Subantimicrobial doxycycline treat,ment (Periostat)

[Guest guest]

NEWTOWN, Pa.--(BUSINESS WIRE)--June 17, 2002-- CollaGenex

Pharmaceuticals, Inc. (Nasdaq:CGPI - News) today announced that it

has initiated a multi-center, double-blinded, placebo-controlled

clinical study to evaluate the efficacy of its product, Periostat®,

for the treatment of meibomianitis, also known as ocular rosacea and

characterized by symptoms of " dry eye " .

There is currently no FDA-approved systemic treatment for

meibomianitis.

The study, which will enroll 70 patients, is being conducted by

Holland, M.D., Professor of Clinical Ophthalmology at the

University of Cincinnati and Director of Cornea Service at the

Cincinnati Eye Institute, Lane, M.D., Clinical Professor of

Cornea and External Diseases at the University of Minnesota and

Refractive Surgeon at Associated Eye Care located in Stillwater, MN,

and Janine Tabas, M.D., Associate Clinical Professor at the Wills Eye

Hospital, Philadelphia, PA and Cataract and Refractive Surgeon at Kay

& Tabas Ophthalmology Associates in Bala Cynwyd, PA.

" Meibomianitis is a chronic inflammatory disease, with no cure, " said

Dr. Holland. " The primary mode of treatment is to administer

doxycycline at doses of 100 to 200 mg per day, along with daily

eyelid hygiene, for long periods of time. This treatment regimen

often leads to significant side effects, primarily nausea and

diarrhea, and also increases the risk of developing microbial

resistance. Anecdotal evidence suggests that Periostat, a 20-mg

formulation of doxycycline, may be equally effective in treating

meibomianitis without the side effects of high dosage antibiotics. "

" The potential to treat meibomianitis with Periostat is based on our

knowledge and in-depth understanding of certain mechanisms of action

occurring in inflammatory diseases, as well as numerous anecdotal

reports from current patients that their dry eye symptoms improved

while taking Periostat for periodontitis, " said M. Gallagher,

PhD, chairman, president and chief executive officer of

CollaGenex. " Periostat, the first FDA-approved and commercialized

product from our IMPACs technology, has demonstrated the ability to

inhibit a number of destructive proteases and cytokines involved in

inflammatory processes. We look forward to obtaining the results of

this trial, and the potential to offer a novel treatment for patients

suffering from this disease. "

Meibomianitis is the most frequent diagnosis made by

ophthalmologists, affecting more than 15 million people in the United

States. The disease is characterized by a chronic inflammation and

dysfunction of the meibomian glands, which are located on the eyelids

and produce the lipids that comprise the surface layer of tears.

Meibomian gland dysfunction often leads to alterations in the

composition of tears, causing patients to experience pain, ocular

redness, light sensitivity, dry eye and decreased visual acuity.

Symptoms can be ameliorated through the application of artificial

tears and other topical applications, although there currently is no

FDA-approved systemic medication for meibomianitis.

CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical

company currently focused on providing innovative medical therapies

to the dental and dermatology markets.

http://biz.yahoo.com/bw/020617/172571_1.html

Also see The Dermatology Times :

Doxycycline hyclate reduces comedones by 50 percent.

Author/s: Beth A. Kapes

Issue: Nov, 2001

Newtown, Pa. -- The subtherapeutic dosage of doxycycline hyclate

tablets (Dermostat), 20 mg, is a valuable therapy against moderate

acne while maintaining a somewhat independent stature from its

antimicrobial affects, according to a multicenter clinical trial.

Doxycycline hyclate did reveal statistically significant benefits

against each of the pre-established primary endpoints, including

reducing total inflammatory lesions and total lesion counts. Most

surprisingly, doxycyline hyclate appears to reduce the total number

of comedones by 50 percent, the study's chair, Skidmore, M.D.,

chief of dermatology, University of Florida Medical Center, said.

Dentists who regularly prescribe a 20-mg dose of Periostat for its

anti-inflammatory role against periodontal disease reported their

theory that doxycycline hyclate may also be effective against adult

acne. With this hypothesis, the drug's manufacturer CollaGenex

Pharmaceuticals, embarked on the placebo-controlled, double-blinded,

six-month, 50 patient clinical trial to evaluate Doxycycline's

efficacy in treating moderate acne. Rodney Kovach, M.D., chief of

dermatology, West Virginia University Health Sciences Center, also

conducted the study.

