Clinical Data
FNS - Definition
FNS is a topically applied formula designed to treat hair loss.
FNS - The Concept
The idea for FNS for treating alopecia was conceived during the
development of a treatment for chronic wounds. The rationale for
this concept, proven reasonable, was to bypass the circulatory
insufficiency that exists in and around the wound. This formula
creates an optimal microenvironment and supplies the cells in the
wound with the required means for growth. Indeed, within a
relatively short period, the treatment resulted in complete healing
of the wounds which previously failed to respond to months and even
years of conventional treatments. An interesting phenomenon was
observed during the treatment, the hair follicles around the wound
were stimulated to synthesize the proteins needed for growth of new
hair. The next step, i.e., testing the effects of formula on scalp
hair growth was self-evident.
FNS - Composition
FNS is composed of three major components:
- Non-steroidal anabolic hormone
- Cell culture medium
- Vehicle
These components and their role in stimulation, supply, and
support contribute to the overall beneficial effects of FNS.
This in-situ tissue culture technology is implemented, with minor
adaptations, into other medical applications.
Hair Growth - General
The process of hair growth involved many types of cells forming
tissues which are organized into an organ called the hair follicle.
The scalp hair growth cycle involves three phases. The growth phase
associated with the active follicle (anagen) is followed by the
regressive phase in which the follicle ceases to synthesize the
keratin (catagen) and finally the hair falls off (telogen).
At any time, about 90% of the scalp hair is in the anagen phase.
Anagen lasts for about two years during which the hair shaft
continues to elongate. In a normal cycle, the regressive phase lasts
about three months and thereafter the hair follicles re-enter the
anagen phase of growth. However, in the process of balding an
increased number of hair follicles revert to the regressive phase
resulting in enhancement of hair loss. It is known that the cycle is
affected by factors such as hormones, chemicals, emotions, etc. The
most common type of balding is Androgenetic Alopecia (Male Pattern
Baldness) that affects both men and women.
FNS - The Effect
The hypothesis was that FNS will activate the follicle to return
to the anagen phase resulting in cessation of hair loss and
induction of hair regrowth. The effects of the FNS components were
tested on a number of experimental systems.
The following experiments indicate direct evidence of FNS action
on hair:
- A six-month, double blind, randomized, vehicle controlled
study on young men suffering from androgenetic alopecia.
Cessation of hair loss within three weeks was reported by most
of the participants which was corroborated by a significant
increase in hair counts of the treated group compared to the
vehicle treated group. These findings were supported by an
overall increase in subjective satisfaction with the treatment
and by objective global evaluation of the FNS treated group.
- In-vivo human hair organ culture. Growth at optimal rate of
0.3 mm/day for 10 days in the presence of FNS (without vehicle).
In addition, restored pigmentation of hair was observed.
The following experiments provide indirect support for FNS
biological activity.
- Laser Doppler circulation measurements. Burn wounds treated
with the tissue culture technology expressed increased
circulation.
- In-vivo cells proliferation. The in-situ tissue culture
technology was found effective in accelerating wound healing.
Although each of the components had some effects, the
combination was significantly more effective. The process of
wound healing involved the formation of vascular granulation
tissue and keratinocytes proliferation.
- Extended cell viability. Adipocytes viability in culture
medium was maintained for three weeks compared to one week of
the control.
To summarize:
FNS stimulates viable regressive follicles to re-enter the anagen
phase as well as supporting the hair growth. It supplies nutrition
to the cells in a direct mode and via induction of increased
circulation and neovascularization. No side effects were reported or
observed.
FNS - Why
Currently there are two main products that obtained FDA approval
for marketing as a drug for treating alopecia. The first is
Minoxidil marketed under the name Rogaine™ which was originally
used for treating high blood pressure by induction of peripheral
vasodilation; its daily application also produced side effects of
growing new hair. It is now sold OTC (over the counter) but it has
many side-effects.
The second product is marketed under the name Propecia™ and it
is allowed for use only on men. This product also produces side
effects and therefore its use is limited.
FNS - The Source
FNS is one more product developed in the tissue regeneration unit
at the Technion's school of medicine. The laboratory, headed by
Prof. Ella Lindenbaum, a holder of a number of international
patents, is involved in applied medical research and dedicated to
the idea of developing medical commercial products.
An important aspect of the work in the laboratory is the
continuous collaboration with colleagues in the clinical departments
of the Faculty affiliated hospitals.
In addition, Prof. Lindenbaum is a scientific consultant to
several incubator start up biotechnology companies and a consultant
to Osmotics Corp.
