Oxford Biomedica Regulatory News (OXB)

22 Jan 2008 07:00

Oxford Biomedica PLC22 January 2008 For Immediate Release 22 JANUARY 2008 OXFORD BIOMEDICA ANNOUNCES DEVELOPMENT MILESTONE IN ITS COLLABORATION WITH MOLMED Oxford, UK - 22 January 2008: Oxford BioMedica (LSE: OXB), a leading genetherapy company, announced today that its partner MolMed has received regulatoryapproval to start a Phase III trial of TK therapy for high risk acute leukaemia.Under a license agreement with Oxford BioMedica, MolMed's TK therapy productemploys Oxford BioMedica's retroviral ex vivo gene delivery technology. Thestart of a Phase III trial of TK therapy triggers an undisclosed milestonepayment to Oxford BioMedica. MolMed has today issued a press release relating tothe Phase III trial, as follows: MolMed gets regulatory approval to start a Phase III trial in Italy of its TK therapy for high risk acute leukaemia Milan, Italy - 22 January 2008: MolMed S.p.A., a biotech company focused onnovel anti-tumour therapies, announced that the AIFA, the Italian Healthauthority, authorised the start in Italy of a Phase III trial (TK008) ofMolMed's TK cell therapy in patients affected by high risk acute leukaemias andreceiving haematopoietic stem cell transplantation from a partially compatiblefamily donor (haplo-HSCT). AIFA clearance, the very first one in Italy for aPhase III of a cell/gene therapy, requires the completion of analyticalcharacterisation of TK components within the treatment of 20% of patientsinvolved in the study, and follows approval of the clinical protocol, obtainedin December 2007 by the Ethical Committee of the first clinical centre involved.In preparing Phase III, MolMed was supported by the EMEA, that provided protocolassistance and scientific advice as granted by the Orphan Drug designation of TK(Orphan Drug is awarded to therapeutics for life-threatening or chronicallydebilitating conditions affecting not more than 5/10,000 people in the EU). Themulticentric, randomised Phase III trial will assess the very positive outcomeof Phase I/II trial TK007 that resulted in an exceptional improvement insurvival of patients by promoting rapid and sustained immune reconstitution, andproved safety and efficacy of haplo-HSCT, thus enabling feasibility oftransplantation from partially incompatible family donors. Claudio Bordignon, President and Chief Executive Officer of MolMed, commented:"The remarkable results obtained in the Phase I/II trial show the importance ofTK therapy in making stem cell transplantation available for all candidatepatients lacking a fully compatible donor, who are approximately 60% of thosewho could benefit from this potentially curative treatment". Marco Dieci,Director of Quality & Regulatory Compliance at MolMed, added: "This approval isparticularly meaningful also because TK is one of the very few cell/genetherapies in Phase III all over the world, and thus could be among the veryfirst ones to obtain marketing approval". This year, MolMed also plans to start a Phase I/II trial of TK in the US,managed by the MD Anderson Cancer Center in Houston (Texas). -Ends- For further information, please contact:Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000JPMorgan Cazenove Limited James Mitford/Gina Gibson Tel: +44 (0)20 7588 2828City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000Buchanan CommunicationsScientific/Trade Press Enquiries: Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020 College Hill Life SciencesMolMed SpA Tel: +39 02 21277 1 Elena Lungagnani, Communication managerUS Enquiries: Thomas Fechtner Tel: (646) 378 2900 The Trout Group LLC Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising incancer immunotherapy and gene-based therapies. The Company was established in1995, as a spin-out from Oxford University, and is listed on the London StockExchange. The Company has a platform of gene delivery technologies, which are based onhighly engineered viral systems. Oxford BioMedica also has in-house clinical,regulatory and manufacturing know-how. The lead product candidate is TroVax(R),an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventisfor global development and commercialisation. A Phase III trial of TroVax inrenal cancer is ongoing and Phase III development in colorectal cancer isplanned. Oxford BioMedica has three other products in clinical development,including ProSavin(R), a novel gene-based treatment for Parkinson's disease, ina Phase I/II trial. The Company is underpinned by over 80 patent families, whichrepresent one of the broadest patent estates in the field. The Company has astaff of approximately 85. Oxford BioMedica has collaborations withsanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licenseesinclude Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. Acute leukaemia High-risk acute leukaemia is a haematological malignancy for which the onlypotentially curative treatment is transplantation of haematopoietic stem cells(HSCT) from a healthy donor. However, feasibility and effectiveness of HSCT areheavily limited by the shortage of fully compatible donors, which are availableonly for approximately 30-40% of the patient population. Partially compatible(haploidentical) family donors would be available for nearly all patients, butat present safety and efficacy of this type of transplant is limited by a highrate of transplant-related mortality associated with delayed immunereconstitution. 3. TK therapy TK therapy is based on the use of genetically engineered (TK+) donor Tlymphocytes, used in association with haplo-HSCT. TK+ donor lymphocytes cancontrol the main complications associated with haplo-HSCT, while maintaining theanti-leukaemia effects of the transplant, thereby increasing both patients'survival and the number of available donors. Orphan drug designation for TK hasbeen granted by the EMEA in 2003 and by the FDA in 2005. MolMed's strategicpartner Takara Bio Inc. (Japan) is developing TK for the Asian markets. 4. MolMed MolMed S.p.A is a biotechnology company focused on R&D and clinical validationof novel anticancer therapies. MolMed has two other anti-tumour therapeutics inclinical development: ARENEGYR, a novel vascular targeting agent (VTA), in PhaseII in four indications; M3TK, a therapeutic vaccine, in Phase I/II in advancedmelanoma. MolMed's clinical pipeline is supported by a broad portfolio oftherapeutic candidates. MolMed is headquartered at the San Raffaele BiomedicalScience Park in Milan, Italy. This information is provided by RNS The company news service from the London Stock Exchange