SAN DIEGO, July 7 /PRNewswire/ -- Genetronics Biomedical Ltd. today announced
it has successfully completed animal efficacy and human tolerance testing for
its unique, proprietary transdermal drug delivery (TDD) method to deliver a
vasodilating drug, such as prostaglandin, into the penis to treat erectile
dysfunction.
Genetronics has developed a needleless TDD device which uses
electroincorporation, a variation of electroporation, to deliver the drug into
the penis. Electroporation is a well-known scientific technique, which uses
pulsed electric fields to induce temporary new pores, or channels, in cells
and tissues. This allows a therapeutic drug or beneficial gene to enter
through the otherwise impermeable cell membrane.
The TDD device includes battery-powered, disposable, flexible electrodes,
which conform to the shape of the penis, and provide a pulsed electric field
to the surface of the penile skin, inducing transient pathways into the
underlying tissue. This allows access of a vasodilator drug, enhancing the
penile blood flow required for erections.
Animal tests in a pilot study at Boston University School of Medicine under
Irwin Goldstein, M.D., who is considered one of the world's principal
impotency experts, showed that Genetronics' TDD device induced full erections
in four of seven rabbits tested, and a partial erection in the other three.
Rabbits are a well-accepted animal model for testing drugs used in erectile
dysfunction.
Human testing of the TDD device in a Phase I device trial with 20 volunteers
demonstrated that Genetronics' TDD device was well-tolerated and had no
unexpected side effects. Men noticed an instantaneous "tingling" sensation
when the pulse was delivered, which was tolerated at electric fields even
above the therapeutic range.
Based on these encouraging results, Genetronics believes it can commence a
Phase I drug trial with its delivery method. Genetronics is seeking a
corporate partner for its novel erectile dysfunction technology.
"We believe we can improve upon invasive medical techniques, such as needle
injection, and, because our system delivers the drug locally, we believe we
can avoid side effects which occur with systemic delivery," said Dr. Dietmar
Rabussay, Vice President, Research and Development. "This treatment can be
used as an alternative treatment in patients who cannot respond to or tolerate
existing therapies."
All the recent publicity surrounding the approval and marketing of the oral
erectile dysfunction pill Viagra(R) has caused a significant increase in the
awareness of this condition, according to Rabussay.
"This is another example of the flexibility of the drug delivery platform
technology that Genetronics has developed," said Lois Crandell, Genetronics
CEO and President. "We believe that Genetronics' technology will enable the
more efficient delivery of numerous therapeutic drugs and beneficial genes."
"Genetronics' major efforts continue to be in oncology, with emphasis on
delivering a potent anti-cancer drug directly into tumor cells," Crandell
said. She said the majority of the Company's budget goes toward
commercializing Genetronics' Electroporation Therapy for cancer.
"We have, however, developed a delivery method that lends itself to numerous
therapeutic applications and one of these is in the potential $10 billion
erectile dysfunction market," Crandell said. "If, upon approval, we were to
attain sales for three percent of the erectile dysfunction market, this could
bring in $300 million per year."
Erectile dysfunction is the consistent ability to achieve or maintain an
erection sufficient for satisfactory sexual activity. That means not just an
occasional problem, but one that has been occurring repeatedly for a period of
time. It is a widespread condition, shared by approximately 30 million men in
the U.S. The majority of erectile dysfunction cases are associated with
physical conditions or events, including some that are age-related. The most
common risk factors include diabetes, high blood pressure, hardening of the
arteries, high cholesterol, spinal cord injury, multiple sclerosis,
depression, stroke, or surgery for the prostate or colon. It is estimated that
between 30 to 50 percent of the 8 million diabetic men in the U.S. suffer
erectile dysfunction.
Founded in 1983, Genetronics is headquartered in San Diego and is recognized
worldwide as the technology leader in the field of electroporation. It has
been working since 1991 to devise ways to use electroporation to improve
treatment of catastrophic illnesses, including cancer and heart disease, and
to improve quality of life in patients with other conditions such as erectile
dysfunction, hemophilia and skin aging.
Visit Genetronics Website at http://www.genetronics.com
This press release may contain certain forward-looking statements. Actual
events or results may differ from the Company's expectations. There can be no
assurance that any product in Genetronics product pipeline will be
successfully developed or manufactured, or that final results of human pilot
studies or clinical studies will be supportive of regulatory approvals
required to market products. The Toronto Stock Exchange has not reviewed and
does not accept responsibility for the adequacy or accuracy of this release.
SOURCE Genetronics Biomedical Ltd.
CO: Genetronics Biomedical Ltd.
ST: California
IN: MTC
SU: PDT
07/07/98 09:23 EDT http://www.prnewswire.com