Novagali Pharma launches Phase I clinical trial in oncology for its oral
formulation of paclitaxel

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.

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"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc

thanks yet again for the research Curtis