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 17a-propionate (CB-03-01) for the treatment of androgenetic alopecia. The study results show that CB-03-01, applied to the scalp through iontophoresis, was more effective than cyproterone-acetate and 17a- 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 5a-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% 17a-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.
Parameter CB-03-01 (1%) CB-03-01 (5%) Cyproterone ac. (1%) 17a-estradiol (1%) Basal T1 T2 Basal T1 T2 Basal T1 T2 Basal T1 T2 Follicular density (n°/ cm2) 71 89 109 73 88 111 70 82 96 74 84 98 Hair diameter (mm) 0.41 0.73 0.88 0.66 0.74 0.91 0.51 0.61 0.74 0.53 0.65 0.73 Pull test (score) 3 1 1 3 1 1 3 2 2 3 1 1 Sebometric evaluation High Mid Low High Mid Low High Mid Low High High High Subjects improved (%) --- 76 85 --- 79 85 --- 59 66 --- 61 69 T1= one week after treatment completion; T2= four weeks after treatment completion.
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 5a-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.
Mo Noonan Senior Manager Financial Communications
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