All You Wanted To Know About Cutanix

[Guest guest]

I have read with great interest the postings concerning the company

that I current am employed by regarding the results of a clinical

study performed by us to determine the effectiveness of our lotion in

treating the symptoms associated with cea. There seems to be some

misconceptions about the company, the studies performed, and the

motives behind our launch next week. I would like to provide the

forum with details about Cutanix- the who, what, and where.

First of all, my posting here is not meant to be any type of

marketing ploy. I was contacted by one of your members this morning

via e-mail and was asked about our topical product offering set to be

launched next week. The individual was nice enough to seek me out and

write me so I wrote him back. We began a series of 10 e-mails

throughout the day that resulted in my becoming familiar with this

board. I was amazed to see how much enthusiasm (and misinformation)

had been discussed and thought I should set the record straight. I

contacted the forum moderator directly and asked if I could post to

the forum and obtained permission from him before setting out on this

post.

First of all, let me tell you about myself. My name is K.

Pilcher and I hold a Doctorate (Ph.D.) in Cell Biology and Anatomy

from the University of Oklahoma College of Medicine (1990-1994). I

spent by postdoctoral training years (1994-1998) at Washington

University in St. Louis, -Jewish Hospital in Dermatology under

Dr. Welgus (Currently Executive Director of Inflammation

Therapeutics and Anaderm for Pfizer in Ann Arbor, Michigan)studying

the role of degradative enzymes in wound healing and skin biology. I

then joined the departments of Cell Biology and Dermatology at the

University of Texas Southwestern Medical Center in Dallas, Texas.

While there, I performed contract research work for Cutanix studying

the effects of their proprietary compounds on sking aging while

continuing my main research interests on how skin responds to injury.

If interested, my research interests are still posted on their

website: http://www2.utsouthwestern.edu/gradschool/webrib/pilcher.htm

I joined Cutanix full time in August of 2002 as Director of Research

when their Research and Development Facilities were established in

Oklahoma City, Oklahoma.

Dr. Fuller is the Chief Technical Officer for Cutanix. As

stated in a previous message, he was affiliated with another startup

biotech company called MelanX that was a venture started by The

University of Oklahoma (not Illinois as stated in the previous post).

MelanX was started around Dr. Fuller's patented technology for

stimulating and inhibiting pigmentation naturally and without

ultraviolet radiation. His association with this company ended in

1996. Cutanix has since licensed Dr. Fuller's patented technology and

is currently developing novel topical formulations of natural tan

stimulators and inhibitors (skin lighteners). Dr. Fuller still

maintains his relationship with The University of Oklahoma while in

his position with Cutanix. (Side note- Cutanix licensed the Dr.

Fuller's patents from The University of Oklahoma).

Now, about Cutanix. Up until August 2001, Cutanix operated as

a " virtual company " in that they had no R&D facilities and contracted

out all of the initial basic science studies to identify novel

molecules that may have anti-inflammatory and anti-aging properties

for use in dermatologic conditions. Many start-ups typically operate

this way initially. The contract research was performed as Sponsored

Research in Dr. Fuller's lab at OUHSC and in my lab at UT

Southwestern. When we identified quadrinone it was formulated into a

cosmetically acceptable lotion and tested for in vivo efficacy in a

pilot clinical study. This study was double-blinded and placebo

controlled (as all of our studies are and have been). When the lead

compound was demonstrated to be effective in blocking UV-induced

sunburn, another round of fund raising was completed and the R&D

facilities were established in 2001. That is when I was asked to join

the company as Director of Research. Currently, the R&D staff are

made up of Dr. Fuller, Chief Technical Officer; Myself, Dr.

Pilcher, Director of Research; 4 Full-time Research Associates;

2 Part-time Research Associates; Two Graduate Students; and One

Office Manager.

Since then Cutanix has established in vitro screening methods to

identify new novel molecules for its pipeline, performed clinical

studies for rosacea and eczema, submitted three grants- two to the

Oklahoma Center for Advancement of Science and Technology and One to

the National Institutes of Health (SBIR mechanism). In addition, I

transferred my NIH grant to the company and thus, pay my own salary.

