Madrid, Spain (ots/PRNewswire)
- PharmaMar announced today that
its Investigational New Drug application (IND) 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
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
"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.
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.
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,
Investors: Catherine Moukheibir,
Zeltia Capital Markets Operations
This press release is also available in the News section on
PharmaMar's web site: http://www.pharmamar.com/en/press/
 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
ots Originaltext: Zeltia Group
Im Internet recherchierbar: http://www.presseportal.ch
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.