|
PARI and Kamada
Announce Successful
Phase I Results for Aerosolized Alpha-1
Antitrypsin (AAT)
Monterey, California,
JANUARY 15, 2008 – Successful results of
Kamada’s (TASE: KMDA) Phase I clinical trial
were announced for their inhaled Alpha-1
Antitrypsin (AAT) liquid drug candidate that was
delivered by PARI’s optimized eFlow® electronic
nebulizer. Dosage levels studied resulted in
good safety profiles and patient tolerability,
leading the way to continued clinical
development of AAT for administration via an
optimized eFlow to the lungs.
The European Medicines Agency (EMEA) has already
approved Phases II-III of Kamada’s clinical plan
for treating Alpha-1 Antitrypsin deficiency with
the company's aerosolized AAT product. This
enables the company to move forward with its
joint development plan with PARI. Kamada's
aerosolized AAT is also being developed for the
treatment of other lung diseases, including
Cystic Fibrosis (CF).
“We are pleased to see these positive results in
the development of the first aerosolized AAT
therapy and look forward to the advancement of
the clinical plan,” said Dr. Martin Knoch,
President of PARI Pharma GmbH. “The advancements
with eFlow enable many active ingredients that
previously were only available through IV
therapy, such as AAT, to be delivered in a new
format via inhalation – an advancement that we
believe will truly benefit patients.”
AAT is currently used for replacement therapy in
the form of intravenous infusions that reach the
lungs through the bloodstream. Kamada also
produces and markets an intravenous AAT
preparation in several countries and is
undergoing Phase III trials in the United States
with its intravenous AAT. An inhaled treatment
would offer a targeted therapy by delivering
medication directly to the lungs.
Inhaled AAT was designated, both in Europe and
in the USA, as an orphan drug for the treatment
of Congenital Emphysema and Cystic Fibrosis
(CF).
About
eFlow
eFlow,
an electronic, portable nebulizer, enables
extremely efficient aerosolization of liquid
medications via a vibrating, perforated
membrane. Compared to other nebulizer systems,
eFlow can produce aerosols with a very high
density of active drug, a precisely defined
droplet size, and a high proportion of
respirable droplets delivered in the shortest
possible period of time. Combined with its
silent mode of operation, small size (it fits in
the palm of your hand), light weight, and
battery use, eFlow helps reduce the burden of
taking daily, inhaled treatments. For additional
information please see
www.paripharma.com
About
Kamada
Kamada
is a publicly traded biopharmaceutical company
(TASE: KMDA) developing, producing, and
marketing a line of specialty biotherapeutics
using its proprietary chromatographic
purification technologies. Licensed and marketed
in more than 15 countries, several of these
biotherapeutics hold registered and pending
patents and are currently in advanced clinical
trials. Additional information isavailable at
www.kamada.com
About
PARI Pharma
PARI Pharma develops aerosol delivery devices
and inhaled therapies. Based on PARI's 100-year
history working with aerosols, PARI Pharma
specializes in treatments for pulmonary and
nasal administration optimized to advanced
delivery platforms, such as eFlow. Focusing on
comprehensive inhalation therapy development,
including optimized nebulizer formulations,
analytics, and aerosol characterization, PARI
Pharma has several clinical development programs
ongoing, either partnered or proprietary. PARI
Pharma, a PARI Medical Holding company, is
located in Munich, Germany, with a major
presence in the United States. Online at
www.paripharma.com
Additional information is available by
contacting Kirsten Ayars at 805-452-7909 or
Geoff Hunziker at 831-372-3580.
### |