Home | News | Find a Doctor | Ask a Question | Free

Cosmo reports exciting results in P.O.C. alopecia study


#1

http://www.cosmopharmaceuticals.com/csm/news/press/pr2010/20101006/

Lainate, Italy – 6 October 2010 – Cosmo Pharmaceuticals S.p.A. (“Cosmo”) (SIX: COPN) announced today the successful conclusion of its proof of concept trial of its new chemical entity cortexolone 17alpha-propionate (CB-03-01) for the treatment of androgenetic alopecia. The study results show that CB-03-01, applied to the scalp through iontophoresis http://en.wikipedia.org/wiki/Iontophoresis , was more effective than cyproterone-acetate and 17alpha-estradiol in the improvement of the follicular density, the hair shaft diameter, the pull test, and in reducing sebaceous gland size and, as a consequence, sebum production.

Mauro Ajani, Chief Executive Officer of Cosmo Pharmaceuticals, said: “We are extremely pleased with this result. This is the first step towards establishing CB-03-01 as an effective, topically applied anti-androgen and could therefore mark a major breakthrough for all men and women affected by androgenetic alopecia. Currently the only FDA approved anti-androgen for this condition is Propecia, a 5alpha-reductase inhibitor, which is only suitable for men and is taken as a tablet and can have significant side effects. Currently no effective treatment FDA approved is available for women which tend to suffer much more than men if they have alopecia.”

The study evaluated the efficacy of CB-03-01 in 40 men with androgenetic alopecia grade 1-4 according to the Hamilton scale, and in 30 post-menopausal women with androgenetic alopecia grade 1 according to the Ludwig scale. Prior to treatment, follicle density, hair thickness, a pull test, and sebum production were measured. All subjects were then given 5 treatments (in sessions once or twice a week) of either 1% CB-03-01, 5% CB-03-01, 1% ciproterone-acetate or 1% 17alpha-estradiol. Each volunteer was then re-analyzed one week and one month after the last treatment.
The design of the next clinical phase is planned within the year end.

About CB-03-01
CB-03-01 is a new chemical entity that acts at the level of the skin androgen receptor, blocking testosterone and di-hydrotestosterone from binding to the receptor in the cell. The molecule additionally has a moderate anti-inflammatory activity similar to hydrocortisone, and quickly metabolizes to cortexolone, a body own safe substance, in blood.

About androgenetic alopecia
Androgenetic alopecia is caused by testosterone which is produced by the testicles (in men) and the adrenals (men and women). Testosterone is converted to di-hydrotestosterone by the enzyme 5alpha-reductase. Both testosterone and di-hydrotestosterone bind to the cell androgen receptors of the hair follicle where they impair the hair cycle and induce follicle miniaturization. Adults have between 85,000 and 150,000 hairs. 80-90% of these are in the growth phase (anagen), where cells continuously split and create the hair shaft. This phase lasts two to six years. It is presumed that testosterone and di-hydrotestosterone cause the anagen phase to shorten. In the following catagen phase the hair root cells die and the hair stops growing. In the final telogen phase the hair falls out.
It is presumed that 40% of all men and 40% of all post-menopausal women suffer androgen-induced hair loss.

About iontophoresis
Iontophoresis is a non-invasive method of propelling high concentrations of a charged substance, normally a medication or bioactive agent, transdermally by a repulsive electromotive force using a small electrical charge applied to an iontophoretic chamber containing a similarly charged active agent and its vehicle. One or two chambers are filled with a solution containing an active ingredient and its solvent, also called the vehicle. The positively charged chamber, called the anode, will repel a positively charged chemical, whereas the negatively charged chamber, called the cathode, will repel a negatively charged chemical into the skin. Iontophoresis is well classified for use in transdermal drug delivery. Unlike transdermal patches, this method relies on active transportation within an electric field

About Cosmo Pharmaceuticals
Cosmo is a speciality pharmaceutical company that aims to become a global leader in optimised therapies for selected Gastrointestinal and topically treated Skin Disorders. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. Cosmo’s first MMX® product that has reached the market is Lialda® / Mezavant® / Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the intestines.

Cosmo Pharmaceuticals’ research day 2010
Cosmo will be hosting a research and development day in Zurich on 30 November 2010. For more information and pre-registrations, please contact Florian Zingg, florian.zingg@irfcom.ch / phone +41 43 244 81 41.

Contact
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals S.p.A.
Tel: +39 331 570 1679

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.


#2

Nice but I guess they are 10 years away even if they promise good… I am right?


#3

» Nice but I guess they are 10 years away even if they promise good… I am
» right?

You can already make a topical anti-androgen.

Just dissolve a few tablets of finasteride in a mixture of water and alcohol (no not rubbing alcohol because that is poisonous, try vodka) and rub in onto your bald nugget.

dissolve the tablet only when you intend to use it immediately thereafter otherwise is might denature sitting there dissolved in alcohol.

Rub it in after a hot shower when your pores have opened up and that should get some finasteride molecules through.


