Category Archives: Breezula

Update on Breezula (aka CB-03-01)

In 2014, I wrote about a new yet to be released topical antiandrogen product called CB-03-01. Historically, antiandrogen products have usually been ingested orally and often led to adverse side effects. Early reports suggest that topical CB-03-01 has no significant side effects.

In 2015, the Italian company (Cosmo Pharmaceuticals) that was compounding CB-03-01 changed the product’s name to the unusual Breezula.  Moreover, Cosmo itself was renamed as Cassiopea.  I wrote about those developments here.

Phase 2 Results

Yesterday, Cassiopea released an interesting PowerPoint presentation summarizing 2015 and projecting the outlook for 2016.  For us hair loss sufferers, pages 18-22 summarizing Breezula’s Phase 2 Proof of Concept (PoC) results is the most important section.

To summarize in brief:

  • 95 patients were enrolled in a double blind study that lasted for 6 months and ended in December 2015.
  • 31 patients were on Breezula 5%, 31 patients were on Minoxidil 5% and 33 patients were given nothing except a vehicle (i.e., placebo).
  • Of the 95 patients, 78 lasted till the end of the 6-month treatment period, and 73 of those were deemed to have completed the protocol without any violations.  Of those 73 patients, 23 were on Breezula, 25 were on Minoxidil and 25 were on a placebo.  A fairly even distribution.
  • 39 percent of patients on Breezula had at least some improvement in hair growth, compared to 36 percent of those on Minoxidil.  26 percent of patients on Breezula had at least some worsening in hair growth, compared to 16 percent of those on Minoxidil.  Status quo was maintained in 35 percent of Breezula patients versus 48 percent of Minoxidil patients.
  • Later in 2016, Cassiopea will commence further dosing related trials for Breezula.  I wonder if they will compare the effectiveness of higher doses to the effectiveness of the much more rarely used Minoxidil 15%?

I was pleased to see the results. Overall, Breezula seems as good as Minoxidil, and since the latter is not an anti-androgen, we can use both products topically on our scalp for two separate positive effects. Perhaps we can also add topical Bimatoprost and topical Finasteride to that combo later this year, and then we would have a quartet of topical products, each tackling a different mechanism of balding.

Of course Breezula is still years from release (even if we assume they can speed up phase 3 trials like is the case in Japan, with newer regulations), but some people on hair loss forums are purchasing it illegally or even making it at home. I cannot ever recommend that.  An even more optimistic scenario is the addition of Samumed’s topical SM04554 to the mix whenever that comes out.  It would be funny if in 2020, I started applying a quintet of topical products to my scalp and then suddenly a simple cure for hair loss came out that made all those topical products obsolete.

For younger people who have only been balding for a few years or less, such incremental developments are probably not too exciting. For those of us who have been following the hair loss industry for many more years, it is very pleasing to finally see new products arriving.  It is ridiculous that there have only ever been two products officially FDA approved to tackle hair loss — 1) Finasteride and 2) Minoxidil.

***Note that on page 8 of the PowerPoint presentation they have labeled CB-03-01 as “Winlevi” and CB-03-11 as “Breezula”.  Winlevi (for acne) and Breezula (for hair loss) contain the same key antiandrogen ingredient (a steroid belonging to the family of cortexolone derivatives), but in different formulations.

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.