Advanced Accelerator Applications (AAA), an emerging international leader in molecular nuclear medicine, announced that it has received GMP (Good Manufacturing Practice) approval for the manufacture of Lutate, a radioactively labelled peptide that can be used to treat metastatic GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs).
The approval by the Italian Pharmaceutical Regulatory Authority (AIFA) will enable AAA to manufacture Lutate at its facility in Colleretto Giacosa, near Turin, Italy, making it the first industrial facility in the world approved to produce radio-labelled peptides for molecular nuclear therapy.
Neuroendocrine tumors are a rare group of tumors that start in the cells of the neuroendocrine system, a network of endocrine glands and cells throughout the body. Most GastroEnteroPancreatic tumors (GEPs) develop in the digestive system, usually starting in the stomach, bowel or pancreas.
Lutate,177Lutetium?DOTA0-Tyr3-Octreotate, is a radiolabeled somatostatine analog which selectively targets somatostatine receptors which are over-expressed in tumor cells. The product was developed by AAA’s wholly-owned subsidiary, BioSynthema Inc, based in St Louis, Missouri, USA.
Lutate has been shown to be an effective and safe treatment for GEP-NETs in an investigator-sponsored clinical study at the Erasmus Medical Center, Rotterdam, Netherlands, where over 600 patients have been treated with this innovative radiopharmaceutical. The study showed Lutate extended patients’ lives by between 3.5 and six years in comparison to current treatments, including chemotherapy. It was also shown to significantly improve quality of life, as measured by a number of function and symptom scales, especially in patients with proven tumor regression.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have indicated the need for a Phase III study in order to prepare Lutate for registration. AAA has started a Parallel Scientific Advice (PSA) from the EMEA and FDA to discuss its Phase III protocol. The PSA system was introduced in 2006 to allow both agencies to exchange scientific views during the development phase of new drugs. AAA hopes to start a multicenter Phase III study in 2011 in both Europe and the United States, with potential approval anticipated in 2015.
Lutate has been granted Orphan Drug status by both the FDA and EMEA, which gives it protection from competition for seven years in the US and 10 years in Europe following approval.
Stefano Buono, Chief Executive Officer of AAA, commented “We hope that manufacturing Lutate for clinical study use and the absence of a valid therapeutic alternative will open up the possibility of treating patients in many countries during the registration phase. We anticipate that the Colleretto Giacosa site and a second potential facility for the production of Lutate and other Radio Metabolic Therapies at the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori) in Meldola, Italy, would be able to produce sufficient quantities of Lutate to meet European demand, as well as developing new drugs.”
Dr. Jack Erion, CEO of BioSynthema, added, “Since merging with AAA we have reformulated Lutate to facilitate its use as a ready-to -use injectable drug. We have requested a Parallel Scientific Advice from EMA and FDA to discuss the Phase III protocol as this relatively new procedure seems particularly adapted to the development of Orphan Drugs”.
Date: December 16, 2010
Source: Advanced Accelerator Applications
Filed Under: Drug Discovery