PharmaMar Initiates a Phase III Registration Trial with Aplidin(R) in Multiple Myeloma Patients
By Pharmamar, PRNEMonday, June 7, 2010
MADRID, June 8, 2010 - PharmaMar SA (Grupo Zeltia, ZEL.MC) today announced that a registration
trial in relapsed/refractory multiple myeloma patients has been initiated
with Aplidin(R) (plitidepsin) in combination with dexamethasone versus
dexamethasone alone.
This pivotal, international, multicenter Phase III clinical trial, called
ADMYRE, will enrol 300 patients in 60 medical centers across 20 countries
(including the U.S., Europe, Asia and South America), with an estimated
recruitment period of 24 months. The primary objective of ADMYRE is
Progression Free Survival (PFS).
Aplidin(R) is an anti-tumor agent originally isolated from the
Mediterranean tunicate Aplidium albicans and currently obtained by chemical
synthesis. Aplidin(R) is the second most advanced compound in clinical
development at PharmaMar.
About PharmaMar
PharmaMar is Grupo Zeltia's biotechnology subsidiary; it is a world
leader in discovering, developing and selling marine-based drugs to treat
cancer. Yondelis(R) is Spain's first anti-cancer drug. It is currently
approved for soft tissue sarcoma (STS) in 25 countries outside the EEA, and
in 5 of those countries for platinum-sensitive recurrent ovarian cancer (ROC)
as well. Yondelis(R) is approved for STS and platinum-sensitive ROC in all 30
countries of the EEA; in Switzerland it is approved for STS. Phase II
clinical trials with Yondelis(R) are also under way on prostate, breast, lung
and paediatric cancers. PharmaMar has four other compounds in clinical
development: Aplidin(R), Irvalec(R), Zalypsis(R) and PM01183. PharmaMar also
has a rich pipeline of pre-clinical candidates and a major R&D programme.
About Zeltia
Zeltia S.A. is a world-leading biopharmaceutical company specialised in
the development of marine-based drugs for use in oncology and central nervous
system illnesses. Grupo Zeltia consists mainly of the following companies:
PharmaMar, the world-leading biotechnology company in advancing cancer care
through the discovery and development of innovative marine-derived medicines;
Noscira, a biotech firm focused on discovering and developing new drugs
against Alzheimer's disease and other neurodegenerative central nervous
system diseases; Genómica, Spain's leading molecular diagnostics company;
Sylentis, dedicated to researching therapeutic applications of gene silencing
(RNAi); and a chemical division comprising Zelnova and Xylazel, two highly
profitable companies that are leaders in their respective market segments.
Important note: PharmaMar, which is headquartered in Madrid (Spain), is a
subsidiary of Grupo Zeltia (Spanish stock exchange: ZEL), which has been
listed on the Spanish Stock Exchange since 1963 and on Spain's Electronic
Market since 1998. This document is a press release, not a prospectus. This
document does not constitute or form part of an offering or invitation to
sell or a solicitation to purchase, offer or subscribe shares of the company.
Moreover, no reliance should be placed upon this document for any investment
decision or contract and it does not constitute a recommendation of any type
with regard to the shares of the company.
For more information (Tel. +34-91-444-4500) Media Relations Fernando Mugarza Capital Markets José Luis Moreno Florencia Radizza
This note is also available at PharmaMar website:
www.pharmamar.com
Fernando Mugarza (Media Relations), José Luis Moreno or Florencia Radizza (Capital Markets), +34-91-444-4500)
Tags: June 8, Madrid, Pharmamar, Scandinavia, Western Europe