This proprietary oral micro-emulsifying paclitaxel dosage form, developed
by Novagali's in-house R&D team, paves the way for a new approach in the
treatment of several types of cancer
Evry, France, May 31 2005 - Novagali Pharma, a biopharmaceutical
company developing innovative drug delivery systems
principally in ophthalmology and oncology, announced
today the launch of a Phase I clinical trial in patients
with advanced cancer for its oral formulation of
paclitaxel. The study is being conducted at the Netherlands
Kancer Institute, Amsterdam, in order to assess patient
tolerance and pharmacokinetic properties in patients
with cancer.
Paclitaxel is active against a broad range of cancers
but generally has to be used in intravenous form
and administered once every three weeks. Novagali
Pharma has designed a new oral formulation which
improves the treatment, limits patient discomfort
and eliminates the need for staying at the hospital.
The company has developed a self-micro-emulsifying
oily formulation which allows oral administration
of the chemotherapy while maintaining efficacy and
safety of use.
"Starting clinical trials for a product which enables
oral administration of paclitaxel and other taxanes
offers a major opportunity to explore new ways of
treating cancer," says Jérôme Martinez,
President and CEO of Novagali Pharma. "The preclinical
results have been extremely promising and we are
eager to get the first Phase I results, which we
expect before the end of the summer."
"The availability of an oral formulation of paclitaxel
with a good tolerance profile is a major therapeutic
breakthrough for ambulatory treatment of patients
with cancer," explains Dr. Florence Binlich, VP development
and medical affairs for Novagali. "It will also allow
combination with other oral chemotherapies and should
enable the prevention of long-term relapse. Paclitaxel
belongs to the taxane class of major chemotherapy
agents. They have been used for many years in intravenous
forms for the treatment of breast and ovarian cancer
or non-small cell lung carcinoma (NSCLC)."
About Novagali Pharma: http://www.novagali.com
Novagali Pharma, Evry, near Paris, develops innovative
drug delivery technologies focused on ophthalmology
and oncology. Created in 2000, Novagali already
has a number of products in Phase I and II clinical
trials. These include ophthalmic emulsions to
treat dry eye syndrome and orally administered
anti-cancer drugs. Since its creation, Novagali
Pharma has raised close to EUR18 million from
investors including 1.2.3. Multinova, Auriga Partners, CDC Entreprises Innovation,
Fonds de co-investissement J.E., Rothschild Investment Partners, Siparex
Ventures et Tech Invest.
The technology is based on cationic emulsions. The originality of this approach
lies in creating emulsion droplets with positive charges on their surface
(whereas these droplets usually have negative charges). Thanks to this, the
positive emulsion droplets are attracted to all biological membranes as the
latter are negatively charged. Novagali's nano-emulsion droplets are about
150 nanometers in size and allow the formulation of a wide range of molecules
while enhancing their absorption and effectiveness. This technology platform
can be applied in many delivery applications, including ocular, oral, injectable
and dermatological, and also across a variety of therapeutic areas.
Heidi Thompson
ANDREW LLOYD & ASSOCIATES
http://www.ala.com
heidi@ala.com
Brighton Business Centre 95 Ditchling Road Brighton
BN 1 4ST ENGLAND
Tel : +44 1273 675100 Fax : +44 1273 675400
55 rue Boissonade 75014 PARIS FRANCE
Tel : +33 1 56 54 07 00 Fax : +33 1 56 54 07 01
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