Follicum News, Completes The Phase I / Iia Study. Positive Results.

Dlogic

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News from Follicum I stumbled on. Check below.

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Follicum successfully completes the Phase I / IIa study and prepares to take FOL-005 into a Phase II clinical trial
Follicum AB ("Follicum") has now obtained the final results from the completed clinical phase I / IIa study. The results after the three-month follow-up period following completion of treatment with FOL-005 show that hair growth has returned to its original levels. The results confirm that Follicum's drug candidate FOL-005 stimulates hair growth during the treatment period.

In January 2016, Follicum initiated a clinical Phase I / IIa study at the Clinical Research Center for Hair and Skin Science ("CRC") at the Charité University Hospital in Berlin, Germany, primarily to evaluate the safety profile of the company's drug candidate FOL-005 and in Second, evaluate power parameters. In February 2017, Follicum announced that FOL-005 was well tolerated and in April 2017, FOL-005 was reported to stimulate hair growth with a statistically assured increase of approximately 8% compared to pre-treatment. The level of hair growth stimulation is similar to that described for preparations on the market.

Three-month follow-up completed
Now three months after the study participants' final treatment with FOL-005, a safety and effect follow-up has been conducted and the study as a whole is thus completed. During this follow-up period, no treatment with FOL-005 has occurred. The results show that the safety profile is very good. Approximately 2% of the growth of hair growth remains after three months without treatment, which should be compared to an increase of approximately 8% immediately after treatment with FOL-005. This confirms that Follicum's drug candidate FOL-005 is well tolerated and has a treatment effect that stimulates hair growth.

In the completed Phase I / IIa study, FOL-005 has been injected on the front of the thighs. Nevertheless, Follicum's substance has shown efficacy results that are in line with what has been published in Phase III studies for existing preparations on the market. The fact that the FOL-005 in the first clinical trial showed statistically-assured effects on hair growth, without the study being primarily designed for this, is very interesting.

Preparations for study on scalp
The next step in the development of the drug candidate FOL-005 is to carry out a study similar to the recent study but on scalp, which is the intended use of FOL-005 where the ambition is to further clarify the effect of FOL-005. In parallel, work on the development of a user-friendly formulation proceeds according to plan. When an optimized formulation has been developed, the company intends to launch a more comprehensive impact study on scalp.

CEO Jan Alenfall comments
- We are excited to report the clinical trials of the clinical phase I / IIa three-month follow-up showing that FOL-005 is well tolerated and had positive effects during the months undergoing treatment. The final results that show that only a portion of the hair-stimulating effect remained when participants did not receive our treatment were expected. The clinical study has shown that treatment with FOL-005 is safe and provides a good effect, despite the fact that we have not developed a final formulation and do not have a complete dose. Overall, these results provide a good reason for the continued development of FOL-005 in the next step of product development.
 

MomoGee

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I got to the stage where 8% increase means f*** all to me. I hope further trials shows a 200% increase :(. Nevertheless the more research and companies racing to find a solution to hair loss the better.
 

Christian Miller

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News from Follicum I stumbled on. Check below.

As a Investor in this company, what do you guys think?


Follicum successfully completes the Phase I / IIa study and prepares to take FOL-005 into a Phase II clinical trial
Follicum AB ("Follicum") has now obtained the final results from the completed clinical phase I / IIa study. The results after the three-month follow-up period following completion of treatment with FOL-005 show that hair growth has returned to its original levels. The results confirm that Follicum's drug candidate FOL-005 stimulates hair growth during the treatment period.

In January 2016, Follicum initiated a clinical Phase I / IIa study at the Clinical Research Center for Hair and Skin Science ("CRC") at the Charité University Hospital in Berlin, Germany, primarily to evaluate the safety profile of the company's drug candidate FOL-005 and in Second, evaluate power parameters. In February 2017, Follicum announced that FOL-005 was well tolerated and in April 2017, FOL-005 was reported to stimulate hair growth with a statistically assured increase of approximately 8% compared to pre-treatment. The level of hair growth stimulation is similar to that described for preparations on the market.

Three-month follow-up completed
Now three months after the study participants' final treatment with FOL-005, a safety and effect follow-up has been conducted and the study as a whole is thus completed. During this follow-up period, no treatment with FOL-005 has occurred. The results show that the safety profile is very good. Approximately 2% of the growth of hair growth remains after three months without treatment, which should be compared to an increase of approximately 8% immediately after treatment with FOL-005. This confirms that Follicum's drug candidate FOL-005 is well tolerated and has a treatment effect that stimulates hair growth.

In the completed Phase I / IIa study, FOL-005 has been injected on the front of the thighs. Nevertheless, Follicum's substance has shown efficacy results that are in line with what has been published in Phase III studies for existing preparations on the market. The fact that the FOL-005 in the first clinical trial showed statistically-assured effects on hair growth, without the study being primarily designed for this, is very interesting.

Preparations for study on scalp
The next step in the development of the drug candidate FOL-005 is to carry out a study similar to the recent study but on scalp, which is the intended use of FOL-005 where the ambition is to further clarify the effect of FOL-005. In parallel, work on the development of a user-friendly formulation proceeds according to plan. When an optimized formulation has been developed, the company intends to launch a more comprehensive impact study on scalp.

CEO Jan Alenfall comments
- We are excited to report the clinical trials of the clinical phase I / IIa three-month follow-up showing that FOL-005 is well tolerated and had positive effects during the months undergoing treatment. The final results that show that only a portion of the hair-stimulating effect remained when participants did not receive our treatment were expected. The clinical study has shown that treatment with FOL-005 is safe and provides a good effect, despite the fact that we have not developed a final formulation and do not have a complete dose. Overall, these results provide a good reason for the continued development of FOL-005 in the next step of product development.
Excellent Job.
Thank you!!!
 

MomoGee

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@MomoGee :
The results from Follicum’s phase I/IIa clinical study, which was performed on healthy volunteers, show a general stimulation of hair growth with an increase which is statistically assured at around 8% compared with growth before treatment (p=0,0038, not adjusted for multiplicity). Data from the study also show that the dose, given three times per week gives more evident effect than twice per week, which implies that a more frequent administration than was used in the study could increase the effect further.
+ it was injected in the front of the thights! Could have more impact when injected on the scalp maybe.

At least their results seems legit (even though modests). Could be something interesting to add, moreover if no side effects!
I hope it shows better results after further tweaking with dosages and using it on the scalp. Plus 8% with long-term maintenance and increased diameter of my existing hairs would put in quite a good position for a transplant.
 

Dolph

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I got to the stage where 8% increase means f*** all to me. I hope further trials shows a 200% increase :(. Nevertheless the more research and companies racing to find a solution to hair loss the better.
Agreed, but with all of these new growth stimulants that have relatively small numbers (Samumed is like 10%), we don't really know how long they stay effective. We also don't know if they will work together. Minoxidil doesn't work for a lot of people, and seems to fall off a cliff after a couple years; maybe Follicum or Samumed or one of the others has a better profile. And for people who aren't slick bald yet, maybe it gives them good enough maintenance that they can consider a hair transplant.
 

cocona

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Honestly I'll take 8%. However many treatments I need to stack to get a full head of hair idc. I'm super excited about starting stemoxydine even and that's only 4%.
 
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