|
PARI and Kamada Announce Positive
Intermediate Phase I Results for Inhaled Alpha-1
Antitrypsin
MONTEREY, CALIFORNIA, MAY 31, 2007 – The first
of two stages of the Phase I clinical trial show
positive results for Kamada’s Alpha-1
Antitrypsin (AAT) liquid drug candidate for
inhalation delivered with PARI’s eFlow
electronic nebulizer for the treatment of
patients suffering from AAT deficiency. Dosage
levels studied resulted in good safety profiles
and patient tolerability, leading the way to
continued drug development of aerosolized AAT
delivered with an optimized eFlow.
The study, which was approved by the European
Medicines Agency, involved 24 patients who
received various doses of inhaled AAT. AAT, also
known as Alpha-1 Proteinase Inhibitor (API), is
used for chronic replacement therapy in
individuals who lack AAT and have an inherited
form of panacinar emphysema.
Lack of AAT leads to various health problems
including significant reduction in lung
function, lung inflammation, shortness of
breath, and recurrent exacerbations. This leads
to emphysema, which is marked by damage to the
walls of the air sacs in the lungs resulting in
inefficient breathing and shortness of breath.
“In November 2006, we signed a strategic
agreement with Kamada to develop inhaled AAT
using our advanced aerosol delivery platform,
eFlow. Today, we are pleased that this
collaboration is showing good initial results
and are optimistic that this partnership will
benefit patients in the long term,” said Dr.
Martin Knoch, President of PARI Pharma GmbH. “By
developing a targeted therapy that can be
administered directly to the lungs, we believe
this could be a substantial improvement and a
great example of how the advancements in eFlow
are helping to improve drug delivery to the
lungs in the future.”
AAT is currently used for replacement therapy in
the form of weekly intravenous infusions that
distribute the medication throughout the
bloodstream in order to reach the lungs. An
inhaled treatment would offer a more targeted
therapy by delivering medication directly to the
lungs. Kamada is developing inhaled AAT in
partnership with PARI. Kamada also produces and
markets an intravenous AAT in several countries
and is undergoing Phase III trials in the United
States with its intravenous AAT.
Inhaled AAT was designated, both in Europe and
in the USA, as an orphan drug for the treatment
of congenital emphysema and cystic fibrosis.
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 biopharmaceutical company engaged in
development, production, and marketing of high
quality, ready to use, plasma therapeutics.
Kamada, Ltd. is based at Kiryat Weizmann Science
Park, Ness Ziona, Israel. Online at
www.kamada.com
About PARI Pharma
PARI Pharma focuses on the development of
aerosol delivery devices and therapies. Based on
PARI’s 100-year history working with aerosols,
PARI Pharma develops treatments for pulmonary
and nasal administration optimized to advanced
delivery platforms, such as eFlow.
PARI Pharma provides comprehensive inhalation
drug development, including nebulizer
formulation development and optimization, CMC,
analytics, aerosol characterization, clinical
protocol development, and regulatory guidance.
PARI Pharma has several clinical development
programs ongoing, either partnered or on its
own. 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. |