NYU College of Dentistry’s Bluestone Center for Clinical Research
is one of four sites — and the only dental school — to participate
in a Phase I study involving oral manifestations of a dermatological
disorder. The other sites participating in the study are Johns Hopkins
School of Medicine, Case Western Reserve School of Medicine, and
the University of California at San Francisco (UCSF) School of Medicine.
The new study will assess an investigational drug therapy for Pemphigus
Vulgaris, a dermatological disorder, which causes burn-like lesions
or blisters to develop on the skin and mucous membranes, including
in the mouth. NYU will enroll one-fifth of the trial’s subjects.
The two-year trial is sponsored by biotechnology developer Peptimmune,
Classified as a rare disorder by the FDA, Pemphigus Vulgaris causes
the body to produce an immune response to a specific portion of
desmoglein 3, a protein found in normal healthy skin and oral mucosa.
This results in painful eruptions on the face and neck or in the
mouth, which, if left untreated, can lead to disfigurement and even
“Most Pemphigus Vulgaris patients experience oral lesions,” says
Dr. Jonathan Ship, Director of the Bluestone Center for Clinical
Research, and a coinvestigator in the trial.
“One of the advantages of this project is that we’ve been able
to overcome traditional obstacles to dentist- physician collaboration,
thanks to having a research facility designed specifically for studies
involving both medical and oral health components. The Bluestone
Center enables physician-dentist involvement in both the development
and implementation of a research protocol,” said Dr. Ship.
The Pemphigus trial evaluates the safety of PI0824, a tolerizing
peptide that is intended to desensitize the immune system by targeting
and disabling defective T cells before they can start an abnormal
immune reaction against healthy skin and oral mucosal cells. The
treatment has the potential to relieve symptoms without the serious
side effects associated with corticosteroids and immunosuppressants,
which are commonly prescribed for Pemphigus treatment. Subjects
in the Peptimunne study continue to receive daily corticosteroid
Dermatologic medications are commonly used off-label to treat some
two dozen oral mucosal conditions, such as chronic canker sores
(aphthous stomatitis) and lesions caused by candida (fungal) infections,
Dr. Ship said. But drug-makers have been reluctant to sponsor research
to support applications for oral indications in part because of
a shortage of clinical research facilities that can efficiently
carry out studies requiring oversight by both dentists and dermatologists.
He noted that the Pemphigus trial involves systemic drug administration
via infusion requiring close medical supervision throughout the
day, as well as dermatology and oral medicine expertise in assessing
Pemphigus- associated lesions. The Bluestone Center’s research nurses
are using US Holter’s new digital ECG continuous monitoring system
for this study.