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Re: seek the light post# 22713

Sunday, 04/19/2015 6:58:53 PM

Sunday, April 19, 2015 6:58:53 PM

Post# of 30990
As I recall, when the Euro trial direction was first publicized, there was an article from a Euro MS organization highlighting MS. I remember pointing out the oddity of the source, and suggesting it was strategically released to bring attention to the compound. I don't recall anyone else on this board questioning the connection. Why now? MS has been regularly mentioned on this board as a legitimate indication for anatabine citrate, which makes pointing out this minute aspect of the article as an 'error', ridiculous.

My remark was here: #msg-110570662

The story was linked here (by Leifsmith): #msg-110555211

And here is the article (posted in February):

http://www.ms-uk.org/emergingtherapies

Could anatabine citrate be a used as a multiple sclerosis therapy?
(03/02/15)
Drug development company Rock Creek Pharmaceuticals has announced a new clinical trial application with the Medicines Healthcare Products Regulatory Agency (MHRA) has been approved. The company is set to proceed with a Phase I study of Anatabine Citrate, a chemical that is found naturally in aubergine, potatoes, green tomatoes and other members of the Solanaceae family of plants, as well as in tobacco and tobacco smoke. The chemical is known for its anti-inflammatory properties unique from other anti-inflammatory drugs on the market, and may benefit patients with multiple sclerosis (MS).

The Phase I study will evaluate Anatabine’s pharmacokinetic profile in the form of modified release formulation prototypes, and its safety and tolerability profiles in healthy volunteers. The first two parts will involve an open-label, non-controlled, single-dose study on 14 healthy participants, using six formula variations, with each administered dose spaced 7-14 days apart. The variations will be distinct in dose and duration of therapeutic action. This will allow the company to determine which formulation is most ideal, based on safety. The third and last part of the Phase I study will be a double-blind, placebo-controlled, seven-day multiple dose study of the identified optimal formulation in healthy subjects.

“We are delighted to have been granted regulatory approval to begin our Phase I studies in the UK. This is the first clinical phase for our lead drug and will focus on safety and tolerability of six different formulations, five of which have modified release profiles and are of different doses. We look forward to generating our first human clinical data under this CTA,” said Rock Creek Pharmaceuticals CEO Dr Michael Mullan.

Rock Creek’s UK-based partner, Quotient Clinical, is set to begin enrollment of healthy subjects this month. While the company expects the study to stretch well into August, they expect to have a significant amount of research findings by mid-2015. Rock Creek also announced Quotient Clinical will be utilizing its RapidFACT® (Rapid Formulation development And Clinical Testing) service to hasten the development of these novel, oral, modified release formulations that have been co-developed between the two companies.

Source: Multiple Sclerosis News Today © BioNews-tx.com 2015 (03/02/15)

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