Navigation Links
Bioniche Receives Fast Track Designation For First-Line Bladder Cancer Therapy
Date:3/4/2008

t program with Urocidin," said Graeme McRae, President & CEO of Bioniche Life Sciences Inc. "It highlights the need for a safer and more effective therapy for first-line bladder cancer patients. The FDA clearly recognizes that the current approved therapy is less than satisfactory, and wishes to expedite the introduction of new therapies."

In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure for this Phase III trial of Urocidin as a first-line therapy. An SPA provides assurance that, if the proposed endpoints are met, they will serve as the basis for approval of the product as part of a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of the product when the study endpoints are achieved.

Bioniche plans to begin recruitment of patients for this second pivotal study later this year. The study currently plans to enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.

The Company also continues to enroll patients in its first Fast Track Phase III clinical trial with Urocidin. When fully enrolled, this trial will involve 105 patients in North America with non muscle-invasive bladder cancer that is refractory to BCG. The Company reported last month that the Data Safety Monitoring Committee held its third scheduled quarterly meeting regarding this clinical trial, after which it recommended that Bioniche "continue the trial unmodified until the next scheduled or triggered meeting." The next meeting of the Committee will be held in May, 2008.

About MCC


'/>"/>
SOURCE Bioniche Life Sciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Bioniche Pharma Chooses TrackWise for its Deviation Control Solution
2. Bioniche Provides Update on Refractory Bladder Cancer Trial with Urocidin(TM)
3. Bioniche Reports Fiscal 2008 Second Quarter
4. USDA Agrees to Grant Conditional License to Bioniche for its E. coli O157:H7 Cattle Vaccine
5. Bioniche Amends Terms of Convertible Debt with Laurus Master Funds
6. Bioniche Receives $5 Million of Federal Government Support to Scale-up Vaccine Production in Ontario
7. Bioniche Reports Fiscal 2008 First Quarter
8. Bioniche to Present at Rodman & Renshaw 9th Annual Healthcare Conference
9. Media Advisory - Bioniche Discusses USDA Comment on E. coli O157:H7 Cattle Vaccine Field Trial
10. Bioniche Receives Comment from USDA on a Field Trial for E. coli O157:H7 Cattle Vaccine
11. Bioniche Food Safety Vaccine Receives Global Top Honours in Industry Excellence Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2015)... ... September 01, 2015 , ... Splashtop Inc. , ... Remote Support , a solution optimized for MSPs and IT professionals looking for ... prices and inadequate customer services of existing remote support solution, many MSPs and ...
(Date:9/1/2015)... ... September 01, 2015 , ... Virginia entrepreneur Marcella ... still strongly maintaining her firm’s success in the hair care and distribution industry ... city-to-city tour, Ellis will be providing “Look and learn” live demonstrations, as well ...
(Date:9/1/2015)... ... September 01, 2015 , ... OncLive® today ... U.S. News & World Report, to provide breaking news and information about the ... groups within OncLive, which provides oncologists resources and information?they need to deliver the ...
(Date:9/1/2015)... (PRWEB) , ... September 01, 2015 , ... The Jerry ... at The ACE Club and Green Valley Country Club in Lafayette Hill, PA. Over ... raised more than $13.5 million for programs and services designed to support patients and ...
(Date:9/1/2015)... ... ... With former IBMers among its founding members, Inmar has known the value of ... ago. A pilot program begun by the company in 2014 has proved popular with ... pursuing careers in these fields. The program is now open to area middle and ...
Breaking Medicine News(10 mins):Health News:Splashtop Launches Splashtop Business for Remote Support, the Simple, Reliable, and Cost-Effective Solution for MSPs and IT Professionals 2Health News:Splashtop Launches Splashtop Business for Remote Support, the Simple, Reliable, and Cost-Effective Solution for MSPs and IT Professionals 3Health News:Splashtop Launches Splashtop Business for Remote Support, the Simple, Reliable, and Cost-Effective Solution for MSPs and IT Professionals 4Health News:Beauty Entrepreneur creates hair extension smart machine and mobile app inspired by UBER technology 2Health News:OncLive® and Cleveland Clinic Team up to Provide News, Information About Cancer Research and Patient Care 2Health News:OncLive® and Cleveland Clinic Team up to Provide News, Information About Cancer Research and Patient Care 3Health News:The 26th Jerry Segal Classic Returns to Benefit Patients of Magee Rehabilitation Hospital 2Health News:The 26th Jerry Segal Classic Returns to Benefit Patients of Magee Rehabilitation Hospital 3Health News:Inmar Announces Program to Fuel Student Passion for STEM – with an Unconventional Twist 2
