Navigation Links
Bionovo Releases FDA-Approved Clinical Development Plan for Menerba
Date:12/13/2010

EMERYVILLE, Calif., Dec. 13, 2010 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI), a pharmaceutical company focused on the discovery and development of innovative treatments for women's health and cancer, today announced that it had received the minutes from the U.S. Food and Drug Administration's (FDA) Clinical Guidance meeting that took place on November 8, 2010. In that meeting, the FDA agreed with the Company's proposed overall clinical development plan.

"We had a very positive meeting with the FDA to discuss the clinical program for Menerba. The Agency agreed with our overall clinical and non- clinical development plan for approval. The Agency did suggest a change to the clinical development plan which will allow for faster and more efficient initiation of the pivotal testing, by introducing a small Phase 1 study before the first Phase 3 study, which includes a dose 3 times higher than previously tested in the Phase 2," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.

"In order to reach higher efficacy we are evaluating the higher dose of Menerba in the first Phase 3 trial. The FDA would like to see additional safety data to assess this dose. We had originally proposed to the FDA to use the first 60 patients enrolled in our first Phase 3 study as subjects for safety evaluation. The protocol would have required enrollment to be suspended after 60 patients had been enrolled. Enrollment to study would continue only once an independent data and safety monitoring board (DSMB) had reviewed the safety data and deemed there were no safety issues," continued Dr. Tagliaferri.

"However, the Agency instead recommended, and we agreed to conduct, a Phase 1 study in advance of the Phase 3 study. The Phase 1 open label trial will enroll 20 postmenopausal women who will all receive Menerba 15g/day (7.5g BID) for 28 days. This approach wil
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Bionovo Announces Positive Developments in On-going Phase 1/2 Cancer Drug Trial
2. Bionovo Announces Publication of the Paper Detailing the Mechanism of Action of Its Cancer Drug BZL101
3. Bionovo Discovers New Estrogen Regulatory Elements for Breast Cancer and Osteoporosis Drugs
4. Bionovos Drug Candidate for Menopausal Symptoms Shows Effect on Neural Pathways Related to Temperature Regulation
5. Bionovo Elucidates Mechanism of Breast Cancer Control by Estrogen Receptor Beta
6. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
7. Bionovos MF101 Shows Statistically Significant Improvement in Sleep Disturbance from Hot Flashes
8. Bionovos VG101 Shows Greater Efficacy Than Estrogen in the Treatment of Vaginal Dryness
9. Bionovo Advances BZL101 to Phase 2 Clinical Trials After Positive Phase 1 Results for Metastatic Breast Cancer
10. Bionovo Presents Positive Results from Phase 1B Trial of BZL101 for Metastatic Breast Cancer at the Society for Integrative Oncology
11. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... , Aug. 27, 2014 Reportlinker.com announces that ... catalogue: Baby Food Eastern Europe 2014 ... Food Eastern Europe 2014" is a new report by ... in Eastern Europe , key segments, ... This report also examines trends which are currently affecting ...
(Date:8/27/2014)... 2014 An experimental drug designed to help regulate ... treatment for anemia of inflammation, according to results from the ... today in Blood , the Journal of ... Anemia is a condition that occurs when red blood ... When an individual has anemia, the body does not get ...
(Date:8/27/2014)... , Aug. 27, 2014 North American lighting ... prestigious R&D 100 Award for the new OSRAM ITOS ® ... LED-based white light module for microscopy, endoscopy and surgical head ... with significantly higher efficacy and lamp life. "We,re ... one of the most innovative new technologies of the past ...
Breaking Medicine Technology:Baby Food Eastern Europe 2014 2Baby Food Eastern Europe 2014 3Baby Food Eastern Europe 2014 4Baby Food Eastern Europe 2014 5Baby Food Eastern Europe 2014 6Baby Food Eastern Europe 2014 7Baby Food Eastern Europe 2014 8Drug Represents First Potential Treatment for Common Anemia 2Drug Represents First Potential Treatment for Common Anemia 3OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 2OSRAM ITOS PHASER 3000 Laser and LED Light Module Recognized With Prestigious R&D 100 Award 3
... 10, 2011 Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ... Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2011 ... being held at Westin St. Francis Hotel in San Francisco. ... will provide an overview of Anadys and its clinical development ...
... Mich., Jan. 10, 2011 Nopras Technologies, ... which specializes in services for organizations in the ... industries announced on January 10th, 2011 that it ... Nopras Technologies, well documented procedures and processes, ...
Cached Medicine Technology:Anadys Pharmaceuticals to Present at the J.P. Morgan Healthcare Conference 2Nopras Technologies, Inc. Achieves ISO 9001:2008 Certification 2
(Date:8/27/2014)... August 27, 2014 Dr. Stewart ... Center see multitudes of patients suffering from impaired vision. ... Cataract vision correction surgery . Recently, Dr. Shofner ... information during an eye exam and also online. To ... top five myths about glaucoma. , 1)    Myth: People with ...
(Date:8/27/2014)... August 27, 2014 The federal judge ... ) has extended the deadline for plaintiffs to enroll ... 2014 Order issued by U.S. District Judge David Katz ... enroll in the DePuy ASR Settlement Program must do ... Inc. ASR Hip Implant Products Liability Litigation – MDL ...
(Date:8/27/2014)... The extensive polling of 970 ... research group Black Book Rankings uncovers several alarming ... supplied or built to care for even a ... annual survey to gain stakeholder insight into the ... and emergency preparedness systems,” said Doug Brown, Managing ...
(Date:8/27/2014)... 2014 Ticket Down is a dependable source ... Life Stadium in Miami. The Brazilian national soccer team ... 5 at Sun Life Stadium in Miami Gardens, Florida. ... of the World Cup earlier this year when Brazil got ... The Brazilian Soccer Federation announced earlier this week that Neymar ...
(Date:8/27/2014)... -- There,s been controversy for years over whether the ... might raise the odds of mental health issues in ... 13,000 children finds no rise in the risk of ... while pregnant, but some data suggesting a heightened risk ... findings challenge prior research pointing to a link between ...
Breaking Medicine News(10 mins):Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 2Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 4Health News:DePuy ASR Settlement Enrollment Deadline Extended Until September 30, 2014, Bernstein Liebhard LLP Reports 2Health News:DePuy ASR Settlement Enrollment Deadline Extended Until September 30, 2014, Bernstein Liebhard LLP Reports 3Health News:American Hospitals Are Vastly Unprepared for Ebola Patients, Reveals Black Book™ Survey of Emergency Physicians, Nurses and Infection Control Practitioners 2Health News:American Hospitals Are Vastly Unprepared for Ebola Patients, Reveals Black Book™ Survey of Emergency Physicians, Nurses and Infection Control Practitioners 3Health News:American Hospitals Are Vastly Unprepared for Ebola Patients, Reveals Black Book™ Survey of Emergency Physicians, Nurses and Infection Control Practitioners 4Health News:Brazil vs. Colombia Tickets in Miami, FL: Ticket Down Cuts Ticket Prices on World Cup Rematch of Colombia vs. Brazil at Sun Life Stadium in Miami on Sept. 5th 2Health News:Brazil vs. Colombia Tickets in Miami, FL: Ticket Down Cuts Ticket Prices on World Cup Rematch of Colombia vs. Brazil at Sun Life Stadium in Miami on Sept. 5th 3Health News:Do Antidepressants in Pregnancy Raise Risks for Mental Woes in Kids? 2Health News:Do Antidepressants in Pregnancy Raise Risks for Mental Woes in Kids? 3
... 28 (HealthDay News) -- Increasing one,s physical activity routine ... patients, Swedish researchers report. Vigorous activity can also ... the researchers said. The authors noted that IBS ... 15 percent of people around the world, and is ...
... help preserve the voice and vocal cord function for ... to a study from Henry Ford Hospital in Detroit. ... laryngeal squamous cell carcinomas, offering patients a less invasive ... preserving the voice," says study co-author Vanessa G. Schweitzer, ...
... News) -- People who have suffered a frontal brain ... and new research shows that people diagnosed as psychopathic ... suggests that psychopaths may benefit from therapy similar to ... the researchers at the University of Haifa in Israel. ...
... , FRIDAY, Jan. 28 (HealthDay News) -- A new ... work better in people with high levels of a certain protein ... Researchers found that the drugs work the same -- at ... diabetics -- regardless of the results of a test that looks ...
... of Naval Research,s (ONR) TechSolutions department is set to ... year new protective eyewear that will eliminate the need ... to accommodate differences in light levels. The Fast-Tint ... commonly found at an optometrist,s office. "Transition time is ...
... Dennis Thompson HealthDay Reporter , FRIDAY, Jan. 28 (HealthDay ... hospice doesn,t mean you die on anyone else,s timetable. Dennis, ... years ago, after she was diagnosed with a fatal heart condition. ... live. "The illness, the heart condition that I have, is ...
Cached Medicine News:Health News:Exercise Helps Ease Irritable Bowel Symptoms 2Health News:Voice-saver: Light therapy for early-stage laryngeal cancer 2Health News:Voice-saver: Light therapy for early-stage laryngeal cancer 3Health News:Blood Protein Level May Not Influence Effectiveness of Statins 2Health News:ONR's TechSolutions providing SEALs with new glasses that change lens color on the fly 2Health News:Woman's Life Refutes a Hospice Myth 2
Modified Freer periosteal elevator, #163, slight curve, 21 cm....
Williger periosteal elevator, 6 1/4", sharp, 5 mm wide....
Alley periosteal elevator, extra long, 21 cm, 8-1/4"....
Periosteal elevator #9H, 17.5 cm, 7"....
Medicine Products: