SansRosa Timeline

[Aurelia]

Hi,

I've never personally had any dealings with Dr Tony Chu but am aware that he is incredibly busy. I wonder if these regrettable delays with the RLT study are due to his being constantly over-committed? A great shame, since it sounds like such an easy study to perform. The simplest solution would perhaps be for him to let an assistant run it, but he doesn't seem to like delegating.

If he waits too long, he might well find himself getting beaten to the post by one of the many other doctors using RLT. Dr David Goldberg, M.D., J.D., has been quite vocal on the benefits of RLT, as well as writing about it, and he must be more than aware of the lack of double-blind studies into the subject.

He is a clinical professor of dermatology, as well as the director of laser research, at Mount Sinai School of Medicine in New York, which is pretty prestigious. He also has a doctorate in law, and I'm not sure but think I read that he has some university post relating to the law, so he sounds like just the kind of expert one could trust to investigate a treatment honestly and thoroughly. I wonder if anyone has suggested this to him?

Kind regards,

Aurelia

Edit: Just checked on the net and Dr Goldberg is an Adjunct Professor of Law at Fordham University School of Law in New York, where he teaches a course entitled "Advances in Health Care Law." Totally an over-achiever.

[Peter]

Well, I hate to get into an argument, as I've seen those go on WAY longer than necessary. Only to say that there has never been a single scientific study done on RLT for rosacea redness. Don't brand me a heretic just yet... RLT is probably a great treatment but I also keep hearing hype about Dr. Chu doing a study for RLT and nothing seems to materialize on that front...

In regards to Accutane, it is more for P&Ps and the redness associated with those P&Ps, not really for flushing. Plus it has some SERIOUS side effects. Clonidine, as I've read, is not officially indicated for rosacea. It helps some and for others does nothing.

What we need is a CONSISTENT, reliable medication to treat the redness, and there certainly is none right now, hence all the pain and frustration over the years. So the gentleman's statement is most certainly true.

Hello

Well I’m not arguing but just disagreeing with the statement you posted up made by Mr. Leyden. Firstly he says “appears to be” and that is obviously not definite and is non-committal. He also says currently there are no effective treatments for flushing and blushing associated with rosacea and that is not strictly true. I am all for new treatments / drugs to help rosacea sufferers but I wouldn’t want people to pin their hopes on something that may well never happen or not live up to expectations. I agree with David on this one and we shouldn’t get carried away as has happened far too often in the last couple of years.

All drugs can have side effects and some can be very minimal whilst others more serious and as we all well know with rosacea the reactions and results can also vary widely from individual to individual.

The difference between SansRosa and RLT is that the latter is readily available now, is not a drug and does not need a prescription. We have a considerable amount of anecdotal evidence that it certainly helps many people who try it and I talk from personal experience from using this form of treatment. I am not aware of any hype about the trial other than I put a post up about the proposed Hammersmith trial on the other Forum so people were aware what was in the pipeline. At the end of the day this trial may or may not confirm the effectiveness of red light with rosacea but either way it should not prevent anybody experimenting with it, if that’s what they want to do.

As Aurelia has also commented on the trial then I will reply to this separately to avoid having to repeat myself.

Thanks

Peter

[phlika29]

I'm seeing Tony in December and if Peter reminds me just before then I will ask him myself. His plan was to start it after the summer once the holiday season had finished.

[Aurelia]

Well, thank goodness that little mini-squabble was handled so politely. That's the only way we want them, thanks.

Kind regards,

Aurelia

[Peter]

Hi,

I've never personally had any dealings with Dr Tony Chu but am aware that he is incredibly busy. I wonder if these regrettable delays with the RLT study are due to his being constantly over-committed? A great shame, since it sounds like such an easy study to perform. The simplest solution would perhaps be for him to let an assistant run it, but he doesn't seem to like delegating.

If he waits too long, he might well find himself getting beaten to the post by one of the many other doctors using RLT. Dr David Goldberg, M.D., J.D., has been quite vocal on the benefits of RLT, as well as writing about it, and he must be more than aware of the lack of double-blind studies into the subject.

He is a clinical professor of dermatology, as well as the director of laser research, at Mount Sinai School of Medicine in New York, which is pretty prestigious. He also has a doctorate in law, and I'm not sure but think I read that he has some university post relating to the law, so he sounds like just the kind of expert one could trust to investigate a treatment honestly and thoroughly. I wonder if anyone has suggested this to him?

Kind regards,

Aurelia

Hello Aurelia

I share your disappointment but I have no involvement in the trial and therefore can only obtain information as and when I make contact with Tony, which is very infrequent now as I no longer see him as a patient. Having said this last week I took someone with rosacea to see him at Hammersmith Hospital and at the end of their appointment I asked him for an update on the trial. As we already know from previous information the ethics test has been resubmitted and signed off and currently he said the next step is to look at the logistics but unfortunately he has just been so busy he hasn’t had the time.

I can’t comment on his delegating skills but with all the cut backs that have take place on the NHS then maybe there isn’t anyone on his team to delegate to? I think it will happen eventually but when this will be, well your guess is as good as mine. Thanks Sarah for the offer and I’ll try and remember to remind you for your visit in December.

To be honest Aurelia I don’t really care who does the trial providing it is done properly and if you want to make contact with Dr Goldberg then feel free.

BTW I didn’t feel there was a squabble going on – just a sensible sharing of opinions which can only be healthy. People can read and decide for themselves what they feel to be correct.

Thanks

Peter

[bentherebefore]

agreed... we're on the same team vs. the R beast!

[Aurelia]

Well, that's good. No offence intended. None taken, I trust?

Kind regards,

Aurelia

[bentherebefore]

Quote:
"Dermatologists have told us MANY times that erythema remains one of the most significant unmet clinical needs in dermatology."
Colin Stewart, 11/6/07



I wanted to summarize the collagenex conference call today.

Some tidbits that were in the call about COL-118 (sansrosa)

1. The FDA was positive and excited about the drug.

2. Because there are no drugs like it to compare to, it delays things a little setting up the phase 3 trials. (there are no prior precedents...)

3. CEO mentioned that a VERY ROUGH GUESSTIMATE of a time frame for the phase 3 trial would be 12 weeks long, with followup. Also mentioned that VERY ROUGH GUESSTIMATE for the entire phase 3 program would be about a year.

4. Confirmed that the active ingredient is already FDA-approved, and again declined to reveal what the ingredient is. (although we are about 98% sure what it, at least fundamentally, is)

Quote:
"One other quick one, on the col-118, given that it's an already approved active ingredient, will that be a 505(b)(2) filing, where you'll be relying on some of the innovators information?" "Yes."



Nov. 2003 - Sansrosa founded
Feb 2004 - BioAdvance grants $250,000 for development of drug
May 2004 - Patent filed
Dec. 2004- Patent published.
July 2005 - Phase I starts at Mayo Clinic, Scottsdale
Dec. 2005 - Sansrosa acquired by Collagenex Pharmaceuticals
Aug. 2006 - Updated patent published.
Early 2007 - Phase II trials reportedly begin
Aug. 2007 - Phase II trials end and are successful
Oct. 2007 - First FDA meeting to discuss phase 3 guidelines
EARLY 2008 - Next FDA meeting to discuss phase 3 guidelines
MID 2008 - Expected Phase III start


Overall, it is severely disappointing that in this high-tech age of computers, the FDA still moves so incredibly slowly.

[David Pascoe]

Thanks for the update on the conference call. Things do indeed move slowly, but in this case surely forward.

[bentherebefore]

UPDATE:

Collagenex now has available a presentation with some additional info about COL-118. Here is a picture from the slideshow. This is the first actual photo I've seen of their phase II results. Enjoy!

Look at the difference not only in color but in the size of the face too. Interesting...