Hey everybody, welcome to another edition of Weekly Thoughts. This week I touch on two topicals that have been at the forefront of the attention of hair growth enthusiasts this past year. Also, I take a look at an intriguing healthcare legislation that was just passed in the United States this week.
Remember when Kelopesia burst onto the scene earlier this year? Man, that was a hoot. It was slated as a new stem cell-conditioned media cream which would be available by the end of April in Turkey. Well, turns out that was not the way it happened. We’re not quite sure what lead to the delay, but that’s not really important anymore. What’s important is that we are actually close to the re-scheduled release date of Kelopesia. This past week I decided it was a good time to get an update from Yeditepe University.
Prof. Fikrettin Sahin, the gentleman and scholar who developed the Kelopesia cream, told me this week that his team is “working hard” to get Kelopesia released to the Turkish market in Spring 2017 and “hopefully” it will be released in January. There you have it.
Yes, he does mention that the release will be for the “Turkish” market. What does that mean for the rest of the world? It does mean that it will take more time for the product to be officially released in the rest of the world. However, it does not mean that the cream will be impossible to get if you do not live in Turkey. You can always visit Turkey or find other options on the internet.
Brotzu Lotion Trialing
It is only right that if we got news about Kelopesia we should hear more about the other top-notch topical making waves in the hairternet. I heard from a representative at Fidia Pharma that the famed Brotzu Lotion is still undergoing a clinical trial with the company and therefore a release date is not certain yet.
My own personal take is that things should be winding up in the trial soon. The lotion seems to have been in a clinical trial for a good amount of time now; the trial was reported to begin last March. Personally, I have a good feeling about it, I do feel that this product is going to be released by Fidia at some point. For now, the release date is unknown.
America Accelerates Cures
This past week US President Barack Obama signed the 21st Cures Act into law. The bill is referred to as “Cures” and is heralded to advance the discovery, development, and delivery of drugs and therapies in the US market. It will do this by providing major funding to the National Institute of Health over the next several years, modernizing clinical trials, and utilizing health records and patient data in new ways to promote research collaboration. If you do a little internet research on the subject you will find some differing opinions on the impact of Cures among the healthcare industry, but whose really got time for that?
Readers of this blog pretty much want to know one thing — how does Cures affect hair growth treatment development? The answer is no one really knows yet. Experts in the regenerative medicine industry are still reviewing this huge piece of legislation to understand it better. Also, the way the bill is written leaves room for variables in how the FDA will actually utilize Cures.
Here’s what we do know about Cures for now:
- Regerative medicine products, including stem cell therapies, can be granted “accelerated approval” by the FDA
- Accelerated approval does allow a treatment to be available to patients before completing a phase III trial
- Accelerated approval is typically intended for medical conditions with unmet needs
The questions of whether hair growth treatments will be allowed to utilize accelerated approval and exactly how all of this will work are unanswered at this point. To be honest though, it’s really nothing to lose sleep over. Treatments will go through the process anyways, if Cures provides some expediency to that, then very good. We’ve got to keep pushing forward, regardless. Time will tell how the FDA intends to utilize the new provisions of the 21st Century Cures Act. I recommend these three articles for more background: STAT, Wired, and TheHill. If there are any scientists or industry persons reading this that can offer some insight on the Cures Act please comment below.
It has been a good year everybody and unless something major pops up in the next two weeks, I’ll speak to you all in 2017. Have a Happy New Year 🙂