Cellmid Limited has received strong positive results in all measured areas of its independently conducted, randomized, blinded and placebo controlled human clinical study of the évolis ONE formulation. The 32 patient study was conducted with Cellmid’s novel and proprietary FGF5 inhibitor formulation, évolis ONE, which is a fully optimised, GMP manufactured and market ready product.
Using Gravimetric Analysis1 évolis ONE has shown a statistically significant 80.2% reduction in hair loss over 112 days (16 weeks) with twice daily use. Hair differentiation (or anagen/telogen ratio, a measure of growing versus resting hair follicles) improved with an increase of 44.2% in growing follicles during the same period, as analysed by the Van Scott “hair pluck” method2. Hair release and recovery (overall improvement in hair quality and volume) was quantified by PhotoGrammetrix™3 measurements and has shown an improvement by a statistically significant 143.3%.
The trial was conducted by AMA Laboratories, INC. in New York, a leading independent CRO specialising in dermatological product testing. The efficacy study followed a 51 subject Repeat Insult Patch Test (RIPT) to assess safety by evaluating skin irritation and sensitisation. The safety study, also conducted by AMA Laboratories, resulted in a “zero adverse event” report.
“In addition to the hair count and hair loss measurements the photographs taken during the PhotoGrammetrix™ evaluation demonstrate visible improvement in overall hair quality and volume” added Maria Halasz, CEO of Cellmid. “As this product has active ingredients subject to Cellmid’s recently filed patent application, the results give us multiple opportunities to commercialise this valuable asset” she added.
“These are very exciting and valuable results expected to support stronger clinical hair growth claims of this proprietary product” said Darren Jones, Head of Product Development at Cellmid. “FGF5 is well recognised as the ultimate controller of hair loss. We are excited to be the first on the market with a clinically validated product range addressing FGF5″ he added.
Cellmid, on behalf of its wholly owned subsidiary Advangen Limited, contracted independent CRO, AMA Laboratories, to conduct a 16 week clinical study in September 2014 to evaluate the efficacy of its novel FGF5 inhibitor formulation, which is subject to patent applications. The key objectives of the clinical study included quantitative assessment of hair loss, hair release and recovery and hair differentiation.
Efficacy of évolis ONE was measured by Gravimetric Determination, Van Scott “Hair Pluck” method and using PhotoGrammetrix™ scientifically matched photography. Visual evaluation was conducted by AMA’s Institutional Review Board.
Individuals included in the study experienced “patterned baldness” of 2 to 4 on the Hamilton-Norwood scale (men) and I-2 to II-2 on the Ludwig scale (women) of hair loss. Study participants were otherwise in general good health and within the healthy weight range, aged 31 to 55 years.
FGF5 and its inhibitors
FGF5 is well recognised as the ultimate regulator of hair cycle and hair length in humans4. Expressed by macrophage-like cells surrounding the hair follicle, it acts by triggering the dermal papilla to transition from growing (anagen) to resting (telogen) phase. Overexpression of FGF5 induces hair follicles to undergo premature entry into catagen phase and fall out.
Several groups have been pursuing FGF5 inhibition as a strategy to prevent hair loss and increase hair growth. Cellmid, through its wholly owned subsidiary Advangen Limited, is the first company with a clinically validated FGF5 inhibitor hair growth product on the market.
(1) A trained technician combed each subject’s hair 20 times employing a standardised technique to capture the “fall-off”. Recovery aggregates were weighed to establish hair loss reduction patterns if any.
(2) Not less than 10 hair shafts were excised from the targeted region of the scalp and categorised as anagen or telogen. Ratios were calculated according to Van Scott.
(3) Photographs taken by PhotoGrammetrix™ equipment allow for the area affected by alopecia to be captured and quantified.
(4) Higgins, et al. 2014. “FGF5 is a crucial regulator of hair length in humans” PNAS, 11(29):10648-53
Source: Cellmid Limited