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

Possible new topical pharaceutical "cream" from Cosmo company


#1

Via a poster called Patagonia at h, l, t,

Cosmo successfully completes the first phase I clinical trial of its anti-androgen, CB-03-01, for the treatment of skin disorder

Cosmo successfully completes the first phase I clinical trial of its anti-androgen, CB-03-01, for the treatment of skin disorders

Lainate, Italy – September 2, 2008 – Cosmo Pharmaceuticals SpA (“Cosmo”) (SWX: COPN) announced today positive results from the first phase I clinical trial of its novel anti-androgen 1% cream, CB-03-01. The trial results showed that the drug was well tolerated both locally and systemically and devoid of measurable side effects for all the doses tested.

CB-03-01 is a new chemical entity, belonging to the family of cortexolone derivatives, patented by Cosmo as an anti-androgenic drug; the compound is indicated for the topical treatment of androgen-dependent skin disorders including Acne, Hirsutism or Androgenetic Alopecia.

The trial was designed as a randomized, double-blind, placebo-controlled, single ascending doses trial to assess drug safety, tolerability and pharmacokinetics following single dose administration. The trial was carried out at the Department of Clinical Pharmacology of the Medical University Hospital of Vienna, under the supervision of the main investigator Prof. Markus Muller. In the study, 3 doses of cortexolone 17a-proprionate (“CB-01-03”) were administered to 24 healthy male volunteers divided in to three cohorts. Each cohort included 2 subjects receiving only placebo cream on both forearms and 6 subjects receiving CB-03-01 1% cream on one forearm and placebo cream on the other forearm. Safety and tolerability assessments, as well as PK evaluations, were performed up to 36 hours following drug application.

CB-03-01 was shown to permeate the skin and to be quantifiable in the plasma of approximately 40% of the treated subjects: the maximum recorded concentration of the unchanged compound in plasma was below 10 ng/ml. In all subjects, CB-03-01 was undetectable 24-36 hours after dosing.

CB-03-01’s mechanism of action is the competition with Testosterone and DHT at the human androgen-receptor level. CB-03-01 is devoid of systemic anti-androgenic activity, as far as it does not inhibit gonadotropins hypersecretion, and it possesses a moderate anti-inflammatory activity. In preclinical studies, CB-03-01 was shown to be not mutagenic and rapidly metabolized to the parent cortexolone, a physiological substance lacking anti-androgen activity, by human plasma and skin. CB-03-01 has also been shown to be well tolerated and devoid of toxicity when applied repeatedly.

Commenting on today’s announcement, Mauro Ajani, CEO of Cosmo, said: “CB-03-01 is the first new chemical entity that Cosmo is developing and the first product that is not based on our innovative MMX™ technology. CB-03-01 has the potential to be the first topically effective anti-androgen treatment on the market and we look forward to initiating a phase II proof-of-concept trial later in the year

About acne, alopecia and hirsutism
Acne affects almost 45 million people in the USA i.e. around 16% of the population. The worldwide market for Acne is valued at over US$2.8 billion. Roaccutane™ of Roche had sales exceeding US$253 million in 2004 but these decreased following FDA warning for side effects.

Alopecia (androgen-induced hair loss in males) affects approximately 12% of all men over 20 years of age. Propecia™ (Merck), a systemically applied drug, had sales of US$405 million in 2007.

Hirsutism (androgen-induced growth of facial and/or body hair in women) affects about 10% of the female population. The world wide market remains largely undeveloped

Hope they have success with this potential topical receptor blocker in Phase 2.


#2

»
» Hope they have success with this potential topical receptor blocker in
» Phase 2.

Why do researchers continue to pursue the anti-andro route? Can it get much better than Dut? Or is the topical route a preferred delivery?


#3

» »
» » Hope they have success with this potential topical receptor blocker in
» » Phase 2.
»
» Why do researchers continue to pursue the anti-andro route? Can it get
» much better than Dut? Or is the topical route a preferred delivery?

They are looking for a topical with no internal side effects (libido, breast enlargement, etc). Its for acne, alopecia, hirsutism and other androgen-skin related disorders. Many more men would probably use a topical anti-androgen (especially if it could be formulated to come in a “mousse”) than take a pill internally.

If it works really well (like RU58841), it would probably be more effective for hirsutism and acne than dutasteride would be. It could also be used for women’s androgenic alopecia without affecting would-be mothers’ developing fetuses hopefully. That is, if its effective, etc.


#4

Everyone, raise your hand if you’re currently taking big doses of oral Spiro or oral Dut and not getting any side effects at all.

Everyone else in the room stands to get a considerable real-world benefit from a non-systemic topical AA.


#5

» Everyone, raise your hand if you’re currently taking big doses of oral
» Spiro or oral Dut and not getting any side effects at all.
»
»
»
» Everyone else in the room stands to get a considerable real-world benefit
» from a non-systemic topical AA.

I’m taking .5 mg of Dut a day with no sides - very healthy libido, no gyno, etc. Started about 2.5 months ago to see if it was any more effective than Proscar. So far, can’t tell.


#6

We have seen that many members from this forum had side affects while using either Fin or Dut…

Personally, I 've tried Dut for 2 months, and despite some headaches I experienced after the 1st month, I also experienced increase in hair loss especially at the frontal part of the scalp…


#7

Lots of guys get no sides from Fin. Some even get no sides from Dut.

But I don’t think the point is even discussion-worthy. IMHO it is abundantly clear that both drugs have serious side-effect problems for a significant portion of their users.

I didn’t say all users. Maybe not even half . . . but it’s true for a significant portion of them.