Allergy Therapeutics gains as FDA lifts hold on grass vaccine
Allergy Therapeutics plc (LSE:AGY) jumped 3.12p (36%) to 11.75p on Friday after FDA lifted a clinical hold on the company's Pollinex Quattro Grass allergy vaccine and agreed to the proposed protocol for a Phase III trial. In 2007, FDA placed the hold on the company's Pollinex Quattro vaccine program -- which included vaccines for grass, ragweed and tree allergies -- following a rare neurological adverse event in a Phase III trial of the grass vaccine. The company plans to find a partner for Pollinex Quattro in the U.S.
The subcutaneous grass vaccine is formulated with allergoids, tyrosine, and the toll-like receptor 4 (TLR4) agonist monophosphoryl lipid A (MPL). Details of the trial design were not disclosed. An MAA for the grass allergy vaccine is under review in the EU, where the vaccine has been available in several countries under a named-patient basis. ...