Topic: FDA Approval of investigation drug triphendiol

Came across this and thought some might be interested

Jan 08, 2009 (M2 EQUITYBITES via COMTEX) -- MSHL | Quote | Chart | News | PowerRating -- Marshall Edwards Inc (NasdaqGM:MSHL), a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics, said on 7 January that the company has received Investigative New Drug (IND) approval from the United States Food and Drug Administration (FDA) to undertake clinical studies with triphendiol as a chemosensitising agent in combination with gemcitabine.

The company stated that the approval will allow a Phase Ib study of triphendiol in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic and bile duct cancers. A Triphendiol (NV-196) is an investigational drug, currently being developed as an orally-delivered chemosensitising agent, intended for use in conjunction with standard chemotoxic anti-cancer drugs for the treatment of late stage pancreatic cancer, cholangiocarcinoma and melanoma.

2 (edited by marions Sat, 10 Jan 2009 13:06:42)

Re: FDA Approval of investigation drug triphendiol

After contacting the Group Director of Research (Prof. J. Husband) of  Marshall Edwards Inc. (an Australian company) in re: to the beginning date of this clinical trial,  I have been informed that a start date for the trial approved under this IND has not been set.  The Principal Investigator is: 

Dr. Wasif Saif
Yale University School of Medicine
Section of Medical Oncology
333 Cedar Street, FMP 116
New Haven, CT  06520
United States of America
Bus: +1 (203) 737-1569
Bus Fax: +1 (203) 737-2617

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: FDA Approval of investigation drug triphendiol

I had contacted the principal investigator in re: to the Phase II study conducted with this drug.  Previously, Cholangiocarcinoma had been targeted however, the current Phase II clinical trial only mentioned Pancreatic Cancer. 
I received an immediate response to my question:


You are correct that some time back we did announce that Triphendiol might potentially benefit Cholangiocarcinoma patients.  Its potential to be used in this indication is undiminished and we are confident that it could be equally effective in cholangiocarcinoma as it seems to be in pancreatic cancer and we continue to pursue this indication in pre-clinical studies.  However to simplify the clinical development program towards registration we have decided to target pancreatic cancer in our Phase II trials.  Should we achieve registration for this indication the drug could be used

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER