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:7/29/2014)... Mass., July 29, 2014 Cynosure, Inc. ... markets laser- and light-based aesthetic treatment systems for high-volume ... ended June 30, 2014. Second-quarter 2014 financial results incorporate ... on June 24, 2013. Second-Quarter ... increased 45% to $72.6 million , Non-GAAP net ...
(Date:7/29/2014)... July 29, 2014   ... will present data from a Phase I clinical ... slow or stop Parkinson,s disease progression. The Michael J. ... grant and will discuss the impact of the results ... When:   Thursday, July 31, 2014     ...
(Date:7/29/2014)... Calif. , July 29, 2014  Drug ... amplified with rising incidence rates and the intense ... a preventative vaccine. Change is underway as the ... regimens towards highly effective, easily-tolerated, interferon-free oral therapies. ... Gilead,s mega blockbuster Sovaldi is ...
Breaking Medicine Technology:Cynosure Reports Second-Quarter 2014 Financial Results 2Cynosure Reports Second-Quarter 2014 Financial Results 3Cynosure Reports Second-Quarter 2014 Financial Results 4Cynosure Reports Second-Quarter 2014 Financial Results 5Cynosure Reports Second-Quarter 2014 Financial Results 6Cynosure Reports Second-Quarter 2014 Financial Results 7Cynosure Reports Second-Quarter 2014 Financial Results 8Cynosure Reports Second-Quarter 2014 Financial Results 9Cynosure Reports Second-Quarter 2014 Financial Results 10Cynosure Reports Second-Quarter 2014 Financial Results 11Cynosure Reports Second-Quarter 2014 Financial Results 12Reminder/Media Advisory/AFFiRiS AG Presents Early Clinical Data on a First-of-its-Kind Parkinson's Disease Vaccine 2A Treatment Revolution is Underway: All-Oral Therapies Transform Global Hepatitis C Antiviral Market 2A Treatment Revolution is Underway: All-Oral Therapies Transform Global Hepatitis C Antiviral Market 3A Treatment Revolution is Underway: All-Oral Therapies Transform Global Hepatitis C Antiviral Market 4
... September 24 , - Novel Treatment ... and Reduction in Depressive Symptoms, Positive ... today at the 8th,European Congress of Epileptology, ... a novel once daily,anti-epileptic agent, significantly reduced ...
... Oral Insulin Capsule, ... on Type 1 Diabetics, JERUSALEM, Israel, September ... delivery systems, announced today that it has commenced Phase 2A,studies of ORMD ... Medical Center in Jerusalem, Israel., Oramed,s Phase 2A trial is focused ...
Cached Medicine Technology:New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy 2New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy 3New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy 4New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy 5New Data Show Efficacy of Zebinix(TM) in the Treatment of Epilepsy 6Oramed Pharmaceuticals Commences Phase 2A Trials of its Oral Insulin Capsule on Type 1 Diabetics 2
(Date:7/29/2014)... Society of America (GSA) the nation,s largest ... has chosen Barbara J. Bowers, PhD, RN, FAAN, of ... the Task Force on Minority Issues in Gerontology Outstanding ... to an individual who has exemplified outstanding commitment and ... aging. , The award presentation will take place at ...
(Date:7/29/2014)... likely to drink alcohol brands that advertise on television ... new and compelling evidence of a strong association between ... This is the conclusion of a new study from ... the Johns Hopkins Bloomberg School of Public Health and ... whether exposure to brand-specific alcohol advertising on 20 television ...
(Date:7/29/2014)... the nation,s largest interdisciplinary organization devoted to ... Lckenhoff, PhD, of Cornell University as the 2014 recipient ... Award in Behavioral and Social Gerontology. , This distinguished ... behavioral and social gerontology. Individuals who have received their ... award is given by GSA in conjunction with the ...
(Date:7/29/2014)... Nation Homelands, NY (PRWEB) July 29, 2014 ... Indian Nation have sent a letter to Washington NFL team ... representatives that opposition to the R-word racial slur is emanating ... date, the team and Snyder have yet to respond. ... release the full text of the letter, which was first ...
(Date:7/29/2014)... The report “Filling Equipment Market by Industry (Food, ... Weight), Process (Manual, Semi-Automatic, Automatic), Product (Solid, Semi-Solid, ... to 2019”, defines the filling equipment market and ... segments with analyses and projections of the market ... of value. It also identifies the driving and ...
Breaking Medicine News(10 mins):Health News:Bowers to receive GSA's 2014 Minority Mentorship Award 2Health News:Brand-specific television alcohol ads predict brand consumption among underage youth 2Health News:Löckenhoff earns GSA's 2014 Baltes Foundation Award 2Health News:Native American Groups Urge Washington Team Owner Dan Snyder to Stop Claiming Name Change Issue Driven by "Elites" Who Are Not People of Color 2Health News:Filling Equipment Market worth $8 Billion by 2019 - Report by MarketsandMarkets 2Health News:Filling Equipment Market worth $8 Billion by 2019 - Report by MarketsandMarkets 3Health News:Filling Equipment Market worth $8 Billion by 2019 - Report by MarketsandMarkets 4
... in UK it has been revealed that a increase in ... way we eat over the years.,The Mental Health Foundation and ... // have led to an increase in cases of depression, ... of the most important findings of the report was a ...
... Battle against Cancer, Singer, Actress and Diva Kylie Minogue has ... ,In a statement issued this week the Singer said ... // however her treatments were still ,continuing. ,It ... in the care ,of her family and friends after her ...
... Health Inc. told the National Heritage Insurance Co., the contractor ... accepted to cover its test. ,After this the ... $2.46 to $12.41 on Nasdaq. The company prepares oncotype DX ... is taking all the responsibility to cover the medical expenses ...
... applied for a financial grant amounting to approximately 110// ... for combating tuberculosis, said the Cabinet Minister. // ... Fund on AIDS, TB and Malaria, according to the ... approximately 15 and 30 million dollars would be approved ...
... scientific and research talent in frontier areas of research ... the preferred hub for knowledge-based industries. // ... to information and communication technology alone, but spans agriculture, ... space. ,India's efforts to become a superpower ...
... of the HIV drugs in the city of Vancouver in British ... 125 as a last hope to save their lives. // Though ... study is tested on a hope to find a cure and ... ,TMC 125 is Non-nucleoside reverse transcriptase inhibitor, which has found ...
Cached Medicine News:Health News:India set to become the global knowledge hub 2Health News:India set to become the global knowledge hub 3Health News:India set to become the global knowledge hub 4
... German Craftsmanship have produced ... in the world. Ocutek ... to you! Only holders ... certificate, which requires and ...
... German Craftsmanship have produced ... in the world. Ocutek ... to you! Only holders ... certificate, which requires and ...
... are constructed of a patented ... polyvinyl acetal sponge. Each device ... to both surgeon and patient, ... firm enough to gently manipulate ...
... Merocel Ophthalmic Products provide ... fiber free products for ... safe cleaning of fine ... Merocel material is highly ...
Medicine Products: