Mental HealthPharmaMar Announces The Initiation Of Phase I Clinical Trials With PM1183, A New Antitumor Compound
PharmaMar SA (Grupo Zeltia, ZEL.MC) announces the initiation of Phase I clinical trials with PM1183, a new antitumor compound developed by
PharmaMar"s internal research program. The first patient enrolled in the trial has already
started treatment with the compound.
PM1183 is a new synthetic alkaloid which binds to the minor groove of DNA, generates DNA
double strand breaks and caused cell cycle perturbation that finally results in a specific type
of cell death calles apoptosis. Results from preclinical studies indicate a pattern of activity of
PM1183 different from that of conventional alkylating agents.
In preclinical studies PM1183 demonstrated strong in vitro and in vivo antitumoural activity
in a wide variety of tumour cell lines and human transplantable xenografted tumours.
PM11883 also demonstrated a manageable and reversible preclinical toxicology profile.
As a single agent, PM1183 significantly reduced tumor proliferation in vivo, with the
strongest effect observed on the xenografts of the breast cancer cell line MX1. PM1183 was
also evaluated for in vivo activity using M5076 sarcoma model that spontaneously
metastasizes in the liver of the C57Bl/6 female tumor bearing mice. The compound
statistically reduced the number of liver metastasis compared to placebo-treated animal.
In vitro studies show cell lines with mutant p53 or lacking P53 are more sensitive with
PM1183. Further studies are on going in human ovarian cancer and human sarcoma
xenografts.
PharmaMar"s clinical portfolio currently includes five new, first-in-class compounds:
Yondelis®, Aplidin®, Zalypsis®, Irvalec® and PM1183. The PharmaMar patent portfolio is
composed of over 1,800 files and it has a continous flow of new compound into the clinic (1
new compound every 24 months).
About PM1183
PM1183 is a new synthetic alkaloid compound developed by PharmaMar"s internal research
program. It binds to the minor groove of DNA, generates DNA double strand brakes and caused cell
cycle perturpation mainly consisting in a delayed progression of S phase and cycle arrest in G2M.
Results from preclinical studies indicate a pattern of activity of PM1183 different from that of
conventionaol alkylating agents.
PharmaMar
PharmaMar is the world leader biopharmaceutical company of the Zeltia Group, committed to
advancing the treatment of cancer through the discovery and development of new marine-derived
medicines. PharmaMar"s first product, Yondelis®, received marketing authorisation from the European
Commission for the treatment of advanced or metastatic soft tissue sarcoma in September 2007. In
2008 a registration dossier was submitted to the European Medicines Agency (EMEA) and Food and
Drug Administration (FDA, USA) for Yondelis® when administered in combination with
DOXIL®/Caelyx™ (pegylated liposomal doxorubicin) for the treatment of women with relapsed ovarian
cancer. It is also in phase II clinical trials for prostate, breast, and lung cancers. Three other
PharmaMar compounds, Aplidin®, Irvalec®, and Zalypsis® are in various stages of clinical
development.
PharmaMar