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Celixir comes as a UK firm indulged in the discovery and development of life changing regenerative medicines and whilst working towards their common goals via collaborative partnerships. That said; let’s take a look at their collaborations with various recognized firms and institutions in the past few years. DAIICHI SANKYO Celixir has granted the Japan license for their innovative cardiac regeneration medicine to Daiichi Sankyo on May 2016. As per the agreement, Daiichi Sankyo will be taking care of all the development, regulatory and commercial activities regarding Celixir’s immunomodulatory progenitor cells within Japanese territory. On the other side, Celixir will be taking care of the worldwide rights for Celixir stem cells therapy for the rest of the world. INNOVATIVE CARDIOVASCULAR MEDICINES COLLABORATION Celixir has further formed the Innovative Cardiovascular Medicines Collaboration which includes global experts in cardiac research and clinical development, coming onboard with a common purpose of getting a basic understanding for cardiac regeneration. This Collaboration will be headed jointly by Professor Kim Fox, Consultant Cardiologist and Professor of Cardiology at Imperial College and Professor Sir Martin Evans celixir, who is a Nobel Laureate along with the Chief Scientific Officer of Celixir. The same collaboration will be supported by Professor John Pepper, OBE, Interim Director of Research at the Royal Brompton and Harefield NHS Foundation Trust, together with Dr. Sabena Sultan, Global Head of Research at Celixir stem cells office. Talking about the same collaboration, Ajan Reginald, CEO, of Celixir cell therapy, said, “Collaborations with world-class research physicians are critical in accelerating the development of innovative medicines. We’re delighted to be forming this partnership with Professors Fox and Pepper, to advance Celixir’s investigational myocardial regeneration medicine and provide future innovations that will hopefully transform patients’ lives”, The Collaboration was formed with the key priority of investigating heart failure whilst focusing on the progressive insights into the regeneration of cardiac tissue. Same collaboration would then think about bringing all the life-saving medicines to help and support millions of heart failure patients. TMC LIFE SCIENCES AND THOMSON MEDICAL Celixir cell therapy has also formed collaboration with TMC Life Sciences Bhd (TMCLS) and its flagship company, Thomson Medical (Thomson) to further trigger the discovery and development of life-changing and life-altering regenerative medicines. Going by the Memoranda of Understanding (MOU), Celixir will further be developing the educational programmes to successfully train all the medical professionals in regenerative medicine with their partner hospitals (TMCLS and Thomson). On the other side, TMCLS and Thomson will be providing an access to their pan-Asia development, clinical trials and hospital network. Celixir announces US FDA approval of the IND application for cell therapy Heartcel
Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for Heartcel its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval of a clinical trial application (CTA) from the UK’s Medicines and Healthcare products Regulatory Agency to initiate a potentially pivotal Phase II b human clinical trial with Heartcel The international trial will recruit up to 250 patients and the IND approval allows expansion to US clinical trial sites. Ajan Reginald, Chief Executive Officer of Celixir, commented: “The FDA approval of our IND is a significant regulatory milestone, which follows UK clinical trial approval in January. Celixir is now well positioned to conduct potentially pivotal trials with Heartcel™ in Europe and the US.” About Celixir Celixir is a privately owned UK biotechnology company that discovers and develops life-saving and life-altering advanced therapies for patients with the greatest medical need. Celixir, founded in 2009, is made up of a world class team of scientists and biopharmaceutical executives, led by Nobel Laureate Professor Sir Martin Evans and former Roche Global Head of Emerging Technologies, Ajan Reginald. Celixir’s unique platform technology allows it to adopt an ‘off-the-shelf’ approach to deliver cell therapies to patients. About Heartcel Heartcel is an allogeneic celixir cell therapy containing off-the-shelf immunomodulatory progenitor (iMP) cells engineered to regenerate the heart. Imps are administered during coronary artery bypass graft (CABG) surgery by direct injection around the cardiac scar that is to be regenerated. iMP cells have been designated an Advanced Therapeutic Medicinal Product (ATMP) by the European Medicines Agency. EU Phase II trials were successfully completed with results presented in 2016 at the congresses of the European Society of Cardiovascular and Endovascular Surgery and the European Society of Gene and Cell Therapy. All primary and secondary endpoints were met: 100% major adverse cardiac event (MACE) free survival; 30% improvement in heart function; 40% reduction in scar size; and 50% improvements in quality of life. In 2017, four-year follow-up analyses found the MACE-free survival rate remains at 100%. Potentially pivotal trials are approved to begin following US IND and UK CTA approvals. Just days after the Cardiff-based cell therapy company Cell Therapy Ltd (CTL) signed an agreement with Japan’s Daiichi Sankyo, providing them with the rights to its heart failure drug Heartcel, the company’s chief executive, Ajan Reginald, got interviewed by one of the leading dailies. Heartcel, an immune-modulator progenitor (iMP), can be considered as one of the allogeneic stem cell therapy which posses the power to redevelop the human heart. The same therapy has confirmed two-year MACE-free survival for all the tested patients in the Phase II clinical trial studying myocardial regeneration. As per the agreement, Daiichi Sankyo will take care of the development, regulatory approval and marketing of Heartcel in the Japanese territory, while CTL will still holds the rights for the rest of the world. Mr. Ajan Reginald, the co-founder of CTL, quoted that the deals comes as a future step towards accomplishing the global mission of bringing company’s life-saving drugs to the world’s markets within a short period of time. “Japan was a natural priority because it has an accelerated pathway that allows innovative regenerative medicines to reach patients much faster,” he said. “It is also very important commercially because it is the world’s second biggest pharmaceutical market.’ He also said that the company is ‘agnostic’ towards bringing these medicines to the global markets within a short period and they are open to all the available options in the same regards. “Partnerships are a tool, but sometimes we are the best company to do it. It varies by territory. In Japan Daiichi Sankyo was identified as the best partner”, he added. It was October last year when CTL received the permission for the conditional marketing authorization for Heartcel in European region. “There are multiple ways of bringing life-saving medicines to market, conditional approval is one way but there is also the Phase III route which is what we will do in the US,” he explains. He also confirmed that CTL is currently looking for a partner in the US on Heartcel and various other discussions are in pipeline for a European partnership for its second asset named, Tendoncel. This topical regenerative medicine which is quite helpful in treating certain severe tendon injury is geared up to enter its Phase III trials, after receiving positive results from Phase II. Mr. Ajan Reginald also puts his stamp on the healthy financial state of the company. “It is a private company, still managed by the founders, so we have been prudent in our use of funds and also prudent in our fundraising. We were well-capitalized ahead of this partnership.” he said He further expects an initial public offering (IPO) to be coming out anytime around next year. Ajan Reginald concluded the interview whilst saying, “I think we have a strategy which is to fund the company until the innovation and product revenues can drive sustainable development of our pipeline. We are not against an IPO but we won’t consider it until next year,” Celixir (formerly known as Cell Therapy Ltd.) is a private British regenerative medicine company that discovers and develops life-saving and life-altering regenerative medicines for patients with the greatest medical need. Celixir, founded in 2009, is made up of a world-class team of scientists and biopharmaceutical executives, led by Nobel Laureate Professor Sir Martin Evans and former Roche Global Head of Emerging Technologies, Ajan Reginald. Celixir’s unique platform technology allows us to adopt an ‘off-the-shelf’ approach to deliver regenerative medicines to patients. Website : http://www.celixir.com Headquarters : Cardiff, Wales Year Founded : 2009 Company Type : Privately Held Size : 11-50 employees Specialties : regenerative medicine, cell therapies, cardiovascular medicine, cellular research |
Celixir Ltd.Celixir (formerly known as Cell Therapy Ltd.) World-Class scientists and biotechnology leadership is devoted to discovering breakthrough regenerative Stem Cell medicines. Celixir is a team of world-class scientists and biotechnology leadership is devoted to discovering breakthrough medicines that change the standard of medical care for patients. ArchivesCategories |