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Fennec Pharmaceuticals Ord Shs T.FRX

Alternate Symbol(s):  FENC

Fennec Pharmaceuticals Inc. is a commercial-stage biopharmaceutical company focused on its product candidate PEDMARK. It sells its product through a field force, including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and its programs supporting patient access to PEDMARK. PEDMARK is a Food and Drug Administration approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is a therapeutic agent with a dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. It has established Fennec HEARS, a single source program designed to connect PEDMARK patients.


TSX:FRX - Post by User

Post by fairweather1on Apr 20, 2013 11:05am
170 Views
Post# 21288871

Remembering how eniluracil came to AHX...

Remembering how eniluracil came to AHX...

Nothing earth shattering here, but since it will likely be quiet on the news front here for a while, I thought I would mention something I recently remembered about why Adherex got interested in eniluracil way back when.  There may be a bit of relevance to the current trial, but at the very least, a point of interest to anyone who hasn't been following this story for long.

I won't go into the long history of eniluracil at Burroughs-Welcome, GSK etc...that is all available online.  The short history is that the early drug developers saw some early stage trials with success (efficacy and reduced HFS), but then failed in phase III trials, and basically gave up. 

The thing that caught AHX mgt's attention at that point was that the final trials not only failed to improve outcome over patients in a control group; they faired WORSE than if you had done nothing.  So they studied the results, and saw this systematic error that they thought was related to the ratio of EU:5fu, and so ahx purchased the rights to continue development of the drug...with various agreements with GSK in place.  The subsequent trials had mixed results, but from what I have gleaned, AHX's old management did not follow some of Dr Spectre's theories in their trials.

Current management IS following Dr Spectre's advice, and hopefully will be rewarded, but the point of this post pertains to the fact that, in the current trial, efficacy is similar in  arms 1 and 2, yet drastically different in arm X (ie:  eniluracil vastly better).  Once again, this suggests a systematic error.

For anyone doing statistical research, when you see systematic error in regression analysis (in other words, errors are not random, but show a bias in one direction), you take those into account and remodel until the difference is random, and only then do you have the line of best fit to reality.  Granted, it may be tricky to figure out the source of the discrepancy, but the more I think about it, arm X results suggest that, with adequate research and experimentation, arm 1 will eventually perform better than arm 2.

The only question to me, therefore, is how much time/money will it take to figure out?  With all the research money out there, I hope someone sees this hidden potential.

 

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