July 18th 2006
INDENA
AND NERVIANO MEDICAL SCIENCES AGREE TO SCALE UP NEW HIGH
POTENCY MOLECULES
Two leading Italian research centers join forces to
develop new chemicals
Milan, July 18th 2006 - Indena
S.p.A., world leader in the identification, development
and production of active principles derived from plants,
and Nerviano Medical Sciences, the largest pharmaceutical
R&D facility in Italy and one of the largest
oncology-focused, integrated discovery and development
companies in Europe, announce a co-development agreement.
Indena
has commissioned Nerviano to handle the scale up and
manufacturing of two new drug candidates for preclinical
and clinical development: IDN 5404 and IDN 5243.
With
this agreement the two companies are sharing
synergistically their main competencies, from one side
Indena has discovered two new molecules from botanical
origin and has set the original semi-synthetic path,
Nerviano, thanks to their specialization in highly potent
compound present at its API – Pharmaceutical Sciences
Business Unit, will scale up the process.
IDN
5404 is a highly potent API selected for its action
against tumor resistance to cisplatin and topotecan. IDN
5243 is a novel muscle relaxant agent for the treatment of
muscular skeletal pain.
Both
molecules are approaching Phase I after having
successfully completed preclinical.
Indena
has high hopes from this collaboration with Nerviano M.S.
with its very advanced and flexible technological platform
for the manipulation of highly potent active principles
whether as APIs or their finished dosage form.
According
to Dario Bonacorsi, Indena President and CEO, "this agreement shows how Italian companies can come together to compete
worldwide on new research projects".
"We
are proud and eager to work on concrete projects such as
the two Indena molecules; we look forward to being able to
expand the collaboration to include other highly potent
molecules, which could even be jointly developed by our
two research centers, said Giampiero
Duglio,
CEO of Nerviano Medical Sciences.
IDN
5404
A
novel thiocolchicine dimer selected for its cytotoxic
activity in nanomole range concentrations on several human
tumor cell lines and in particular on a tumor cell line
resistant to cisplatin and topotecan (Bernacki, AACR
Annual Meeting, 2005). This particular behavior was
related to a dual mechanism of action. As well as other
colchicine structure based compounds, IDN 5404 was able to
interact with microtubule dynamic and to inhibit the
activity of topoisomerase-I nuclear enzymes in a different
manner to the classical topo-I inhibitors camptothecins
(Raspaglio 2005, Biochemical Pharmacology 69:113). In
pre-clinical in vivo
testing, IDN 5404 formulated as a nanoparticle of albumin,
is active after systemic administration in human ovarian
and colon carcinomas xenograft
showing a superior efficacy than the reference
standard irinotecan (Desai, AACR annual meeting, 2005).
IDN 5404 also possesses anti-angiogenic properties as
demonstrated in the study recently reported at the last
Annual AACR Meeting by Trieu V. (97th AACR, April 2006).
The compound shows a potent action in disrupting
established microvessels and high efficacy on a human
colon tumor model superior to Combretostatin, a well known
vascular target agent.
Based
on these overall findings IDN 5404, could represent an
innovative tool in the fight against drug resistance to
conventional antitumor agents.
IDN
5243
IDN
5243 is an original NCE fruit of collaboration between
Indena and major Italian Universities, with excellent
muscle-relaxant action. The molecule showed significant
anti-inflammatory activity by intraperitoneal route at 10
mg/kg in both carrageenin induced edema and granuloma
tests. It is endowed with analgesic activity and provides
good muscle-relaxant action Toxicological studies have
been completed and the drug proved to be well tolerated.
Phase I clinical trials in healthy volunteers are
envisaged for late 2006.
Press Contacts
Cohn & Wolfe Milan
Laura Faravelli laura_faravelli@cohnwolfe.com
Lorenzo Petracco lorenzo_petracco@cohnwolfe.com
Tel.+39 02 202391
