Farrel says,
"Jack Clifford is Procyte's President and CEO and is here
to tell us more about their new product called GraftCyte as
well as to update us on the Trichomin testing. So I will turn
the floor over to our special guest tonight Mr Jack Clifford"
Jack Clifford says, "First of all please hold
questions until the end of my introductory statement. We're
pleased to have this opportunity to present our technology
and current product focus, and to respond to your questions.
As you may know, ProCyte was established over 10 years ago,
by Dr. Loren Pickart and a group of businessmen. Dr. Pickart's
early work in peptide-copper research was instrumental in
giving ProCyte its initial scientific platform. ProCyte's
scientists have significantly expanded that knowledge base
as the company identified new compounds, formulations, doses
and clinical utility of a family of copper peptide compounds.
It is important to note that differences in dose, formulation
and peptide structure have been clinically shown to substantially
alter the intended effect of a compound.
One fairly recent development is the compound we call PC1358,
also tradenamed Tricomin solution. PC1358 is a second generation
compound that ProCyte developed and has tested for treatment
of androgenetic alopecia (AGA). While it is a peptide that
chelates copper, it is not the same compound as that found
in Iamin or GraftCyte - both of which are wound care products.
We recently announced positive results of a Phase II study
of PC1358 in 36 subjects with early to midstage AGA. At present,
we are evaluating future development plans for this compound.
On
a separate product focus from our compounds that actively
promote hair growth, ProCyte has been studying the use of
its compounds and products for wound care. We have a new product
that we believe have a positive effect on outcomes in hair
transplant surgical procedures. GraftCyte Moist Dressings
will be promoted to the physician for use post-transplant.
The GraftCyte Dressings contain a copper peptide compound
in a new formulation. The dressings are first applied by the
physician immediately upon completion of the transplant. Each
dressing provides a copper peptide-enriched moist environment,
that has been shown to help the transplant area repair faster
than historical controls. Following the initial application
at the time of surgery, the patient will take the remaining
dressings home and follow physician instructions for keeping
the transplant area moist and protected.
We hope to follow up these two wound care products with additional
products that augment the body's natural wound repair processes.
We will keep you advised of future products through our web
page at www.procyte.com.
I'd be happy to respond to your questions about these products
or the Company in general.
B1stman: "Can you give further details about the
phase 2 results just released...they seemed somewhat spotty
to some of us."
Jack Clifford says, "The hair count data was promising."
Ginko: "When will we see Trichomin on the market?"
Jack Clifford says, "We are seeking to license
Tricomin to a consumer products company. It will depend on
their plans."
Bardo: "Why was the trial stage over such a limited
time, and a limited number of participants."
Jack Clifford says, "Because it was an early phase
2 study. We were looking for confirmation of the effect we
saw in an earlier study. Typically phase 3 studies are extended
beyond phase 2 studies in length and number of participants."
B1stman: "But there was no additive weight??
Jack Clifford says, "That is correct."
Bradley: "How close is Procyte to striking a deal
with a cosmetic firm for tricomin?"
Jack Clifford says, "We are in discussions and
cannot comment further at this time."
B1stman: "Any explanation for the deteriorating
stock price and when we might see some improvement??
Jack Clifford says, "All biotechnology companies
are down. It's always hard to understand why the market does
or doesn't react in a certain way."
Look: "Will tricomin be a prescription drug?"
Jack Clifford says, "Depends on the licensors
development strategy."
Maximus: "How does tricomin work ?"
Jack Clifford says, "Research has shown that the
copper peptide technology modulates the body's natural biological
processes."
Maximus: "How long would it take to achieve good
results ?"
Jack
Clifford says, "In the phase 2, positive outcomes
were seen after 24 weeks of treatment."
B1stman: "Have you procured patent protection
for tricomin yet??
Jack Clifford says, "Yes."
Bradley: "What differentiates tricomin from Folligen?"
Jack Clifford says, "Tricomin is a patented copper
peptide technology, Folligen is not."
Ginko: "Do you think that Piliel from Life Medical
Sciences will be any competition for Trichomin?"
Jack Clifford says, "We don't know at this time.
We have not seen their data."
Willard: "In what form is tricomin to be delivered
to the scalp?"
Jack Clifford says, "It is in a topical solution."
Look: "Has Iamin been shown to promote hair growth?
Is Iamin gel "stronger" or "weaker" than
tricomin?"
Jack Clifford says, "Iamin is a different copper
peptide than tricomin. We have never clinically tested Iamin
for hair growth."
Ginko: "Do you think that GraftCyte has regrowth
potential"
Jack Clifford says, "GraftCyte is used following
hair transplant surgery. GraftCyte enables the body's natural
healing process to occur."
B1stman: "Any ideas on what the cost of Trichomin
will be"
Jack Clifford says, "Not at the present time."
Bardo: "But why wouldn't you use say 300 men in
the studies, over 6 months to see if the product did indeed
work, since you wouldn't want to waste time and effort on
a product that didn't work?
Jack Clifford says, "Because it would take much
longer than 6 months to enroll the subjects and conduct the
study."
Bardo: "How do you select participants in your
clinical studies?"
Jack Clifford says, "They are screened by the
clinical investigator."
Bardo: "What are current and future treatments
for hair loss."
Jack Clifford says, "At present there is only
approved hair loss treatment that can make hair loss claims,
that is minoxidil. The future is looking hopeful with recent
clinical results from Merck and others, including us."
B1stman: "When will the company become profitable??"