" While I was initially skeptical of the drug effectively addressing

each of the endpoints -- especially the anticipated goal of reducing

overall comedones -- we did find this pilot study to show Dermostat's

effectiveness on all levels, " Dr. Skidmore said. " There were very few

side effects, in addition to showing an absence of photosensitivity --

a side effect seen in many acne therapies. "

Dr. Skidmore said the study clearly illustrates the potential

clinical benefit of Dermostat in the management of inflammatory acne,

while showing no bacterial resistance in its submicrobial dosage.

The most compelling evidence that the long-term, low-dose therapy may

be beneficial for the treatment of acne was presented in the data

analysis confirming no evidence of an antimicrobial effect, changes

in resistance profiles on the skin flora, or cross-resistance to

other antibiotics when compared with placebo.

While discussions with the FDA for approval of doxycycline hyclate

tablets as Dermostat are planned for this fall, and patent

applications have been filed with the U.S. Patent and Trademark

Office, Dr. Skidmore contended that patients with moderate acne could

gain benefit from the drug now.

" Periostat was approved by the FDA in 1998, and it could currently be

used for its anti-inflammatory benefits with excellent results, " Dr.

Skidmore said. " Dermatologists should see from this study that

Dermostat appears to be a relatively innocuous therapy that can be

administered long-term with potentially few side effects. "

Source:

http://www.findarticles.com/cf_1/m0UMR/11_22/81477926/p1/article.jhtml

?term=dermostat

I hope this help.

o

[Guest guest]

Thanks, Quechuchu. Not surprising that CollaGenex is looking to

increase revenues by looking for new on-label indications. A good

study should help answer the concern that Periostat may be too low a

dose to be effective for the majority of rosaceans.

From a medical perspective, it would be much more helpful to see the

difference in efficacy, safety, and cost between the present long

term therapy -- doxycyline, 50 mg a day, or every other day -- and

Periostat's doxycycline, 20 mg a day. The FDA just requires that

Periostat is more effective than a placebo, not necessarily the most

medically effective or cost-effective drug on the market. But I

wonder if the difference between a 20 mg and a 50 mg dose is enough

to justify the difference in cost.

Marjorie

Marjorie Lazoff, MD

> NEWTOWN, Pa.--(BUSINESS WIRE)--June 17, 2002-- CollaGenex

> Pharmaceuticals, Inc. (Nasdaq:CGPI - News) today announced that it

> has initiated a multi-center, double-blinded, placebo-controlled

> clinical study to evaluate the efficacy of its product, Periostat®,

> for the treatment of meibomianitis, also known as ocular rosacea

and

> characterized by symptoms of " dry eye " .

>

> There is currently no FDA-approved systemic treatment for

> meibomianitis.

>

> The study, which will enroll 70 patients, is being conducted by

> Holland, M.D., Professor of Clinical Ophthalmology at the

> University of Cincinnati and Director of Cornea Service at the

> Cincinnati Eye Institute, Lane, M.D., Clinical Professor of

> Cornea and External Diseases at the University of Minnesota and

> Refractive Surgeon at Associated Eye Care located in Stillwater,

MN,

> and Janine Tabas, M.D., Associate Clinical Professor at the Wills

Eye

> Hospital, Philadelphia, PA and Cataract and Refractive Surgeon at

Kay

> & Tabas Ophthalmology Associates in Bala Cynwyd, PA.

>

> " Meibomianitis is a chronic inflammatory disease, with no cure, "

said

> Dr. Holland. " The primary mode of treatment is to administer

> doxycycline at doses of 100 to 200 mg per day, along with daily

> eyelid hygiene, for long periods of time. This treatment regimen

> often leads to significant side effects, primarily nausea and

> diarrhea, and also increases the risk of developing microbial

> resistance. Anecdotal evidence suggests that Periostat, a 20-mg

> formulation of doxycycline, may be equally effective in treating

> meibomianitis without the side effects of high dosage antibiotics. "

