Make way for the hedgehog

[Tricia]

I know I post a lot of business news. But, this is exciting to me. Procter & Gamble is getting in with Curis to develop the hedgehog drug.

P&G, Curis partner in hair growth research
Monday September 19, 1:35 pm ET

Procter & Gamble Pharmaceuticals has entered into a research and development agreement with Curis, Inc. to study and develop possible treatments for hair growth regulation using Curis' Hedgehog agonist technology, Curis announced Monday.
Scientists at Curis Inc. (NASDAQ: CRIS - News) a therapeutic drug development company, have shown that small molecule Hedgehog agonists can induce hair growth.

P&G was granted a license to use the technology and Curis will have the option to co-develop, as well as retain rights to veterinary applications of the technology.

"Procter & Gamble's expertise in pharmaceutical development, combined with their solid track record in creating market-leading hair and skin care products, makes them an excellent choice as a partner for our hair program," said Daniel R. Passeri, Curis president and chief executive officer. "This is the second collaboration agreement structured to provide Curis possible co-development opportunities. Collaborating with major pharmaceutical companies to execute clinical programs is one way to build Curis' internal development capabilities to re-apply to our in-house programs."

Procter & Gamble Co. (NYSE: PG - News) has agreed to pay Curis a $500,000 initial payment and up to $2.8 million in pre-clinical milestones, contingent upon achievement of certain pre-clinical goals.

Curis scientists showed in a February study that a small molecule Hedgehog agonist, applied to the skin, triggered hair follicles from the resting to the growth phase of the hair cycle. They concluded that it may be effective in treating hair disorders such as male pattern baldness and female pattern hair loss.

About 80 million men and women in the United States suffer from hair loss.

Published September 19, 2005 by the Cincinnati Business Courier

[HairLossFight.com]

Wow, that's great news Tricia, thanks! P&G getting behind Curis could speed things up a bit. Let's hope they're successful!

Sam

[Jacob]

I don't know. It's always a Gamble with those guys.

I'll keep my day job.

That is good info though

[aboynamedme]

but how long would FDA approval take? i've heard various time estimations when it comes to drugs. i've also heard that phase two for the hedgehog is due to commence (under P&G) beginning in 2006. when does that put an actual treatment on the market? my hopes would be no more than two years in the making.

any thoughts on this? i don't know what kind of authority it would take, but updates (at least bi-annually) from P&G would be an awesome feature. if i were their PR people, i surely would reject the idea. after all, this IS the customer base they're looking to sell to.

wonderful find, Tricia.

and on another note, how does lee's pharm's TB4 topical look in comparison to something such as hedgehog? it's been a while since i've read the scientific literature about either. same effect or is one more preferable than the other? TB4 certainly is estimated to be released much sooner.

hope all is well with everyone!

-aboy

[Tricia]

Aboy,

Sorry. I missed your post and just noticed it today. I didn't think hedgehog was in FDA trials yet. I thought it was still pre-clinical. I'm not sure how hedgehog would compare to tb4.

Trials take a while. If everything goes smoothly, a drug can pass all 3 trials within 3 years and then after the drug passes Phase III there is at least 1 year before the drug can be marketed.

[HairLossFight.com]

Here's what Dr. Lee has to say about Curis:

http://www.morphollica.com/hairloss_exp ... wer749.php

Q. What is Curis?

A. Curis, Inc. (http://www.curis.com/index.php) is a therapeutic drug
development company. In September 2005, Curis announced the publication
of data reporting on the therapeutic efficacy of one of Curis'
proprietary Hedgehog pathway activators in an adult animal model of hair
growth. The results of the study show that a topically applied small
molecule agonist of the Hedgehog signaling pathway can stimulate the
transition of hair follicles from the resting (telogen) to the growth
(anagen) stage of the hair cycle. The Hedgehog signaling pathway is a
complex network of proteins that cells use to communicate by acting as
molecular switches. These results were published in the Journal of
Investigational Dermatology and expanded on those that were presented at
the February 2005 Annual Meeting of the American Academy of Dermatology.

Also in September 2005, Curis entered into an exclusive worldwide
research and development agreement with Procter & Gamble
Pharmaceuticals, a division of The Procter & Gamble Company, to evaluate
and develop potential treatments for hair growth regulation utilizing
Curis' Hedgehog agonist technology.

This is potentially very exciting news. Curis hopes that the Hedgehog
pathway activator will work wonders on thinning scalps of both males and
females. Hedgehog signaling appears to prompt the bodys multi-talented
stem cells to proliferate around the hair follicles, initiating hair
growth. To date, all FDA proven and approved medical treatments for
pattern hair loss consist of either topical minoxidil as a non-specific
promoter of hair growth or agents to decrease the amount and/or action
of DHT in the scalp. Treatment with a drug derived from Hedgehog
molecular signaling, which acts on the stimulation of the follicular
stem cells, has the potential of being much more potent than the current
treatments, which mainly aim to increase the size of the hair follicles
which have already miniaturized.

Richard Lee, M.D.
Regrowth, LLC
http://www.minoxidil.com