![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by halcyondaze on January 15, 2007, at 21:43:05
Targacept, Inc. (Nasdaq: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics(TM), today announced that it has initiated a Phase I clinical trial of TC-2216, its product candidate for the treatment of depression and anxiety disorders.
The trial is designed to evaluate the safety and tolerability of TC-2216 and to assess its pharmacokinetic profile. The trial is a double-blind, placebo-controlled crossover study, with sequential ascending single oral doses administered to healthy male volunteers.
TC-2216 is a novel compound discovered using Targacept's proprietary drug design platform known as Pentad(TM). The compound targets specific neuronal nicotinic receptors (NNRs), a class of receptors found in the central nervous system that play a critical role in regulating nervous system activity. TC- 2216 selectively inhibits the alpha4beta2 NNR to modulate the release of neurotransmitters that are involved in mood regulation. In preclinical studies, TC-2216 showed greater potency than and anti-depressant effects comparable to selective serotonin reuptake inhibitors and tricyclics, which are commonly used treatments for depression, as well as anxiety-relieving effects.
Targacept currently plans to develop TC-2216 as an oral monotherapy. In November, the company announced positive top line results from a Phase II clinical trial of TRIDMAC(TM), a treatment combination comprised of mecamylamine hydrochloride as an augmentation therapy to citalopram hydrobromide, in patients who did not respond adequately to citalopram alone. Mecamylamine hydrochloride binds non-selectively to various NNR subtypes, but there is a body of scientific evidence that suggests that its anti-depressant activity is derived through its antagonism at the alpha4beta2 NNR.
"Depression is a highly debilitating illness, and millions of people who suffer with it are not gaining adequate relief from existing therapies," said J. Donald deBethizy, Ph.D., Targacept's President and Chief Executive Officer. "The results of our TRIDMAC trial not only substantiate the promise of the NNR mechanism in the treatment of depression and other mood disorders, but also further bolster our enthusiasm for the potential of TC-2216."
Posted by Reggie BoStar on January 15, 2007, at 23:56:19
In reply to Phase I Clinical Trial Of TC-2216, novel AD, posted by halcyondaze on January 15, 2007, at 21:43:05
Do you have any additional information on references, such as web sites for the manufacturer and where that press release could be found?
I'm interested in finding out if this drug is as "involved" as the MAOI's, which cause all sorts of problems with drug-food and grug-drug interactions.
Thanks,
Reggie BoStar
Posted by Reggie BoStar on January 15, 2007, at 23:57:27
In reply to Re: Phase I Clinical Trial Of TC-2216, novel AD, posted by Reggie BoStar on January 15, 2007, at 23:56:19
Sorry, I meant to say "drug-drug", not "grug-drug".
(sigh)
Reggie BoStar
Posted by Reggie BoStar on January 16, 2007, at 0:00:18
In reply to Phase I Clinical Trial Of TC-2216, novel AD, posted by halcyondaze on January 15, 2007, at 21:43:05
Here's the press release at Targacept's web site:http://www.targacept.com/wt/page/pr_1168026763
Reggie BoStar
Posted by Phillipa on January 16, 2007, at 9:41:46
In reply to Never mind, found the link, here it is, posted by Reggie BoStar on January 16, 2007, at 0:00:18
How come only males? Love Phillipa
Posted by shadowplayers721 on January 16, 2007, at 19:40:05
In reply to Phase I Clinical Trial Of TC-2216, novel AD, posted by halcyondaze on January 15, 2007, at 21:43:05
A novel AD to me would be one that doesn't enlarge my gut and deaden my privates - all the while I am feeling pain relief, relaxed, and less depressed. Hmmm,maybe that's utopia. I think I was having a lucid dream. Pardon... zzzz
Posted by Jimmyboy on January 16, 2007, at 20:20:39
In reply to Re:, novel AD, posted by shadowplayers721 on January 16, 2007, at 19:40:05
Hell yeah, thats good news there, at least there are some unique ideas in the pipeline instead of Na and Serotonin..
Posted by Reggie BoStar on January 16, 2007, at 21:50:26
In reply to Re: Never mind, found the link, here it is, posted by Phillipa on January 16, 2007, at 9:41:46
Hi Phillipa,
Moley, I didn't even notice that.
Last time I looked at the stats, they said that woman suffering from depression outnumbered the men by 2/1, even when some kind of compensation was made for men who were reluctant to report it.
(Obviously I have no problem with that sort of reluctance. In fact, my paranoia tells me that my pdoc is conspiring with my oral surgeon to wire my mouth shut!)
Excluding women from a study like that would seem to be a pretty brain-dead thing to do, considering those stats.
Wonder what they have in mind?
I think I'll go to that site and see if I can find some reference to the gender preference in that study.
Thanks for pointing that out,
Reggie BoStar
Posted by halcyondaze on January 17, 2007, at 7:50:43
In reply to Re: Never mind, found the link, here it is » Phillipa, posted by Reggie BoStar on January 16, 2007, at 21:50:26
A lot of Phase I trials are done on men only. These are very short studies - not to determine efficacy, but to determine safety. Women are excluded because if the drug is NOT safe to take, then it could also cause birth defects if someone becomes pregnant.
Posted by Reggie BoStar on January 18, 2007, at 0:27:11
In reply to Re: Never mind, found the link, here it is, posted by halcyondaze on January 17, 2007, at 7:50:43
Hi halcyondaze,
I didn't think of the brith defects risk. It's a good thing they're not putting women at risk that way.
Shoot, I'm not thinking about a lot of things these days. I'd better go re-check those patient handouts for Testosterone and Lamictal.
Have a good one,
Reggie BoStar
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.