Any one with a clue as to what can be in the pipeline?

Great Ashley….I will post mine also.
Dear Marion
Triphendiol was granted orphan drug status by the U.S. Food and Drug Administration for pancreatic cancer and cholangiocarcinoma in January 2008 and for treatment of stage IIb-IV malignant melanoma in February, 2008. In December 2008 the FDA granted an IND to enable a Phase Ib study of triphendiol in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic cancer and cholangiocarcinoma. Although we have obtained FDA approval to allow studies to proceed in both pancreatic cancer and cholangiocarcinoma, due to limited resources the Company has decided to only progress the pancreatic cancer studies at this time. We have not commenced any trials with triphendiol yet and we are still in the process of engaging a contract manufacturer to undertake scale-up manufacturing of the drug to enable sufficient quantities to undertake the planned studies. There is no indication at this stage of when the trial will commence, but it is likely to be either in Australia or in the USA and we have no plans to undertake trialling in Sweden or other parts of Europe at this time.
Sincerely
Alan Husband

Kris,
I wonder if it is another drug called Davanat. It helps to allow higher doses of 5-FU get to the tumor. Trials were done a few years ago so I’m not sure it is all that new. Or had it done wonders maybe we would have heard more about it??
Ashley

This is the e-mail I had received from Prof. Husband dated March 29, 2009.

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

Hi Kris,
The only potential I am aware of is triphendiol ( the Novegen website spoke of its use in bile duct cancer). I had emailed about triphendiol back in July 2009 and here was the response: ( the website sounded more hopeful)

Triphendiol is an investigational drug and it is not approved for sale or clinical use, except under controlled conditions of approved clinical trials. While we have announced that the FDA has approved a proposed trial of triphendiol in pancreatic cancer patients, we are not at this stage planning to explore its use in cholangiocarcinoma. There is still work to be done in manufacturing drug and designing study protocols before we can commence any studies. There are no other trials current with triphendiol in the treatment of cancer, but we are moving as rapidly as possible towards obtaining the approvals necessary for this clinical study in the US. I cannot predict when these trials may be able to commence as the timing for manufacturing and protocol approvals will be in the hands of regulatory authorities and it will likely be early 2010 before we are in a position to commence the first study. However we will be announcing our progress in due course and you should keep a watch on the Marshall Edwards, Inc. website for any news (http://www.marshalledwardsinc.com ).
Sincerely
Alan Husband

Prof Alan J Husband
Group Director of Research
Marshall Edwards, Inc.
140 Wicks Road, North Ryde, NSW, 2113
Australia