Cb-03-01 Dose Response Study Update

[ThanksGramps]

Cassiopea just released some info about the status of Breezula (CB-03-01) dose ranging trial. Here are the highlights (copied from their presentation):

Single 12-month study with interim analysis at 6 months
• Male subjects 18-55 years of age with mild to moderate Androgenetic Alopecia
• Co-Primary Endpoints:
o Changes from Baseline in TAHC [in number of non-vellus hairs] at Month 12
o The subject’s evaluation of treatment benefit via the HGA question at Month 12
• 400 subjects, 80 per treatment arm
• 5 arms: 2.5%, 5.0%, 7.5%, vehicle BID and 7.5% QD
• CRO: bioskin; 6 German sites and 1 Back up site
• First Patient In June 2017
• 326 of 400 patients enrolled as of 3 Nov 17
• Enrollment should be complete by year end 2017
• Interim results due 2Q 2018 and Topline 12 month results due 4Q 2018

Also, here's a link to the ingoing clinical study details: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003733-23/DE

 

[mr_robot]

Looks like a very through clinical trial, hoping that this is stuff wont go system but this is something they seem to be testing for and are minded about:

7. Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index < 1%) would be to agree to use implants, injectables, combined oral contraceptives, some intrauterine devices, or be postmenopausal (defined as amenorrhea greater than 12 consecutive months in women 50 years of age or older), be surgically sterile (hysterectomy, bilateral tubal ligation [at least six months prior], or bilateral oophorectomy). For males, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception.

 

[BaldyBalderBald]

Looks like a very through clinical trial, hoping that this is stuff wont go system but this is something they seem to be testing for and are minded about:

Yes, they better be, topical androgen receptor antagonists are better than androgen synthesis inhibitors, but still antiandrogens.
I'm glad they are aware and minded about it actually

 

[fuDHTck]

I really like Cassiopea\Cosmo. They are taking their time but so far they have always been on schedule and they are really open with their updates. I know this won't be a cure but hopefully it can give us a safe alternative to oral Finasteride.

I can see myself using Polichem Finasteride and Breezula in a few years. Hopefully Brotzu too (Fidia could learn something from the other Italian company, Cassiopea).

 

[Jonnyyy]

I really like Cassiopea\Cosmo. They are taking their time but so far they have always been on schedule and they are really open with their updates. I know this won't be a cure but hopefully it can give us a safe alternative to oral Finasteride.

I can see myself using Polichem Finasteride and Breezula in a few years. Hopefully Brotzu too (Fidia could learn something from the other Italian company, Cassiopea).

What's the difference between polichem and Breezula?

 

[jamesbooker1975]

What's the difference between polichem and Breezula?

Polichem is just finasteride with a """""novel""""" vehicle . Breezula is a """new""" drug that have being on testing since around 10 years ago .

 

[BaldyBalderBald]

What's the difference between polichem and Breezula?

Breezula is an androgen receptors antagonists, not a 5AR inhibitor like finasteride

 

[abcdefg]

This is really thing we need for male pattern baldness maybe to compliment propecia and existing big 3. The big 3 plus this might be able to prevent further male pattern baldness. Unfortunately its a long wait to see