An evaluation of the effects
on ProZ92 on proliferation of skin cells in culture
By J. Gibson, Ph.D., FACMG
Molecular/cellular biologist
Psoriasis is a condition characterized by hyperplasia (escalated
cell growth rate) of the epidermal keratinocytes of skin causing
flaky scales which are a hallmark of this disease. Skin is
composed of an underlying dermis comprised of fibroblast cells
covered by an epidermal layer composed of keratinocyte cells.
It is not clear if fibroblasts play a role in facilitating the
increased level of keratinocyte growth, therefore experiments
were performed in our laboratory to study the effects of Z92 on
the growth characteristics of both cell types. Z92 was added
intact and void of acetic acid to pure populations of
fibroblasts and keratinocytes.
Twenty-eight 28 data points for each treatment were collected
and evaluated using statistical methods to compare cell growth
rates.
Data indicate that intact Z92 and fraction 1 ( Z92 void acetic
acid) both significantly inhibited the growth of kertinocytes,
but nether had any effect on fibroblasts. These preliminary
laboratory studies and histological evaluation of skin treated
with Z92 in a mouse model of psoriasis indicate that the
compound inhibits the growth of keratinocytes and that this
activity is specific for this cell type.
ProZ92 evaluation in a
Murine model of psoriasis
By Dr. F. Kennedy
Psoriasis is an oftentimes devastating chronic recurrent
papulosquamous dermatitis without an effective cure.
Z92 has been developed for the treatment of psoriasis.
In a preliminary controlled study, Z92 has been applied
topically on flaky skin
(fsn/fsn) mice, which are an experimental model for psoriasis.
Z92 induced dramatic gross and microscopic changes similar to
those of a chemical
burn only on the hyperproliferative skin of flaky mice with
minimal to no effects on
control mice also treated once a week for up to seven weeks.
The treated necrotic skin remains attached firmly as a
biological bandage for up to
six weeks on flaky mice allowing healing of the underlying skin.
The reasons that this product specifically affects only affected
skin so dramatically
have not yet been fully determined but alteration in the keratinocytes and barrier
function of the epidermis and its basement membrane are suspected to be responsible.
This product may normalize the regulation of keratinocyte
proliferation
in psoriatic lesions as well.
This hypothesis is supported by in vitro tritiated thymidine
uptake study finding that
Z92 significantly reduced growth and division of epidermal
keratinocytes but not dermal
fibroblasts from normal and keloid tissues.
Clinical study results
Previous experience treating
humans in with ProZ92 has been obtained in approximately 200
patients in Israel. All had previous treatments of various
natures.
The results from
these treatments consisted of symptomatic relief from itching,
flaking and irritation.
None of the patients were
receiving any oral or topical medications at the time of the
ProZ92 treatments.
Treatment with ProZ92 continued
until the lesions and symptoms disappeared.
The treatment periods ranged
from two to 18 weeks.
Follow-ups after treatment
ranged from seven months to three years and showed resolution of
the psoriasis with no visible recurrences.
Here is a summary of the
clinical trail conducted in compliance
with the protocol, cGCP, applicable regulatory requirements:
- The extensive report
includes over 300 pages and is 18 megabytes in
size.
- It was delivered to us in
July, 2005 dated June, 2005.
- The trials were a success.
- The study concludes that
68 percent of patients experienced an improvement of 1 or
more on the Physician’s Global Assessment (PGA).
- 43 percent of users
saw a Physician’s Global Assessment (PGA) reduction of 2 or
more.
- 17 percent saw a
reduction of 3 or more.
- 67 percent of patents
who started with a PGA of 4 (the most severe in the patient
population) experienced an improvement of 2 or more.
- 89 percent of
patients who started with a PGA of 4 (the most severe)
experienced an improvement of 1 or more on a scale of 5
in the PGA.
- 91 percent of the
patents started the study with a condition classified as
“deteriorating.”
- 100 percent of the
patients tested experienced no side effects while using
ProZ92.
- Based on this, data it is
believed that if the medication protocol treatment period was
longer, the results would have been even better.
The clinical trials on ProZ92
were conducted under the following:
- FDA authorization #58983
- Canadian Natural health
product authorization #101392
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