... Governor Edward G.,Rendell today released the text of his ... deadline for MCare fund assessment payments:, Dear Health ... that the state was in a unique,position to extend ... to affordable health care for hundreds of thousands of ...
... continue the habit after initial coil treatment surgery , , FRIDAY, ... who are treated with coil embolization are more likely than ... study. , If a brain aneurysm bursts, the bleeding ... is inserted into an artery in the groin and then ...
... View Special Video and Feedback on Web Site -, ... keeping kids,immunized, TriWest Healthcare Alliance,s network doctors provide America,s,Service ... during the,good times, and reassurance and support during challenging ... Day on Sunday, March 30,TriWest joins its TRICARE beneficiaries ...
... when their pre-schoolers talk to themselves; in fact, they ... of psychology at George Mason University. His recent study ... do better on motor tasks when they talk to ... do so by an adult) than when they are ...
... (Boston, MA)Researchers from Boston University School of Medicine ... nationwide have found that decreased sexual satisfaction in ... disease. This study appears in the April 2008 ... Female sexual dysfunction is a common condition and ...
... Meeting on Disparities in Cancer Care and Survival, ... the nation,s poor and ethnic minorities will be addressed ... Medicine hold the,11th Biennial Symposium on Minorities, The Medically ... in Washington, DC., The ICC Biennial Symposium is ...
Cached Medicine News:Health News:Governor Rendell Writes to Physicians to Explain MCare Fund Assessment Deadline 2Health News:Smokers at Increased Risk of Aneurysm Recurrence 2Health News:TriWest Recognizes Contributions of TRICARE Docs to Military Community on Doctors' Day 2Health News:Preschool kids do better when they talk to themselves, research shows 2Health News:Decreased sexual satisfaction is not associated with cardiovascular disease in postmenopausal women 2Health News:State of Cancer Care for Nation's Poor and Minorities Is Focus of Conference in Washington 2Health News:State of Cancer Care for Nation's Poor and Minorities Is Focus of Conference in Washington 3
(Date:9/1/2015)... BAKERSFIELD, Calif. , Sept. 1, 2015 /PRNewswire/ ... Chronic Care Management (CCM) and Drug Adherence m ... monitoring help automate the process of non face-to-face ... "With this new release of our apps, ... care management services along with our ONCHIT certified ...
(Date:9/1/2015)... , Sept. 1, 2015 Agena Bioscience TM ... Shanghai , a commercial and financial hub from which ... of genomic testing laboratories in mainland China ... of Agena Bioscience,s global sales with almost sixty MassARRAY ® ... China will allow us to expand our reach ...
(Date:9/1/2015)... 1, 2015 CytRx Corporation (NASDAQ: ... specializing in oncology, today announced that Steven ... and David Haen , Vice President of ... corporate overview at two significant investment conferences in ... industries: the FBR & Co. Second Annual Health ...
Breaking Medicine Technology:SPAC International's Drug Adherence and Chronic Care Management App Now available at Apple App and Google Play stores 2Agena Bioscience Opens Office in Shanghai, China 2CytRx Announces Participation at FBR & Co. Second Annual Health Conference and Rodman & Renshaw 17th Annual Global Investment Conference 2CytRx Announces Participation at FBR & Co. Second Annual Health Conference and Rodman & Renshaw 17th Annual Global Investment Conference 3CytRx Announces Participation at FBR & Co. Second Annual Health Conference and Rodman & Renshaw 17th Annual Global Investment Conference 4
... Corporation , a leading provider of medical devices and ... ExactaMix 1200 Automated Compounding Device (ACD) for small- ... approach to compounding large-volume parenteral doses.  The entry-level 12-port ... brings delivery precision and safe handling to pharmacies that ...
... BioMarin Pharmaceutical Inc. (Nasdaq: BMRN ) ... Senior Subordinated Notes due 2013 have agreed to exchange ... for approximately 5.25 million shares of the Company,s common ... outstanding principal amount.   "This partial exchange ...
Cached Medicine Technology:Baxa Corporation Introduces ExactaMix™ 1200 Automated Compounder for Sterile, Multi-Ingredient Solutions 2Baxa Corporation Introduces ExactaMix™ 1200 Automated Compounder for Sterile, Multi-Ingredient Solutions 3Baxa Corporation Introduces ExactaMix™ 1200 Automated Compounder for Sterile, Multi-Ingredient Solutions 4BioMarin Completes Partial Exchange of Convertible Notes Due 2013 for Common Stock 2BioMarin Completes Partial Exchange of Convertible Notes Due 2013 for Common Stock 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: