receives WHO Approval for Innovative 'Second-Line-in-a-Box' HIV/AIDS Treatment 2Mylan Receives WHO Approval for Innovative 'Second-Line-in-a-Box' HIV/AIDS Treatment 3Mylan Receives WHO Approval for Innovative 'Second-Line-in-a-Box' HIV/AIDS Treatment 4AAPM Cautions that Patients Should Not Forgo Essential Medical Imaging 2
(Date:8/29/2014)... 29, 2014 Dr. Parsa Mohebi M.D. has ... hair loss achieve great results in hair transplantation. One ... Transplant , an FUE method that harvests facial hair for ... method lets patients whose hair loss classification is 5 and ... is a great alternative for those advanced hair loss patients ...
(Date:8/29/2014)... Highly regarded audiologist , Dr. Mary Ann Larkin has ... four reports are titled:, , Revealing the Truth ... , The Top 5 Things You Should Know Before ... in Children , Dr. Mary Anne Larkin choose to ... confusion and misinformation about each them. The reports are available ...
(Date:8/29/2014)... 2014 Pursuing its deepest desires to ... unveil a stunning new design that promises to redefine ... highly notable surrogacy platform has witnessed a 42 percent ... visitors a month, the FindSurrogateMother.com community is formed by ... common goal — the precious gift of life. , ...
(Date:8/29/2014)... 29, 2014 (HealthDay News) -- If you have bunions, taking ... treatment later, an expert says. A bunion is a ... when bone or tissue moves out of place and extends ... can cause debilitating pain and may require surgery to correct, ... Medical Center in Freehold, N.J. To prevent bunions, avoid ...
(Date:8/29/2014)... August 29, 2014 - Despite US Preventive Services ... are many barriers, several of which may be ameliorated ... researchers at NYU Langone Medical Center published online August ... Medicine ( JGIM ). , David Levine, MD, ... Internal Medicine at NYU Langone, and colleagues found that ...
Breaking Medicine News(10 mins):Health News:Advanced Hair Loss Patients Can Now Qualify for Hair Transplants Using Facial Donor Hair 2Health News:Charleston SC Audiologist, Dr. Mary Ann Larkin Authors Four New Special Reports on Important Hearing Healthcare Topics 2Health News:Charleston SC Audiologist, Dr. Mary Ann Larkin Authors Four New Special Reports on Important Hearing Healthcare Topics 3Health News:FindSurrogateMother.com Set to Unveil Stunning New Design as Member Sign-ups Increase by 42% since January 2Health News:FindSurrogateMother.com Set to Unveil Stunning New Design as Member Sign-ups Increase by 42% since January 3Health News:Take Steps to Control Bunions 2Health News:Options for weight loss your primary care doctor might not know about 2
... Than 1,500 YMCAs Get Their Communities Moving During Week-Long Event; ... YMCAs Aim to Keep Communities Active Year-Round, WASHINGTON, ... logged during "America On the Move Week with the YMCA" ... More than 1,500 YMCAs nationwide reached out to their ...
... With an eye on curing diabetes, scientists at Washington ... transplanted embryonic pig pancreatic cells destined to produce insulin ... for risky immune suppression drugs that prevent rejection. , ... earliest stages of developing into pancreatic tissues. Within several ...
... it instead of traditional immune globulin injection , , THURSDAY, ... hepatitis A with the hepatitis A vaccine is as ... of immune globulin, a new study found. , Based ... and Prevention,s Advisory Committee on Immunization Practices now recommends ...
... Union Urges Congress to Enact HR 1174 (Murphy) ... WASHINGTON, Oct. 18 A new study that,estimates ... virulent,antibiotic-resistant infection acquired mostly in the hospital underscores,the ... patient infection,rates, according to Consumers Union, the nonprofit ...
... device evaluated in cadaver by leading spine ... ... CoreSpine Technologies LLC, an,emerging spinal device company located in Minneapolis, Minnesota ... first product in development is a complete nucleus removal,device that seeks ...
... Conseco, Inc. (NYSE:,CNO) will report results for the ... 31, 2007. The company will host a conference call ... November 1, 2007. The web cast of the ... the company,s website as follows:, http://investor.conseco.com . Listeners should ...
Cached Medicine News:Health News:YMCA's Activate America(R) Motivates More Than 1.3 Million People to Take 8 Billion Steps Toward a Healthier Lifestyle During 'America On the Move Week with the YMCA' 2Health News:YMCA's Activate America(R) Motivates More Than 1.3 Million People to Take 8 Billion Steps Toward a Healthier Lifestyle During 'America On the Move Week with the YMCA' 3Health News:YMCA's Activate America(R) Motivates More Than 1.3 Million People to Take 8 Billion Steps Toward a Healthier Lifestyle During 'America On the Move Week with the YMCA' 4Health News:Cross-species transplant in rhesus macaques is step toward diabetes cure for humans 2Health News:Cross-species transplant in rhesus macaques is step toward diabetes cure for humans 3Health News:Hepatitis A Vaccine Best Bet to Treat Virus 2Health News:Hepatitis A Vaccine Best Bet to Treat Virus 3Health News:Alarming MRSA Infection Rates Underscore Need for Public Reporting of Hospital-Acquired Infections 2Health News:Alarming MRSA Infection Rates Underscore Need for Public Reporting of Hospital-Acquired Infections 3Health News:Initial Evaluation of New Nucleus Removal Device Provides Promising Results 2
... standard trial frames. They are made of optical quality ... box. There are two sets available providing a full ... is that a patient can wear the prism with ... the patient to adapt to the use of the ...
... C Dermatome - reaching a new evolutionary plateau. ... to operate in the pulse mode, or to ... entire instrument and hose assembly is autoclavable and ... 2-, 3-, or 4-inch widths. Simply select the ...
A finely parallel striated (scratched) clear plastic membrane encapsulated between glass plates....
BD Visitec IOL Manipulator (Fenzl), blunt tip angled 45, 12.0 mm from end, fits 0.20 mm diameter holes and larger (3/bx, 1 bx/ca). For positioning intraocular lenses. Sure grip handles hand ridge ind...
Medicine Products: