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

I am sitting in the hospital getting pumped full of poison and I just had my first meeting with my new oncologist-Swedens head of upper gi cancers. He has left me intrigued and a little hopefull.

I asked him what is the plan if gem/cis doesnt work for me. Cagey man hinted about a "new" treatment he just heard of a month ago. When I said something about cc not being a good responder to chemo, the little tease said something along the lines of that is what we used to think, chemo may be more effective than we have thought. I tried to find out more, but he was quite tight lipped about it saying something to the effect that it was early stages and the right protocol/doses are stilll being worked out.

Hmm, what could this be? Marion, have you heard of anything in the drug trials that is getting really good results?  Hans and I got the impression it could be with Erbitux...though that is just a feeling putting different parts of the conversation together. Perhaps it is a very small European study he was referring to. I am curious. I will try to go around him and talk to my old oncologist and see if they have talked about it and has any knowledge.

Anyway, thought I would share some hope.

Kris

Cancer is a word, not a sentence.

36 year old patient with buckets of hope

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

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

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

Sure enough I went back and checked the marshalledwardsinc.com website.. In August 2009 it says the FDA approved Triphendiol for BOTH pancreatic and CC trials but it is in orphan drug status. (?) So, I have another email into Alan Husband of Novogen to see what this means.


Any other pipeline drugs anyone is aware of?
Ashley

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

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

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

Something else I forgot to add. I mentioned that Xeloda did not work for me. I cant remember what he said, but how he said it made me feel like whatever this new thing is, is being used with xeloda.

Was there a larger cancer conference recently? I got the impression this was a discussion he had with another doctor.

Kris

Cancer is a word, not a sentence.

36 year old patient with buckets of hope

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

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

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

Here is the email reply I received on Oct 27, 2009

Dear Ashley,
You are correct that the FDA approval was to allow studies to proceed in both pancreatic cancer and cholangiocarcinoma, but 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.
Thank you for your inquiry.
Regards
Alan Husband

Re: 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

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

Kris....keep me posted.  I would like to know which chemo he is contemplating.
Hugs
Marion

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