Category Archives: Osman Kibar

Osman Kibar, Samumed

Samumed Expects 2021 or early 2022 FDA Approval

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I have covered Samumed (US) close to 20 times on this blog. In 2018, the company started Phase 3 clinical trials for its androgenetic alopecia (SM04554) topical product.

Samumed Pipeline 2019
Samumed pipeline. Androgenetic Alopecia is third from bottom.

Can Samumed Release Hair Loss Product in 2022?

Yesterday, Samumed’s CEO Dr. Osman Kibar gave an interesting interview to Fierce Biotech (h/t reader “John Doe”). The most relevant part of this interview for us is:

“Its alopecia treatment is close behind, with approval anticipated in late 2021 or early 2022.”

Not a surprise as far as time frame goes, but Mr. Kibar seems confident that they will get approval. I am assuming he agreed with the above sentence in the interview or was quoted as such.

Not sure if other CEOs “anticipate” approval chances before Phase 3 trials are complete. I am hoping that Samumed has seen good results during the first year of ongoing Phase 3 trials in order to warrant this confidence.

The interview also has some interesting information about the scientific reasoning behind why Samumed’s products are safe despite targeting the critical Wnt pathway.

Angela Christiano, ISHRS, JAK Inhibitors, L'Oreal, Osman Kibar, Pantelis Rompolas, Parsa Mohebi, Poietis, Rapamycin, Replicel, Shiseido, Turmeric

Brief Items of Interest, October 2016

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Hair loss news first:

— Update: A day after I wrote this post, CNN covered JAK inhibitors in a new article (in a pleasant surprise, they also looked at the androgenetic alopecia — AGA — angle). Usually, all these articles on JAK inhibitors only look at alopecia areata (AA). Yet again, Dr. Christiano says she is optimistic that JAKs could work on AGA patients (but only in a topical form). Dr. Brett King is not optimistic, but he is still testing it out (in a lotion form) on his AA patients (probably the ones who also have AGA).

In the above article, the one AA patient who they show with regrown hair after being on oral JAK inhibitors did not regrow hair that he lost to AGA, although it is impossible to tell whether he did not regrow 100 percent of his AGA hair loss or not. In any event, we will only know for sure about this once they test newer topical JAK inhibitors out so people should not get so emotional about this subject each time there are new developments. You should also not try to test your own topical version as even the experts are having a hard time developing the appropriate version. According to Dr. Christiano:

“Though she thinks men might have the same success with an ointment, she said the trick is that it has to penetrate properly. Compared with the paper-thin skin of mice, human skin is “much thicker, and it’s oily, and it’s deep, and it’s got a fat layer — so there’s a lot to think about when making a good topical formula.”

It is well worth watching the video in the above article just to see the funky haired mice.

— In a first, myself as well as all of this blog’s commentators missed the important International Society of Hair Restoration Surgery (ISHRS)’s 24th Annual Congress that ran from September 28th through October 1st in Las Vegas. I did not even see any threads on the conference in any of the hair loss forums out there, which is strange. I usually cover the 2-3 most important hair loss related conferences in the world every year in separate posts, but this time I forgot to do so. You can find the detailed ISHRS 24th Congress final program guide here. As usual, there were way too many interesting presentations. For our purposes, the most important ones were:

  • Dr. Angela Christiano: “JAK Inhibitors, Hair Regeneration and
    Genetic Testing”.
  • Dr. Pantelis Rompolas: “Potency and Contribution of Stem Cells to Hair Follicle Regeneration”.
  • Dr. Rodney Sinclair: “Advancing our Understanding of the Biology of Androgenetic Alopecia and Changing the way we use Minoxidil to Treat it”.
  • Dr. Angela Christiano and Dr. Ken Washenik led a discussion titled “Biotechnology in Hair Regeneration”.

On Twitter, Dr. Alan Bauman told me that while Dr. Christiano did not provide any data on JAK inhibitors for androgenetic alopecia (AGA), she did hint that JAK inhibitors seem to stimulate the anagen phase of the hair growth cycle. Fingers crossed as usual when it comes to this subject. I was surprised at the number of presentations on body hair transplants (BHT), with Dr. Arvind Poswal discussing long-term ten-year plus results of his BHT patients. Also surprising were the number of presentations on platelet-rich plasma (PRP).

— In stark contrast to the above omission, in the past week at least 10 (!) people either commented under a blog post or e-mailed me about cosmetics behemoth L’oréal (France) and Poietis (France) partnering to bioprint hair follicles via laser. This news item was extremely well covered across the global media and there are hundreds of articles on the internet about this interesting subject matter. The end goal “holy grail” of this research will be to implant the new hair follicles into balding regions. Here is the official company video outlining the technology and the goals behind this partnership.

— Unfortunately, it seems like Replicel has not fulfilled the contractual obligations of its partnership with Shiseido (although the former disputes this allegation). In any event, it is unlikely that this will stop Shiseido from proceeding with its plans.

— Cassiopea (Italy) updates us on its topical anti-androgen product Breezula (formerly called CB-03-01). Also see my past post on this subject. It seems like even if phase 2 and phase 3 clinical trials succeed, this product will not come to market before 2021.

— Samumed’s Dr. Osman Kibar’s presentation (a small part of it is on hair loss) at a recent conference organized by the UK’s Royal Society of Medicine. He received many compliments on Twitter for his presentation.

— Kerastem completes enrollment in Phase 2 clinical trials.

— Former baseball great Jose Canseco just announced today that he will get a hair transplant with Dr. Parsa Mohebi next week.

— Sportscaster Joe Buck’s hair transplant addiction nearly cost him his voice and his career.

— The benefits of going bald.  I would much rather have none of those benefits and keep my hair instead.

— Men’s vanity involves hair transplants.

And now on to medical items of interest:

— The National Geographic is a highly reputable magazine so I believe them when they say that ending blindness is no longer just a dream.

— Rapamycin could make your dog (and maybe humans too) live longer.

— Microsoft aims to cure cancer in ten years.  In the end it is just a programming error.

— A very interesting new endeavor: “Human Cell Atlas project aims to map the human body’s 35 trillion cells“.

— Teeth regeneration advances.

— Building a bionic spine.

— 3D printing continues to revolutionize the field of prosthetic limbs.

— First “three person baby” born in Mexico (doctors went there from the USA so as to escape strict regulations). Baby’s parents were Jordanian. Medicine will hopefully soon become very multinational.

— Stem cells regenerate damaged monkey heart.

— Yet more evidence that turmeric is very good for you, but only when added to food that is then cooked.

— Endurance training causes positive genetic changes.

— Not sure if I believe half the stuff in the below video, but it is well presented with 100 percent thumbs up likes thus far: K. Comella: “Reversing Aging with Stem Cells”: