LATEST NEWS

6/22/2021

MILESTONE PUBLICATION

On January 18, 2021 the MCW NF1 Cutaneous PDT Phase I Clinical results were published in Photobiomodulation, Photomedicine, and Laser Surgery – Volume 39, Number 6, 2021.  The peer reviewed publication traces the evolution of the PDT (Photodynamic Therapy) of Cutaneous NF1 study – starting with a vision, through cell studies, mouse studies, to now the 2nd phase of human clinical studies.  This procedure is noninvasive; there are no other treatments except surgery for cutaneous neurofibromas.

Levulan Kerastick is an FDA approved PDT dermatological treatment for keratosis.  In the NF1 study, it is applied topically to the neurofibromas.  It is absorbed into cutaneous AND/OR sub-cutaneous neurofibromas.  As it is absorbed, it converts to a light sensitive form PpIX.  When irradiated with “red light”, PpIX creates free-radical oxygen that kills neighboring cells.  The procedure works for both surface and subcutaneous neurofibromas, and is entirely NONINVASIVE.

Results of the now completed, Phase I Cutaneous NF1 Clinical trial shows THAT LEVULAN PDT SELECTIVELY KILLS NF CELLS WHILE COMPLETELY SPARING NORMAL CELLS!  A VERY SIGNIFICANT FINDING! 

—–CLICK HERE TO VIEW FULL PUBLICATION-—-

SIGNIFICANT ADVANCEMENTS 

Not hard to imagine the difficulty in accurately locating, measuring, and tracking cutaneous neurofibromas.  The challenge is being assured that the same neurofibroma is being analyzed after months or years lapse, and with collateral changes in configuration.  There are no clear bench marks.  Think growing children, neurofibroma surface changes and growth, irregular boundaries, and the invisible 3rd dimension (iceberg beneath the surface).

FOTOFINDER – As to accurate location and tracking of neurofibromas – a special FotoFinder camera was purchased.  The high-resolution camera captures the total body, and identifies each of the lesions.  The image records the relative position and shape of each lesion.

VEVOMD HIGH-FREQUENCY ULTRASOUND – The VevoMD by Fuji Film is an ultrasound imager that is able to record the below-surface configuration of each neurofibroma.  Thus the full volume of each neurofibroma can be assessed for that moment in time.

Together these advancements enable an infinitely more accurate tracking and documentation of changes or lack thereof, of the neurofibroma shape, size, and volume. 

PHASE II CLINICAL TRIALS 

Phase II is a double-blind study comparing PDT using Levulan Kerastick and a placebo (just the vehicle).  The goal is to assess the progression, and change in size of the neurofibromas.  For the neurofibromas that continue to grow, the assessment metric is time to 50% increase in lesion size.

One of the NF1 Team’s visions is to treat incipient neurofibromas and hopefully nip their growth before they become readily visible.  Thus, avoiding the psychosocial pain of visible disfigurement.  This will be a wonderful outcome should it come to pass!

The Phase II adult studies are ongoing.  Invitations are open for additional patient volunteers.

Hi Everyone 🙂   My name is Marsha Malloy and I’m the current research nurse coordinator for this study.  The clinical trial is currently open to  patients living in the USA,  with a clinical diagnosis of NF1 ,  age 14-30 with at least  cutaneous NFs on trunk  OR one of their arms/legs. Mileage reimbursement is provided.  Study details can be found on this Ben’s NOW  website and also at https://www.clinicaltrials.gov/ct2/show/NCT02728388?term=Whelan&rank=2

IF you are interested in participating in the study or have questions, reach out to  me directly at 414-955-0704 or mmalloy@mcw.edu.  I look forward to  hearing from you 🙂