Category Archives: Replicel

Kythera Biopharmaceuticals, Replicel, Setipiprant

Kythera and Replicel Updates

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Replicel’s latest presentation from BioAsia 2015 in Japan is out.  I was not planning on writing much about Replicel for a few months, but it seems like they keep making interesting presentations almost every month with some new information each time. Moreover, people in the hair loss chat on this site keep asking about Replicel.

At the start of the presentation, I liked reading the quote from Japanese prime minister Shinzo Abe that was made in early 2014:

Japan is on the leading edge in regenerative medicine. We will make it possible to generate cells at private-sector factories.

Page 16-19 has most of the RCH-01 and 6-month hair growth related information.  12-month results with higher doses and frequency will likely lead to better outcomes as has been conjectured in the past.  The last part of the presentation has more details on Japan’s regenerative medicine reforms (via Abenomics related policy changes) and early-to-market reforms.

More interesting to me was this week’s news regarding Kythera Biopharmaceuticals’ ATX-101 injectable drug that reduces double chins receiving unanimous backing from an independent panel of experts.  It is thus likely that the FDA will approve this product in the next several months, and if effective, it could in some cases become a better alternative to liposuction.  In fact ATX-101 (brand name Kybella) would be the first ever drug to be approved by the FDA to reduce localized fat deposits.  This company’s stock price movement is definitely worth following.

The main reason I found this news interesting is because just over a month ago, Kythera Biopharmaceuticals acquired global rights to Setipiprant, a PGD2 antagonist.  According the company’s highly informative 2013 annual report and per various parts of the company’s website, it seems like hair and fat are two of the main areas in which Kythera will be focusing on in the coming years, with an overall focus on the human face.  The company has a long-term goal of becoming a major player in the aesthetics industry.

For those interested, Kythera has an investor conference call and webcast later today at 4:30 pm ET.

Dermal Sheath Cup Cells, Lee Buckler, RCH-01, Replicel

Yet Another RepliCel Interview

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RepliCel
RepliCel.

New RepliCel Interview

We have yet another new RepliCel interview. This one is with Lee Buckler, the vice president of business and corporate development for RepliCel.

How RepliCel Is Harnessing the Awesome Power of Cell Therapy

We are given a few more details regarding the company’s pending phase II trials, including frequency of injections. Mr. Buckler also mentioned Japanese licensing and clinical trial partner Shiseido a few times.

The two companies are preparing to launch a very significant Phase 2 trial in Japan using RCH-01 dermal sheath cup (DSC) cells for hair regeneration. The trials will involve 160 Japanese patients. The hair regrowth procedure itself is a cellular injection cell transplant rather than a hair transplant.

The cells are taken from a cell population located at the base of the hair follicle. These DSC cells are used to produce the company’s RCH-01 product.

The cells are sourced from hair follicles in the back of the scalp between the ears. This area is known as the “permanent donor zone” in hair transplantation terminology. This hair is insensitive to the damaging effects of dihydrotestosterone (DHT). At least in the vast majority of people.

I disagree with Lee’s statement that:

Second, hair transplantation only achieves a satisfactory result when performed by a gifted surgeon, of which there are few.

In my opinion, there are at least several hundred great hair transplant surgeons in the world today, and the ARTAS robot is enabling numerous strip surgeons to become “gifted” when it comes to FUE. I think in most cases, satisfaction is more closely related to expectations rather than surgeons these days. A Norwood 5 will not be happy if he expects a Norwood 1 type final result after a hair transplant. Because strip hair transplant surgery is becoming obsolete, scarring and nerve damage are also no longer as big an issue (albeit still possible) with FUE hair transplants.

Another major reason for hair transplant patient dissatisfaction is that the existing hair in the transplanted area will continue to die, even when taking Finasteride for many people. So in essence, the result immediately post transplant will only continue to slowly worsen in most hair transplant patients.

And in the long run, even the “permanent” transplanted hair is not always permanent, as can be seen in many older people’s totally denuded or sparse donor regions. In fact even in my 30s, my supposedly “permanent” donor hair at the back of my scalp is significantly less dense than in was in my 20s.