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2008/OB/02
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OXFORD BIOMEDICA ANNOUNCES DEVELOPMENT MILESTONE IN ITS COLLABORATION WITH MOLMED
Oxford, UK - 22 January 2008 :Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that its partner MolMed has received regulatory approval 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 product employs Oxford BioMedica?s retroviral ex vivo gene delivery technology. The start of a Phase III trial of TK therapy triggers an undisclosed milestone payment to Oxford BioMedica. MolMed has today issued a press release relating to the 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 on novel anti-tumour therapies, announced that the AIFA, the Italian Health authority, authorised the start in Italy of a Phase III trial (TK008) of MolMed?s TK cell therapy in patients affected by high risk acute leukaemias and receiving haematopoietic stem cell transplantation from a partially compatible family donor (haplo-HSCT). AIFA clearance, the very first one in Italy for a Phase III of a cell/gene therapy, requires the completion of analytical characterisation of TK components within the treatment of 20% of patients involved in the study, and follows approval of the clinical protocol, obtained in December 2007 by the Ethical Committee of the first clinical centre involved. In preparing Phase III, MolMed was supported by the EMEA, that provided protocol assistance and scientific advice as granted by the Orphan Drug designation of TK (Orphan Drug is awarded to therapeutics for life-threatening or chronically debilitating conditions affecting not more than 5/10,000 people in the EU). The multicentric, randomised Phase III trial will assess the very positive outcome of Phase I/II trial TK007 that resulted in an exceptional improvement in survival of patients by promoting rapid and sustained immune reconstitution, and proved safety and efficacy of haplo-HSCT, thus enabling feasibility of transplantation 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 of TK therapy in making stem cell transplantation available for all candidate patients lacking a fully compatible donor, who are approximately 60% of those who could benefit from this potentially curative treatment". Marco Dieci, Director of Quality & Regulatory Compliance at MolMed, added: "This approval is particularly meaningful also because TK is one of the very few cell/gene therapies in Phase III all over the world, and thus could be among the very first 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).
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| Notes
| 1. |
Oxford BioMedica plc |
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Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene-based therapies with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin-out from Oxford University, and is listed on the London Stock Exchange.
The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. In oncology, the lead product candidate is TroVax®, an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and two Phase III trials in colorectal cancer are planned. Oxford BioMedica has two other anti-cancer product candidates in Phase II development for melanoma and pancreatic cancer respectively. In neurotherapy, the Company has submitted a Clinical Trial Application to start a Phase I/II trial of its gene-based treatment for Parkinson’s disease, ProSavin®. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair.
The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 80 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include sanofi-aventis for TroVax and Wyeth for an anti-cancer targeted antibody therapy. The Company also has collaborations with Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. |
| 2. |
Acute leukaemia |
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High-risk acute leukaemia is a haematological malignancy for which the only potentially curative treatment is transplantation of haematopoietic stem cells (HSCT) from a healthy donor. However, feasibility and effectiveness of HSCT are heavily limited by the shortage of fully compatible donors, which are available only for approximately 30-40% of the patient population. Partially compatible (haploidentical) family donors would be available for nearly all patients, but at present safety and efficacy of this type of transplant is limited by a high rate of transplant-related mortality associated with delayed immune reconstitution. |
| 3. |
TK therapy |
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TK therapy is based on the use of genetically engineered (TK+) donor T lymphocytes, used in association with haplo-HSCT. TK+ donor lymphocytes can control the main complications associated with haplo-HSCT, while maintaining the anti-leukaemia effects of the transplant, thereby increasing both patients? survival and the number of available donors. Orphan drug designation for TK has been granted by the EMEA in 2003 and by the FDA in 2005. MolMed?s strategic partner Takara Bio Inc. (Japan) is developing TK for the Asian markets.
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| 3. |
MolMed |
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MolMed S.p.A is a biotechnology company focused on R&D and clinical validation of novel anticancer therapies. MolMed has two other anti-tumour therapeutics in clinical development: ARENEGYR, a novel vascular targeting agent (VTA), in Phase II in four indications; M3TK, a therapeutic vaccine, in Phase I/II in advanced melanoma. MolMed?s clinical pipeline is supported by a broad portfolio of therapeutic candidates. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy.
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