Re: All You Wanted To Know About Cutanix

[Guest guest]

I appreciate your posting here, Dr. Pilcher, and for personally

addressing the issues I raised. I'm sure you realize that not all the

issues you addressed were from me; for example, I'd never stoop so

low as to call your Web site " pathetic. "

Speaking for myself, I hope you're aware my comments reflect

heightened skepticism regarding any study funded and designed by a

company. Unfortunately (from my perspective as a physician), such

studies are becoming increasingly common, and in general I don't

believe they represent a convincing pool of data.

Here's the problem I still see: even as a private communication to a

layperson, the study said absolutely nothing about a control cream or

control subjects (and it's not easy to imagine where these would fit

in); it described Dr. Draelos as assessing the scores herself; and

the scale as described sounds imperfect as a tool for assessing

rosacea, much less for assessing changes in an objective manner.

I recognize these criticisms are directed at an unofficial

presentation of the data. Still, I presume it was an accurate

description. You must agree that, as presented to us, it is not

accurate to describe Dr. Draelos' study as blinded and controlled.

Not that we need to over-glorify those qualities -- many terrible

studies are double-blinded and placebo-controlled and published in

top medical journals (one example that comes to mind: the company's

zinc study for treatment of the common cold, published last year in

JAMA or NEJM).

Results arising from biased methodology also " speak for themselves. "

Marketing need not take place within a specific department -- every

person associated with a company markets their product, but that's

understandable. I'm very glad that my initial concerns proved

unwarranted in this case (but I'm not discouraged from questioning

sources of posted information in the future).

Thank you too for clarifying the relationship between Dr. Fuller and

Cutanix. Sadly (again, from my perspective), academic and commercial

interests are becoming one, what with so many start-up companies

arising out of academia. But I suspect you disagree.

I know you cannot reveal much about Quadrinone, but I'm intrigued

that it is a naturally occuring molecule already on the FDA's

GRAS list, and a sunblock besides. Sounds like zinc oxide.

Seriously, can you share with us whether the 1% solution is a

sunblock or sunscreen, whether it protects against both UVA and UVB,

and if the latter, it's spf?

I remain skeptical of company-sponsored conference presentations and

studies, no matter how well-credentialled the researcher may be. I

know why most physician-researchers participate in these types of

studies.

But my skepticism is balanced by the real need for good products and

services, for myself and for my patients. I know that corporate

interests can synch with public need, especially for common, chronic

conditions like rosacea. And I also know that time will tell whether

Cutanix's products are as effective and safe as you claim. I hope so.

My rosacean skin could certainly use a safe, effective anti-

inflammatory product.

Marjorie

Marjorie Lazoff, MD

> 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