Category Archives: Cosmo Pharmaceuticals

Brief Items of Interest, April 2015

Although a lot of important developments have occurred in the hair loss world in the past several weeks, I have not been excited by most of them. I did not think any of the below warranted a separate post.

— A few days ago, the New York Times had a fairly detailed and interesting article on hair loss, with the focus largely being on women’s hair loss. The article includes quotes from well known experts frequently mentioned on this blog such as Dr. Joseph Greco, Dr. Carlos Wesley and Dr. Angelo Christiano. It seems like Dr. Christiano has helped start a company (called Rapunzel of course!) where she will focus on hair multiplication via cell culturing. I am not too excited about this as yet since clinical trials are 1-2 years away, and in essence this is yet another “cure is five years away” type venture (and even that timeline is optimistic based on the assumptions that she raises the requisite funds and that each stage of clinical trials progresses as planned). The one redeeming factor is that Dr. Christiano is very passionate about helping women with hair loss, perhaps largely because she also suffers from hair loss and wears a wig.

— The other interesting item from the above mentioned New York Times article was an explanation on why Latisse (Bimatoprost) will probably not work as well on the head as it does on eyelashes.   According to the Cleveland Clinic’s Dr. Melissa Piliang, a well known hair loss researcher and dermatologist, Latisse works by shifting hair that is in a resting phase into hair that is in a growth phase. However, while 70 percent of eyelash hair is usually in resting phase, only 10-20 percent of scalp hair is usually in resting phase. I wonder if that 10-20 percent potential new growth is enough to make Bitamoprost at least as good as Minoxidil when it comes to scalp hair regrowth?

— Cellmid, a company that I discussed earlier this year, just announced very good results from an independently conducted trial of its FGF-5 inhibiting drug évolis ONE. I would be a lot more excited about this product if were not based on naturally occurring botanical extracts and if there were more positive anecdotal forums posts from existing Australian users of the product. I just do not believe that any natural product can considerably benefit hair loss, especially when it comes to regrowth.  In any case, their CEO Maria Halasz has Tweeted to me that the product will be in pharmacies (I presume US-based ones) in May.

— Italian company Cosmo Pharmaceuticals changed the name of its yet to be approved CB-03-01 topical anti-androgen product to Breezula per a March 25, 2015 detailed company presentation. Strange choice of name. The company also changed its own name to a more Italian sounding Cassiopea in April 2015.

— The two main stories in the hair loss world last year both involved JAK inhibitors reversing alopecia areata. The before and after photos in both cases (see bone marrow cancer drug Ruxolitinib and arthritis drug Tofacitinib) were mind blowing and took the global media by storm. This month, yet another JAK inhibitor (an Israeli developed cancer drug Baricitinib) proved to have similar results, but the publicity surrounding this development was modest this time.

— Although related to the skin rather than to hair, cosmetics giant L’Oreal ‘s and 3D organ printing giant Organovo’s newly announced partnership in research is one to watch closely. The human skin is very closely related to hair, and L’Oreal has already made its presence felt in the hair world due to its much hyped yet to be released gray hair prevention pill (which has to be taken forever, and which won’t help if you already have gray hair).

— Finally, I was surprised that the crazy Dr. Sergio Canavero of the full body transplant (or “head transplant”, as has been falsely named by much of the media) fame has already managed to find a patient. So they are likely to proceed with this insanity in 2016. Even crazier, it seems like Dr. Canavero got over 100 volunteers asking him to be the first person to get a new body. I cannot imagine that this will ever work, but it is still worth seeing the below video. More on Valery Spiridonov. You can also read this interview with him and this one with Dr. Canavero.

CB-03-01

Due to the numerous news items, conferences and other hair loss research related developments in recent months, I have had to delay covering an important product until today.  This product, as evident from the title of this post, is CB-03-01 (Edit: name changed to Breezula), a topical anti-androgen type molecule that is as yet not approved for sale and is still undergoing clinical trials.

CB-03-01 is manufactured by Italy-based Cosmo Pharmaceuticals (Edit: name changed to Cassiopea), a company that is primarily focused on treating Inflammatory Bowel Diseases (IBD) and colon cancer.  Strangely enough, the company has also been active in the seemingly entirely unrelated skin disorders area. Cosmo licensed the CB-03-01 product to Medicis (US) in early 2012, but Valeant (Canada) then purchased Medicis later in the same year.  Per some reports, Valeant still seems to be interested in the product, although it has an option for right of refusal in case of Cosmo re-licensing.

The CB-03-01 product will supposedly cure (or improve?) acne, hirsutism and male pattern baldness (MPB).  This very useful January 2013 Cosmo Presentation has a number of pages on CB-03-01 for both acne and hair loss applications.  My favorite is the diagram on page 48.  It shows that while Finasteride and Dutasteride work on preventing the conversion from Testosterone to DHT, CB-03-01 does not mess with that perhaps important hormonal mechanism, but rather, acts at the receptor site (in their own words on page 51: “antagonize the DHT/T interaction at these receptors”).

The one discouraging aspect of the above presentation’s page 48 diagram is that it seems to compare CB-03-01’s mechanism of action with that of Cyproterone Acetate and Flutamide, neither of which have turned out to be of any major help for most people when it comes to hair regrowth (and mixed testimonials when it comes for hair maintenance).  Luckily, while those two drugs are taken orally, CB-03-01 will be applied topically and most likely result in far fewer side effects.  Note that CB-03-01 is technically known as Cortexolone 17α-propionate according to this source.

Key Events Affecting CB-03-01 (parts of below directly pasted from their site with my modifications in some places)

  • IND granted in Q1 2012 for acne treatment.
  • Phase II dose escalating clinical trials for acne treatment completed in H1 2014.
  • An FDA meeting for discussion of the phase III acne trial design is expected at the end of 2014 or beginning of 2015.
  • The first patient in for a “proof of concept” phase II trial for alopecia is expected in October 2014.
  • Patents have been granted in the US and expire in 2023 and 2030.

Cosmo’s half-year 2014 report has more recent updates, including a useful clinical trial and schedule of release diagram for all its key products on page 14.

I will probably have more on CB-03-01 in coming posts, as there is a lot of discussion about this on the forums and I have not had much time to process most of it, especially Desmond’s recent thread.