Acne, CB-03-01, Cosmo Pharmaceuticals, Hirsutism, Topical Antiandrogen

CB-03-01

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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: now known as Breezula). It is a topical anti-androgen type molecule that is as yet not approved for sale and is still undergoing clinical trials.

CB-03-01

CB-03-01 is manufactured by Italy-based Cassiopea (Edit: acquired by Cosmo Pharmaceuticals in 2021), 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.

Regenerative Medicine, Shinya Yamanaka, Stem Cells

Japan’s New Laws to Fast Track Stem Cell Therapies

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Japan has been at the forefront of regenerative medicine research for a number of years, partly due to the fact that its population is rapidly aging and declining too. The country is also at the forefront of robotics related research for similar reasons. A 2013 article from Japan projected stellar growth in the local regenerative medicine sector.

Japan’s Fast Tracking of Stem Cell Therapies

On November 20th 2013, Japan’s parliament passed two groundbreaking laws that aim to speed up the approval process for regenerative medicine involving stem cells.

One of the country’s foremost scientists, Dr. Shinya Yamanaka (together with Dr. John Gurdon), received a Nobel Prize in 2012 for his discovery on how to transform ordinary adult skin cells into cells that act like embryonic stem cells and can then develop into virtually any other type of cell in the body. Dr. Yamanaka called these cells induced pluripotent stem cells, or iPS cells.

Japan is now leading the world in this area. The country’s scientists have undertaken many pioneering procedures in recent years to restore eyesight using iPS cells.

What does all this mean when it comes hair loss research?

Time consuming stage III clinical trials that we see in the US will essentially be skipped in Japan. Especially for autologous procedures. This is excellent news, especially since Shiseido (Japan) will be starting stage II clinical trials of Replicel (Canada)’s RHC-01 product in the first half of 2015. These trials will last for one year, and it is therefore even possible that Shiseido can bring this product to market in Japan as early as 2017. This is a best case scenario of course and assumes the the stage II trials show good results.

Japan is holding the important BioJapan 2014 World Business Forum this coming week, and Replicel is scheduled to present there on October 15, 2014. More importantly, Replicel’s team “will be meeting with Shiseido to discuss progress on their RCH-01 clinical trial and to view their purpose-built facility on Kobe Island.”

I have mentioned this a few times before on this blog, and will repeat. We in the west will likely have to travel to Asia when the treatment finally arrives, even if it is based on western technology.