Navigation Links
Bionovo's Independent Data Safety Monitoring Board Recommends Continuation of Phase 3 Study for Menerba™
Date:3/28/2012

EMERYVILLE, Calif., March 28, 2012 /PRNewswire/ -- Bionovo, Inc. (OTCQB: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, announced today that the Company's independent Data Safety Monitoring Board (DSMB) recommended that the Phase 3 trial of Menerba (MF101) could continue as designed after an initial review of its clinical safety and tolerability data. Menerba is Bionovo's oral botanical drug candidate designed for the safe and effective treatment of vasomotor symptoms (hot flashes) associated with menopause.

The DSMB evaluated unblinded safety and dose tolerability data after 66 participants were randomized and on study medication for at least 30 days.  After an independent review of the data, the DSMB issued their positive recommendation to continue the trial as originally designed and no concerning safety signals were identified.

"I am very encouraged by the positive recommendation from our independent DSMB. This assurance that Menerba™ continues to be a safe, well-tolerated, non-estrogen alternative therapy for the treatment of menopausal hot flashes is consistent with the promising results of our early clinical trial data and extensive pre-clinical toxicity studies. We are very eager to continue to develop a safe and effective treatment for post-menopausal hot flashes, a drug that can be the leading seller in the well established multibillion dollar market," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.  

The MF101-004 Phase 3 pivotal study dosed its first patient on November 16, 2011. To date, a total of 280 postmenopausal women have been randomized to the trial. Recruitment to the Phase 3 trial was voluntarily halted on March 9, 2012 as Bionovo does not have adequate funding to further advance the registration trial. Bionovo will need to secure additional financing to complete either a
'/>"/>

