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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."
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.
ots Originaltext: PharmaMar
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Lola Casals, Communication Manager, PharmaMar, Tel: + 34-91-846-6000,
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