#4

» Nice but I guess they are 10 years away even if they promise good… I am
» right?

I’ve been following this company for a while, this was supposed to be an acne cream and it was quite far along in trials already.

I hope they just go ahead and release it as an acne treatment, it’ll probably come to market a lot sooner.


#5

»
» Some of the information contained in this press release contains
» forward-looking statements. Readers are cautioned that any such
» forward-looking statements are not guarantees of future performance and
» involve risks and uncertainties, and that actual results may differ
» materially from those in the forward-looking statements as a result of
» various factors. Cosmo undertakes no obligation to publicly update or
» revise any forward-looking statements.
» ---------------------------------

In other words, it won’t be available any time soon.:frowning:


#6

»
» In other words, it won’t be available any time soon.:frowning:

It sounds pretty simple i am sure we can find a way to duplicate the technology if we really want to! We just have to go the extra mile (possibly a green one)


#7

Just bumping this to get the spam off the page.


#8

» Just bumping this to get the spam off the page.

Looks promising, but, is far (probably anywhere from 5-10yrs) from market…if it survives clinical trials.


#9

» http://www.cosmopharmaceuticals.com/csm/news/press/pr2010/20101006/
»
» Lainate, Italy – 6 October 2010 – Cosmo Pharmaceuticals S.p.A. (“Cosmo”)
» (SIX: COPN) announced today the successful conclusion of its proof of
» concept trial of its new chemical entity cortexolone 17alpha-propionate
» (CB-03-01) for the treatment of androgenetic alopecia. The study results
» show that CB-03-01, applied to the scalp through iontophoresis
» http://en.wikipedia.org/wiki/Iontophoresis , was more effective than
» cyproterone-acetate and 17alpha-estradiol in the improvement of the
» follicular density, the hair shaft diameter, the pull test, and in reducing
» sebaceous gland size and, as a consequence, sebum production.
»
» Mauro Ajani, Chief Executive Officer of Cosmo Pharmaceuticals, said:
» “We are extremely pleased with this result. This is the
» first step towards establishing CB-03-01 as an effective, topically applied
» anti-androgen and could therefore mark a major breakthrough for all men and
» women affected by androgenetic alopecia. Currently the only FDA approved
» anti-androgen for this condition is Propecia, a 5alpha-reductase inhibitor,
» which is only suitable for men and is taken as a tablet and can have
» significant side effects. Currently no effective treatment FDA approved is
» available for women which tend to suffer much more than men if they have
» alopecia.”

»
» The study evaluated the efficacy of CB-03-01 in 40 men with androgenetic
» alopecia grade 1-4 according to the Hamilton scale, and in 30
» post-menopausal women with androgenetic alopecia grade 1 according to the
» Ludwig scale. Prior to treatment, follicle density, hair thickness, a pull
» test, and sebum production were measured. All subjects were then given 5
» treatments (in sessions once or twice a week) of either 1% CB-03-01, 5%
» CB-03-01, 1% ciproterone-acetate or 1% 17alpha-estradiol. Each volunteer
» was then re-analyzed one week and one month after the last treatment.
» The design of the next clinical phase is planned within the year end.
»


»
» About CB-03-01
» CB-03-01 is a new chemical entity that acts at the level of the skin
» androgen receptor, blocking testosterone and di-hydrotestosterone from
» binding to the receptor in the cell. The
» molecule
additionally has a moderate anti-inflammatory activity
» similar to hydrocortisone, and quickly metabolizes to cortexolone, a body
» own safe substance, in blood.
»
» About androgenetic alopecia
» Androgenetic alopecia is caused by testosterone which is produced by the
» testicles (in men) and the adrenals (men and women). Testosterone is
» converted to di-hydrotestosterone by the enzyme 5alpha-reductase. Both
» testosterone and di-hydrotestosterone bind to the cell androgen receptors
» of the hair follicle where they impair the hair cycle and induce follicle
» miniaturization. Adults have between 85,000 and 150,000 hairs. 80-90% of
» these are in the growth phase (anagen), where cells continuously split and
» create the hair shaft. This phase lasts two to six years. It is presumed
» that testosterone and di-hydrotestosterone cause the anagen phase to
» shorten. In the following catagen phase the hair root cells die and the
» hair stops growing. In the final telogen phase the hair falls out.
» It is presumed that 40% of all men and 40% of all post-menopausal women
» suffer androgen-induced hair loss.
»
» About iontophoresis
» Iontophoresis is a non-invasive method of propelling high concentrations
» of a charged substance, normally a medication or bioactive agent,
» transdermally by a repulsive electromotive force using a small electrical
» charge applied to an iontophoretic chamber containing a similarly charged
» active agent and its vehicle. One or two chambers are filled with a
» solution containing an active ingredient and its solvent, also called the
» vehicle. The positively charged chamber, called the anode, will repel a
» positively charged chemical, whereas the negatively charged chamber, called
» the cathode, will repel a negatively charged chemical into the skin.
» Iontophoresis is well classified for use in transdermal drug delivery.
» Unlike transdermal patches, this method relies on active transportation
» within an electric field
»
» About Cosmo Pharmaceuticals
» Cosmo is a speciality pharmaceutical company that aims to become a global
» leader in optimised therapies for selected Gastrointestinal and topically
» treated Skin Disorders. The Company’s proprietary clinical development
» pipeline specifically addresses innovative treatments for IBD, such as
» Ulcerative Colitis and Crohn’s Disease, and Colon Infections. Cosmo’s first
» MMX® product that has reached the market is Lialda® / Mezavant® /
» Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and
» Shire Limited. Cosmo’s proprietary MMX® technology is at the core of the
» Company’s product pipeline and was developed from its expertise in
» formulating and manufacturing gastrointestinal drugs for international
» clients at its GMP (Good Manufacturing Practice) facilities in Lainate,
» Italy. The technology is designed to deliver active ingredients in a
» targeted manner in the intestines.
»
» Cosmo Pharmaceuticals’ research day 2010
» Cosmo will be hosting a research and development day in Zurich on 30
» November 2010. For more information and pre-registrations, please contact
» Florian Zingg, florian.zingg@irfcom.ch / phone +41 43 244 81 41.
»
» Contact
» Dr. Chris Tanner, CFO and Head of Investor Relations
» Cosmo Pharmaceuticals S.p.A.
» Tel: +39 331 570 1679
»
» Some of the information contained in this press release contains
» forward-looking statements. Readers are cautioned that any such
» forward-looking statements are not guarantees of future performance and
» involve risks and uncertainties, and that actual results may differ
» materially from those in the forward-looking statements as a result of
» various factors. Cosmo undertakes no obligation to publicly update or