SOURCE Bionovo, Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Halo Therapeutics Reports Favorable Independent Review of Lead Drug Candidate HT-100
2. New Survey: Walgreens Customers Flock to Independent Pharmacies
3. EPS Security to Add "Medical Alert" Services for Independent Seniors
4. Independent Data Published on BioLife Solutions HypoThermosol® and CryoStor®
5. Aria Announces Publication of Independent Study in the American Journal of Obstetrics & Gynecology Using Arias Technology
6. Parata Systems Announces Presenting Sponsorship of 2012 Independent Pharmacy Business Growth Conference
7. Winner Medical Appoints BDO China as Independent Auditor
8. NCPA Launches Initiative to Help Independent Community Pharmacies Create Better Business Opportunities for Front-End Merchandise
9. Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena® and Compounded 17P Formulations
10. Adeona Appoints Jeff Lucero Riley as Independent Chairman
11. NCPA Digest Finds Independent Community Pharmacies Reducing Health Costs Through Generic Drug Use, Patient Counseling
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... PARIS , May 17, 2013  Sanofi (EURONEXT: ... the pivotal study, JAKARTA , examining ... its primary endpoint in both dose groups. The primary ... of spleen volume. Consistent with data reported in previous ... nausea and vomiting. Full results will be presented at ...
(Date:5/16/2013)... ZURICH , May 17, 2013 ... Research (A*STAR) and Switzerland,s Cytos Biotechnology ... dosed in a Phase 1 clinical trial with their H1N1 ... particle (VLP) technology. In this first Phase 1 clinical trial, ... its potential to protect against H1N1 influenza infection will be ...
(Date:5/16/2013)... N.C. , May 16, 2013  Today, the ... North Carolina House of Representatives recently approved ... for chemotherapy from charging patients higher out-of-pocket fees for ... formularies, many of which have more severe side-effects. However, ... limit of $300, which will continue to be a ...
Breaking Medicine Technology:Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis 2Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis 3Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis 4Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis 5Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis 6A*STAR and Cytos Bring Singapore's First Influenza Vaccine to Clinical Testing 2A*STAR and Cytos Bring Singapore's First Influenza Vaccine to Clinical Testing 3A*STAR and Cytos Bring Singapore's First Influenza Vaccine to Clinical Testing 4A*STAR and Cytos Bring Singapore's First Influenza Vaccine to Clinical Testing 5A*STAR and Cytos Bring Singapore's First Influenza Vaccine to Clinical Testing 6National Patient Advocate Foundation Responds to N.C. State House Approval of Flawed Cancer Treatment Fairness Bill 2National Patient Advocate Foundation Responds to N.C. State House Approval of Flawed Cancer Treatment Fairness Bill 3
(Date:5/18/2013)... Wine World Accessories, a renowned online store ... attractive 25% discount on Franmara Dynamo Electric Wine ... purchase this electric corkscrew opener for $44.95 via Wine ... online store ensures delivery of their items within 1-2 ... , A spokesperson from the online store elaborates the ...
(Date:5/18/2013)... CA (PRWEB) May 18, 2013 ... latest update to consumers about transvaginal mesh ... federal court Resource4thePeople reports that plaintiffs have ... to court documents. , The rulings came ... District Court in the Southern District of ...
(Date:5/18/2013)... (PRWEB) May 18, 2013 Medical device company, ... for its much anticipated mobility aid with its namesake, the ... a hands-free crutch alternative that injured individuals can ... ankle, for example, can remain active and walk during a ... using its reservation system to ensure those who need the ...
(Date:5/18/2013)... 2013 Three new locations will be ... wellness centers and one therapeutic dispensary. Patient Appreciation Fair ... weekend of May 25th – May 27th, particularly honoring ... All events will take place from 11:00 ... Elements Therapeutic Dispensary , 10580 S. State Route 69, ...
(Date:5/17/2013)... inflict lasting damage to brain regions associated with fear ... stress disorder, or PTSD, have shown that these brain ... such as recalling a traumatic event or reacting to ... NYU School of Medicine have explored for the first ... with PTSD in the absence of external triggers. ...
Breaking Medicine News(10 mins):Health News:Now Save 25% on Franmara Dynamo Electric Wine Bottle Opener at Wine World Accessories 2Health News:2013 Alleged Transvaginal Mesh Complications Lawsuits Update: Resource4thePeople Reports Defendants Ordered to Provide Testimony, Documents 2Health News:2013 Alleged Transvaginal Mesh Complications Lawsuits Update: Resource4thePeople Reports Defendants Ordered to Provide Testimony, Documents 3Health News:2013 Alleged Transvaginal Mesh Complications Lawsuits Update: Resource4thePeople Reports Defendants Ordered to Provide Testimony, Documents 4Health News:FlexLeg Begins Offering New Mobility Aid 2Health News:Elements Honors Medical Marijuana Patients at Elements Health and Wellness Centers and Elements Therapeutic Dispensary 2Health News:Elements Honors Medical Marijuana Patients at Elements Health and Wellness Centers and Elements Therapeutic Dispensary 3Health News:Elements Honors Medical Marijuana Patients at Elements Health and Wellness Centers and Elements Therapeutic Dispensary 4Health News:For combat veterans suffering from post-traumatic stress disorder, 'fear circuitry' in the brain never rests 2
... of Facial Plastic Surgery, an innovative technique in African American rhinoplasty ... ... New York, NY (PRWEB) July 18, 2008 -- In a ... and Director of The Aesthetic Facial Surgery Institute of New ...
... intensive care can expect long-term quality of life at ... today in BioMed Central,s open access journal Critical ... allocation of resources to the treatment of heart attack ... other intensive care patient groups. , More than 600,000 ...
... for Healthcare Information Technology (CCHIT®) today announced that ... meets the Commission's ambulatory electronic health record (EHR) ... the CCHIT Certified seal, physicians and other providers ... product, allowing them to focus their evaluation on ...
... Universal,Health Services, Inc. (NYSE: UHS ) announced ... cash dividend of $0.08 per share on September 15,2008 ... Universal Health Services, Inc. is one of the ... and behavioral,health hospitals, and ambulatory centers nationwide and in ...
... reveal a lot about how they make decisions when feeling ... Associate Professor Uwe Dulleck, from the QUT Business Faculty, said ... it was, in fact, a natural reaction that had been ... the Australian arm of a study that was awarded an ...
... age 17 boosted odds for being heavy smoker , , THURSDAY, ... variations that affect their nicotine receptors seem to be at ... smoking before they turn 17, a new study says. ... young age are more likely to face severe nicotine dependence ...
Cached Medicine News:Health News:New Study Shows Facial Plastic Surgery Helps African American's Perserve Ethnicity 2Health News:New Study Shows Facial Plastic Surgery Helps African American's Perserve Ethnicity 3Health News:Heart attack not a death sentence 2Health News:gloEMR Version 4.0, gloStream's Flagship Electronic Medical Record Solution, Receives 2007 CCHIT Certification 2Health News:gloEMR Version 4.0, gloStream's Flagship Electronic Medical Record Solution, Receives 2007 CCHIT Certification 3Health News:Decisions under pressure: it's all in the heartbeat 2Health News:Gene Mutation Puts Some Kids at Risk for Tobacco Addiction 2
... The mobile universal operating table for ... top allows for unlimited C-arm access. ... for both neurosurgical and cardiovascular procedures. ... for floor support can easily be ...
... the Cmax operating table that combines all ... table with the radiolucence and precise mobility ... most advanced, versatile surgical table on the ... support advancements in surgical procedures and imaging ...
... Table offers complete imaging access, with nearly ... and mobile imaging C-Arms can pan from ... reposition the patient. Anesthesiologists will appreciate this ... drive, quality construction, and ease of operation. ...
...
Medicine Products: