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PharmaMar's Fifth Novel Compound, Zalypsis(R), Enters Clinical Development

Madrid, Spain (ots/PRNewswire)

PharmaMar announced today that
Zalypsis(R) (PM00104/50), its fifth new marine derived compound, has
begun Phase I clinical trials, already in patients, for the treatment
of solid tumours.
Zalypsis is a novel chemical entity related to the marine natural
compounds Jorumycin and the family of Renieramycins, obtained from
molluscs and sponges, respectively. Zalypsis binds to DNA and is
cytotoxic; however, it does not activate the "DNA damage checkpoint"
response. Thus, Zalypsis has cytotoxic effects dependent on DNA
binding that are not associated with DNA damage.
In pre-clinical trials, Zalypsis demonstrated strong in vitro and
in vivo antitumoural activity in a wide variety of solid and
haematological tumour cell lines and human transplantable breast,
gastric, prostate and renal xenografted tumours. Zalypsis also
demonstrated a manageable and reversible preclinical toxicology
profile.
The new Phase I clinical trial is a standard dose escalating,
prospective, open-label, non-randomised, multicentre study designed
to determine the safety, tolerability, maximum tolerated dose and
recommended dose of Zalypsis, which will be administered as a 1-hour
intravenous infusion every 3 weeks to patients with advanced solid
tumours or lymphoma.
Dr Carmen Cuevas, PharmaMar's R&D Director, said: "In line with
the strategy announced at our Business Review day last January, we
have now added a fifth compound to our clinical portfolio. Zalypsis
has shown remarkable activity in preclinical studies and we have high
hopes for its clinical development. This molecule has excellent
chemical and pharmacological properties, which highlight the value of
marine-derived medicines for cancer therapy."
About PharmaMar
PharmaMar is the world leader biopharmaceutical company in
advancing cancer care through the discovery and development of
innovative marine-derived medicines. PharmaMar's clinical portfolio
currently includes Yondelis(TM) in Phase II clinical trials
(co-developed with Johnson &  Johnson Pharmaceutical Research &
Development), designated Orphan Drug for  STS by the European
Commission (E.C.) in 2001 and by the FDA in 2004, and  Orphan Drug
for ovarian cancer by the E.C. in 2003; Aplidin(R), in Phase II,
designated Orphan Drug for acute lymphoblastic leukaemia by the E.C.
in 2003  and by the FDA in 2004, and for multiple myeloma by the FDA
and the E.C. in  2004; Kahalalide F in Phase II and ES-285 and
Zalypsis(R) in Phase I  clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the
Zeltia Group (Spanish stock exchange:
Yondelis(TM) is the trademark of trabectedin (formerly ET-743),
and Aplidin(R) and Zalypsis(R) are registered trademarks of
plitidepsin (formerly APLD) and PM00104/50 respectively, all of them
of PharmaMar.

Contact:

Lola Casals, Communication Manager, PharmaMar, Tel: + 34-91-846-6000,
David Yates & Deborah Scott, Financial Dynamics, Tel: +
44-(0)20-7831-3113

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