Allergy receives FDA approval to progress Phase III allergy vaccine studyComtex News Network
Aug 23, 2012 (Datamonitor via COMTEX) --Allergy Therapeutics plc, a pharmaceutical company focused on allergy vaccination, has received the FDA approval to progress with a Phase III efficacy study, to be conducted in an Environmental Exposure Chamber, or EEC for the company's grass pollen allergy vaccine clinical development program.
FDA has confirmed that the clinical hold in the US dated 2007 has been lifted on the company's grass pollen allergy vaccine, or Grass MATA MPL/ Pollinex Quattro Grass 0.5ml, clinical development program. The company is focused on securing a partner to commercialize Pollinex Quattro in the US.
Allergy is planning to progress Phase III development of their ultra short course allergy vaccines in the US. These four shot products are based on the adjuvant MPL, the company's TLR4-agonist which acts to stimulate and re-direct the immune response.
The Pollinex Quattro allergy vaccines, which are already commercialized in European countries under a named patient basis, require only four injections per year and have the potential to transform allergy treatment in the US, providing vaccination to allergic rhinitis sufferers. The FDA's decision to lift the clinical hold marks an important step in the development of Pollinex Quattro for the treatment of grass allergy in the US, the company said.
Manuel Llobet, CEO, commented: "We are pleased that the FDA has decided to lift the clinical hold on our Pollinex Quattro program. This product has the potential to greatly benefit allergy sufferers in the US in the absence of registered products by being the first subcutaneous immunotherapy vaccine to reach the US market. Additionally, lifting of the hold will allow for discussions with potential partners with whom we will finalize the clinical development and start the commercialization of Pollinex Quattro in a market estimated to be around $2 billion."http://www.datamonitor.comRepublication or redistribution, including by framing or similar means,is expressly prohibited without prior written consent. Datamonitor shallnot be liable for errors or delays in the content, or for any actionstaken in reliance thereon