When is ASC-J9 from Androscience going to be available? Isn’t that superior cause it actually DEGRADES the androgen receptors not block Alpha 5 reductase?
» revise any forward-looking statements.
» ---------------------------------


#10

Some info on AndroScience ASC-J9 from their press release. This is related to their acne-treatment development. But as I understand it, it’s the same substance as in their intended alopecia product:

AndroScience Corporation forms Strategic Alliance with Taiwan based Orient Europharma to Develop Novel Topical Acne Therapeutic

San Diego, CA May 20, 2010, AndroScience Corporation (ASC) announced today the forming of a strategic partnership with Orient Europharma Co. Ltd. (OEP) of Taiwan. The collaborative agreement centers on the clinical development and commercialization of ASC’s lead therapeutic candidate, ASC- J9® as a topical anti-acne product. Under terms of the agreement OEP is responsible for clinical study expenses related to an ASC-J9® phase IIb multi center trial in acne vulgaris. Scheduled to commence in September 2010, the 180 patients, double-blinded, placebo controlled efficacy study will be jointly conducted at clinical sites in Taiwan and the USA. Under this agreement OEP will secure rights to the ASC-J9® acne product as the exclusive commercialization partner for the core territories of Taiwan, Hong Kong, S. Korea, New Zealand, Australia, and other select markets served by OEP throughout Asia Pacific. ASC will support market approval of the ASC- J9® acne product in OEP designated territories by providing new drug approval materials following successful regulatory submission of the product in the US or Europe. Recently, ASC has initiated active discussions with US and European based multinational pharmaceutical companies to license the ASC-J9® acne product in major global markets.


#11

» Some info on AndroScience ASC-J9 from their press release. This is related
» to their acne-treatment development. But as I understand it, it’s the same
» substance as in their intended alopecia product:
»
»
» AndroScience Corporation forms Strategic Alliance with Taiwan based Orient
» Europharma to Develop Novel Topical Acne Therapeutic
»
» San Diego, CA May 20, 2010, AndroScience Corporation (ASC) announced today
» the forming of a strategic partnership with Orient Europharma Co. Ltd.
» (OEP) of Taiwan. The collaborative agreement centers on the clinical
» development and commercialization of ASC’s lead therapeutic candidate, ASC-
» J9® as a topical anti-acne product. Under terms of the agreement OEP is
» responsible for clinical study expenses related to an ASC-J9® phase IIb
» multi center trial in acne vulgaris. Scheduled to commence in September
» 2010, the 180 patients, double-blinded, placebo controlled efficacy study
» will be jointly conducted at clinical sites in Taiwan and the USA. Under
» this agreement OEP will secure rights to the ASC-J9® acne product as the
» exclusive commercialization partner for the core territories of Taiwan,
» Hong Kong, S. Korea, New Zealand, Australia, and other select markets
» served by OEP throughout Asia Pacific. ASC will support market approval of
» the ASC- J9® acne product in OEP designated territories by providing new
» drug approval materials following successful regulatory submission of the
» product in the US or Europe. Recently, ASC has initiated active discussions
» with US and European based multinational pharmaceutical companies to

This good news.I could understand why at this time there is no really effective hair restoring drug but I could never understand why there has been no really effective topical anti-androgen.
» license the ASC-J9® acne product in major global markets.