>

> " The potential to treat meibomianitis with Periostat is based on

our

> knowledge and in-depth understanding of certain mechanisms of

action

> occurring in inflammatory diseases, as well as numerous anecdotal

> reports from current patients that their dry eye symptoms improved

> while taking Periostat for periodontitis, " said M. Gallagher,

> PhD, chairman, president and chief executive officer of

> CollaGenex. " Periostat, the first FDA-approved and commercialized

> product from our IMPACs technology, has demonstrated the ability to

> inhibit a number of destructive proteases and cytokines involved in

> inflammatory processes. We look forward to obtaining the results of

> this trial, and the potential to offer a novel treatment for

patients

> suffering from this disease. "

>

> Meibomianitis is the most frequent diagnosis made by

> ophthalmologists, affecting more than 15 million people in the

United

> States. The disease is characterized by a chronic inflammation and

> dysfunction of the meibomian glands, which are located on the

eyelids

> and produce the lipids that comprise the surface layer of tears.

> Meibomian gland dysfunction often leads to alterations in the

> composition of tears, causing patients to experience pain, ocular

> redness, light sensitivity, dry eye and decreased visual acuity.

>

> Symptoms can be ameliorated through the application of artificial

> tears and other topical applications, although there currently is

no

> FDA-approved systemic medication for meibomianitis.

>

> CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical

> company currently focused on providing innovative medical therapies

> to the dental and dermatology markets.

>

> http://biz.yahoo.com/bw/020617/172571_1.html

>

> Also see The Dermatology Times :

> Doxycycline hyclate reduces comedones by 50 percent.

>

> Author/s: Beth A. Kapes

> Issue: Nov, 2001

>

> Newtown, Pa. -- The subtherapeutic dosage of doxycycline hyclate

> tablets (Dermostat), 20 mg, is a valuable therapy against moderate

> acne while maintaining a somewhat independent stature from its

> antimicrobial affects, according to a multicenter clinical trial.

>

> Doxycycline hyclate did reveal statistically significant benefits

> against each of the pre-established primary endpoints, including

> reducing total inflammatory lesions and total lesion counts. Most

> surprisingly, doxycyline hyclate appears to reduce the total number

> of comedones by 50 percent, the study's chair, Skidmore,

M.D.,

> chief of dermatology, University of Florida Medical Center, said.

>

> Dentists who regularly prescribe a 20-mg dose of Periostat for its

> anti-inflammatory role against periodontal disease reported their

> theory that doxycycline hyclate may also be effective against adult

> acne. With this hypothesis, the drug's manufacturer CollaGenex

> Pharmaceuticals, embarked on the placebo-controlled, double-

blinded,

> six-month, 50 patient clinical trial to evaluate Doxycycline's

> efficacy in treating moderate acne. Rodney Kovach, M.D., chief of

> dermatology, West Virginia University Health Sciences Center, also

> conducted the study.

>

> " While I was initially skeptical of the drug effectively addressing

> each of the endpoints -- especially the anticipated goal of

reducing

> overall comedones -- we did find this pilot study to show

Dermostat's

> effectiveness on all levels, " Dr. Skidmore said. " There were very

few

> side effects, in addition to showing an absence of

photosensitivity --

> a side effect seen in many acne therapies. "

>

> Dr. Skidmore said the study clearly illustrates the potential

> clinical benefit of Dermostat in the management of inflammatory

acne,

> while showing no bacterial resistance in its submicrobial dosage.

>

> The most compelling evidence that the long-term, low-dose therapy

may

> be beneficial for the treatment of acne was presented in the data

> analysis confirming no evidence of an antimicrobial effect, changes

> in resistance profiles on the skin flora, or cross-resistance to

> other antibiotics when compared with placebo.

>

> While discussions with the FDA for approval of doxycycline hyclate

> tablets as Dermostat are planned for this fall, and patent

> applications have been filed with the U.S. Patent and Trademark

> Office, Dr. Skidmore contended that patients with moderate acne

could

> gain benefit from the drug now.

>

> " Periostat was approved by the FDA in 1998, and it could currently

be

> used for its anti-inflammatory benefits with excellent results, "

Dr.

> Skidmore said. " Dermatologists should see from this study that

> Dermostat appears to be a relatively innocuous therapy that can be

> administered long-term with potentially few side effects. "

>

> Source:

>

http://www.findarticles.com/cf_1/m0UMR/11_22/81477926/p1/article.jhtml

> ?term=dermostat

>

>

> I hope this help.

>

> o