What is Taking Intercytex So Long? Here\'s the timeline

Stem cell; cell based hair therapy
1

Hey all,

I think it’d be useful to review Intercytex’s actual timeline for completion of ICX-TRC. Since the procedure is injections plus waiting 3 months, you’d think they could get the trials done quickly. However there have been some delays – though we don’t know the reasons for them. Perhaps the DTI “robot” needed some fine-tuning? Who knows?

Regardless, here’s the timeline I can piece together:

October 2003: Began Phase I trials on 7 people.

December 2005 (or earlier in 2005): Finished Phase I trials on 7 people; results showed high safety and promising efficacy, with increased hairs in 5/7 clients.

September 2006: Began Phase IIa trials on 5-7 people, finished by at least September 2007; results showed relatively poor efficacy, with ICX-TRC failing to work in 3 people.

Summer 2007: Begin Phase IIb trials on 5-7 people (assuming people are injected 6-12 weeks before September 25th, as findings would suggest); results showed promising efficacy, with ICX-TRC working in all subjects to some extent.

Summer 2007: Begin Phase IIc trials on 8 people (recruitment began over the summer); results uncertain.

If you look at the following link you’ll see that Intercytex hoped to start Phase II by fall/winter of 2004: http://www.intercytex.com/icx/news/releases/pr2004/2004-05-06/

Why did they wait so long to inject people with ICX-TRC in Phase II?

Best,
BB

2

» Hey all,
»
» I think it’d be useful to review Intercytex’s actual timeline for
» completion of ICX-TRC. Since the procedure is injections plus waiting 3
» months, you’d think they could get the trials done quickly. However there
» have been some delays – though we don’t know the reasons for them.
» Perhaps the DTI “robot” needed some fine-tuning? Who knows?
»
» Regardless, here’s the timeline I can piece together:
»
» October 2003: Began Phase I trials on 7 people.
»
» December 2005 (or earlier in 2005): Finished Phase I trials on 7 people;
» results showed high safety and promising efficacy, with increased hairs in
» 5/7 clients.
»
» September 2006: Began Phase Ia trials on 5-7 people, finished by at least
» September 2007; results showed relatively poor efficacy, with ICX-TRC
» failing to work in 3 people.
»
» Summer 2007: Begin Phase Ib trials on 5-7 people (assuming people are
» injected 6-12 weeks before September 25th, as findings would suggest);
» results showed promising efficacy, with ICX-TRC working in all subjects to
» some extent.
»
» Summer 2007: Begin Phase 1c trials on 8 people (recruitment began over the
» summer); results uncertain.
»
»
» If you look at the following link you’ll see that Intercytex hoped to
» start Phase II by fall/winter of 2004:
» http://www.intercytex.com/icx/news/releases/pr2004/2004-05-06/
»
» Why did they wait so long to inject people with ICX-TRC in Phase II?
»
» Best,
» BB

Starting with Sept 2006, you might want to say Phase IIa/b/whatever.

I think they took time to make sure cancer didn’t grow from it.