FDA Grants IND for PharmaMar's ZALYPSIS(r) to Enter Phase I Clinical Trials in US
Madrid, Spain (ots/PRNewswire)
PharmaMar announced today that its Investigational New Drug application (IND)[1] has been accepted by the US Food and Drug Administration (FDA) for the clinical testing of Zalypsis(R) (PM00104/50), PharmaMar's novel marine anti-tumour agent.
Zalypsis is already in Phase I clinical development in Europe, where three multicenter studies in solid tumours or lymphoma are being carried out. The IND has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the European studies and PharmaMar intends to begin US testing of the compound in the same indications in the second quarter of 2006.
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.
"This IND is another significant milestone for the company, being the third compound in clinical development in the US", said Isabel Lozano, CEO of PharmaMar.
About Zalypsis
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.
About PharmaMar
PharmaMar is the world's leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar's clinical portfolio currently includes: YONDELIS (co-developed with Johnson & Johnson Pharmaceutical Research & Development) in Phase III clinical trials; it is designated Orphan Drug for soft tissue sarcomas and ovarian cancer by the European Commission (E.C.) and by the United States Food & Drug Administration (US FDA). Aplidin(R), in Phase II, designated Orphan Drug for acute lymphoblastic leukaemia and for multiple myeloma by the E.C. and by the FDA; Kahalalide F in Phase II, and ES-285, Zalypsis(R) and PM02734 in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
For more information, contact:
Media: Lola Casals,
PharmaMar Communication
tel.: +34-91-846-6000
Investors: Catherine Moukheibir,
Zeltia Capital Markets Operations
tel.: +34-91-444-4500This press release is also available in the News section on PharmaMar's web site: http://www.pharmamar.com/en/press/
Reference:
[1] An IND is an authorization from the FDA to administer an investigational drug or biological product to humans. Once the IND is submitted, the sponsor (usually the manufacturer or potential marketer) must wait 30 calendar days before initiating any clinical trials. During this time, the FDA has an opportunity to review the IND for safety to ensure that subjects will not be subjected to unreasonable risk.
Contact:
For more information, contact: Media: Lola Casals, PharmaMar
Communication, tel.: +34-91-846-6000. Investors: Catherine
Moukheibir, Zeltia Capital Markets Operations, tel.: +34-91-444-4500.