Jack Clifford says, "The company is just introducing
it's new products in 1997 and expect continual roll out in
1998. I can not comment on profit."
Maximus: "How does Trichomin work, and what does
it modulate in the body biological processes ?
Jack Clifford says, "Primarily through follicle
protein synthesis and activation of the hair cycle. We believe
these are due to the copper delivery from the peptide."
Maximus: "What are your views about propecia ?"
Jack Clifford says, "Interesting science."
Maximus: "Are Graftcyte and Tricomin different
names for the same product ?"
Jack Clifford says, "No. They contain different
copper peptide compounds."
Bardo: "What side effect have potential to arise,
or did you see in the trials of Trichomin?"
Jack Clifford says, "We have seen none."
B1stman: "When will phase 3 trials start and be
completed in your estimation...and how will u enroll people
Jack Clifford says, "We are still evaluating future
plans for this compound. No study is presently planned or
in progress."
Look: "Tricomin looks promising. As an investor,
when could I reasonably expect Tricomin to start boosting
sales?"
Jack Clifford says, "It depends on finding a partner
for tricomin. GraftCyte will be available for sale shortly."
Ttown: "How long will it be before your products
are put in shampoos and conditioners and marketed as health
and beauty aids instead of a drug."
Jack Clifford says, "We are currently developing
new products in these areas."
B1stman: "So tricomin is way off from coming to
market??
Jack Clifford says, "Again it depends on finding
a partner and our own internal product development. We may
introduce other copper peptide technologies in these new products."
Bardo: "If it works as you state, why wouldn't
you rush this to the market?"
Jack Clifford says, "The development costs can
be very significant for a drug, there are faster options we
are considering."
Bardo: "Jack-What can you tell us of your future
plans"
Jack Clifford says, "We are attending hair transplant
medical seminars to introduce GraftCyte."
B1stman: "Why do u feel u need a partner for tricomin
but not your other products??
Jack
Clifford says, "The cost of drug development is lengthy
and costly."
Maximus: "Do u believe if propecia became approved,
that tricomin will be killed by the competition ?
Jack Clifford says, "We believe that that there
are markets for a number of effective products. Some individuals
may chose to treat their hair loss in different ways."
Bardo: "What are some of the options your previously
mentioned for moving Tricomin forward?"
Jack Clifford says, "In addition to a partner
for a drug application, there are many other cosmetic alternatives."
Look: "why not just bring Tricomin to market as
a non-prescription drug like Iamin Gel. Is this possible?
Are you considering it?
Jack Clifford says, "Yes, non-drug options are
being considered."
Ttown: "In your clinical phase 2 testing it was
stated that there was no significant hair weight increase
with Tricomin. If it is so promising how come it didn't produce
increased hair weight."
Jack Clifford says, "The process of regrowing
hair is a long term proposition. We believe that an increase
in hair counts will, in time, lead to an increase in hair
weight."
Johnson: " Are there any known side effects when
taking tricomin?"
Jack Clifford says, "none."
Willard: " What makes Tricomin either a "drug"
or a "cosmetic" - strength?"
Jack Clifford says, "The label claims and how
they are supported by clinical data."
Ttown: "How long before the other products you
mentioned are available."
Jack Clifford says, "GraftCyte products will be
available in May. The others shortly thereafter."
Ginko: "What are your thoughts on Dercap / Aminexil
from L' Oreal ?"
Jack Clifford says, "We know very little of this
product."
Farrel says, "What is the strength difference
in the Gel and Gauze GraftCyte products"
Jack Clifford says, "We don't comment on proprietary
formulations."
Ginko: "What is the difference in your Iamin Gel
and Protect and Restore from SBI?"
Jack Clifford says, "The Iamin contains our copper
peptide technology which has been clinically tested and FDA
cleared."
Farrel says, "Tell us more about the benefits
of using the GraftCyte Product after a transplant."
Jack Clifford says, "GraftCyte can help you achieve
you hair transplant goals in a shorter time by keeping the
sites moist and supplied with essential nutrients."
Farrel says, "Will it prevent the transplanted
hairs from initially falling out."
Jack Clifford says, "We have not observed that
effect in every case."
Ttown: "W hat do you think about nioxin as compared
to your product tricomin."
Jack Clifford says, "What is nioxin? "
Farrel says, "I believe its a product sold in
salons, but I think you've answered the question :)"
Johnson: "Where can I purchase Iamin, at a local
pharmacy or only though mail order?"
Jack Clifford says, "Iamin Hydrating Gel is available
through distributors and some pharmacies. Customer service
is available at our web site. www.procyte.com."
Ginko: "What are your thoughts on Viviscal from
Finland?"
Jack Clifford says, "We have no thoughts on this."
Farrel says, "If a person was having a transplant
would there be any benefit to using Iamin as well as Graftcyte"
Jack Clifford says, "Iamin gel is not the correct
product for transplant sites. It would be useful to use Iamin
Gel on the donor site. The gel is formulated to serve as a
barrier and an essential aspect of hair restoration success
is that the surgical area be kept moist for a period post-surgery."
Ginko: "Can a person fill out a application to
be involved in a study?"
Jack Clifford says, "No. The proper procedure
for study participation is recruitment by the clinical investigator."
Farrel says, "Ok thank you Jack for coming and
informing us it was very interesting and we enjoyed having
you as a guest."
Johnson: " Thank you for your time Mr. Clifford,
it's been a very informative hour."
Jack Clifford says, "Thank you Farrel."
Farrel
says, "Great well thanks to all who attended and
thanks again to Jack and ProCyte"
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