Furthermore, we have only performed three clinical studies- one each

for sunburn, rosacea, and eczema (not multiple studies as was posted

earleir). We are a small company with a small R&D budget and clinical

studies are not cheap. We have finally gotten to the point in our

lifespan that we are ready to launch. Because of our clinical results

we are excited at the potential for this lotion to help relieve the

symptoms associated with various skin conditions.

Lastly, I would like to respond to comments that are misleading and

untrue. Please understand that I am trying to respond in a calm and

cogent manner, rather than flame someone.

1.Issues of efficacy and safety. Our Dramatic Relief topical lotion

has been tested in all clinical tests in a double blinded and placebo

controlled fashion. The two page report that I have seen circulating

on the internet (and on this board) was released by our CEO,

Engles, to an individual. It was not a Press Release. In fact, our

whole marketing staff is made up of 2 consultants and our budget is

miniscule. This particular individual, Rory I believe, then posted

and disseminated the information. As such, the clinical report was

meant to speak to the layman, certainly not a peer-reviewed

scientific piece. The results speak for themselves- the only issue I

have seen was regarding the method of the study. I assure you that

this is the only cea study we have done and we are reporting all

of the results. Again, it was double blinded and placebo controlled-

that information was simply not included in the original document

sent to Rory. Safety- I have had a number of individuals ask me what

the ingredients of the topical formulation are. I will post those

tomorrow when I get back into the office. Our active ingredient-

called Quadrinone- is currently undergoing patent protection, so for

obvious reasons I cannot tell you what it is exactly. I can tell you,

however, that it is a naturally occuring molecule that is on the FDA

GRAS list (generally recognized as safe). We have performed a number

of our own toxicologic tests on the lotion (active included)

formulation using an independent preclinical testing company and it

is non-irritating and non-sensitizing.

2. Published studies. With all due respect to Dr. Lazoff, Medical

Society journals are not the only " Top Medical Journals " . The Journal

of Investigative Dermatology is the premier research journal for the

Society of Investigative Dermatology. The other top society in the

Dermatology field in America is the American Academy of Dermatology

(where we will pressent in 2003). The JID is peer reviewed and

considered by derms in the field to be " the " journal for dermatologic

basic science research. Incidentally, Dr. Zoe Draelos, the

Dermatologist who has performed all of our clinical studies is a past

President of the American Academy of Dermatology.

The phrase " plan to be published " refers to the fact that we are

currently writing the manuscripts. A typical method of publishing

one's results (whether they be academic or industry) is to first

present them in poster form at a National Conference. We presented

the cea results at the SID conference that was held in Los

Angeles last week. We are now in the process of writing the papers

and they will be submitted for peer revies shortly. I understand the

skepticism demonstrated by members of the forum regarding our

clinical results. Yes, we performed them with a clinical

dermatologist and not by an independent university center. Simply

put, our R&D budget could not afford the studies discussed.

Again, All Three Studies We Have Done Have Been Double Blinded and

Placebo Controlled. I only described the rosacea study because that

is the one I was asked about.

3. Ulterior motives. I responded to because I was pleased he

had even heard of us! I assure you that there is no ulterior

marketing machine at work. All in all, Cutanix R&D is made up of 10

full time employees with a few consultants filling in important areas

(HR, marketing, etc). Two- the CEO and Administator are in Santa

Clara and the rest of us are in Oklahoma City, Oklahoma at the R&D

facility. We are living up to our full mission statement as I wrote

it to -

" Cutanix's mission is to perform rigorous cell and molecular biology

> on our proprietary active molecules, formulate them in cosmetically

> acceptable lotions (non-irritating and non-comedogenic), assess how

> much is driven into the skin using Franz cell analysis, and perform

> rigorous clinical studies to test efficacy in vivo. Our clinical

> work is double-blinded and placebo controlled "

I sent the free sample to simply because he asked for it to

try. I personally don't have a marketing director telling me what to

do- we don't have one! I just thought it a good will gesture.

4. Website. We realize that our website is very rudimentary. I

believe I saw the word " pathetic " used in a previous post and you'll

get no argument here. We are frantically working on getting an

elegant website up and running to replace the current version and it

should be up within a couple of weeks. It will be a work in progress

so please be patient!

In sum, Cutanix is hoping for a product that works. Why would we want

to sell anything short of something cosmetically elegant that

improves your symptoms? It would be company suicide to do anything

different.

Respectfully,

K. Pilcher, Ph.D.

Director of Research

Cutanix Corporation