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 NANOTECHNOLOGY (Continued)

Nanotechnology has the potential to revolutionize the practice of
medicine, particularly as it relates to the delivery of drugs.  
Innovative nanotechnology based systems are raising the
possibility of drug delivery across the impenetrable skin barrier.  
Small size and the ability to deliver drugs effectively once
penetration is achieved are critical for success of this approach.  
One way to get drugs through the skin barrier is to enclose
molecules in particles called liposomes.  Liposomes are artificial
membranes in a spherical shape, that can fuse with cell
membranes.  The drug inside the liposome is then delivered into a
cell.  

A Brazilian physician has applied for a U.S. Patent to use a
nanotechnology based drug delivery system to treat Peyronies
Disease (PD) and other connective tissue disorders.  His invention
refers to a process, notably supra molecular
(supra - above &
beyond)
nano particles in the therapy of PD.  His active ingredients
will consist of papin
(protein splitting enzyme from the juice of the
unripened papaya), bromelain (plant extract digestive enzyme
from the pineapple) and ficain (enzyme from figs).
 These are
vegetable proteolytic
(aids in breaking down and assimilating
proteins)
enzymes which will be encapsulated in liposomes and
applied as an ointment.

According to the patent application, this inventor physician has
successfully used his nanotechnology ointment for treating PD
and a number of additional connective tissue disorders.  This
ointment facilitates the destruction of foreign bodies and
hydrolyzes the collagen.  (This is the same process that Xiaflex’s
manufacturer alleges will improve the curvature).  The patent
application reports the following successful applications of the
ointment:

  • A small group of men with penile fibrosis and curvature were
    treated with this ointment.  It was applied daily for 30 minutes
    for a period of 8 to 12 months.  The ointment was applied in
    the penile dorsal and lateral regions.  It was reported that sixty
    percent of men had a full recovery of the wound, 20% had
    partial recovery and 20% no recovery.  

  • (Hypertrophic scar) In 4 cases, two daily applications of the
    ointment for 60 days resulted in a 50% improvement with
    reduction of the scar height and softening of the scar.

  • Dupuytren's Contracture.  Gel was applied two times daily
    with a resulting significant improvement after 40 days.

I wrote to this physician requesting further information about the
results.  He responded that he could not ship his ointment to the
United States.  If I were willing to travel to Brazil, he would supply
me with the ointment for my personal use.

These preliminary results are encouraging, but there are plenty of
reasons for caution.  I had difficulty following the study results
noted in the patent application.  They were incomplete and leave
many questions unanswered.

The doctor refers to wound healing and fully recovery of
Peyronies Disease patients.  What exactly does this mean?  There
is no mention of curvature measurements or penile functioning.

The application reported that 24 men between the ages of 41 and
72 were analyzed in 63 cases. What does this mean, were some
men counted more than once? Most importantly, I was unable to
determine if any of the findings published were peer-reviewed.

There is mention of a study of 40 adult rats divided into a control
and treated group.  The treated group received the ointment for
their wound.  I could not locate further details about the wound or
outcomes.

Nanotechnology is an exciting field which will ultimately result in
many innovative treatments for previously incurable disorders.  
This nanotechnology approach to PD appears to offer the
possibility of a convenient, non-toxic treatment.  However, the
inventor of this approach is going to have to do a better job of
presenting the results of his ointment before it will even begin to
move forward towards a commercially available treatment.