Pharming Announces Positive Results From Rhucin Open-label Clinicial Studies
The positive results are from the treatment of 123 acute HAE attacks in 64 patients with different doses of Rhucin® in the ongoing European and North American open-label studies. Rhucin® has been consistently safe and effective in patients receiving up to nine treatments with no evidence of decreased response to the study drug. Importantly, all seven serious laryngeal attacks treated in these studies responded rapidly to Rhucin®. The open-label data are consistent with findings from Pharming’s two randomized, double-blind, placebo-control led studies of Rhucin® with a median time to onset of relief of one hour and a median time to minimal symptoms of four hours.
Dr. Bruno Giannetti, Chief Operations Officer at Pharming, commented: “We are very pleased with these positive results with Rhucin®. They confirm the clinical benefits of Rhucin®, also in repeat treatment, without showing any adverse reactions or immune responses. Furthermore, the total number of treatments has substantially increased, including the successful treatment of serious potentially life-threatening laryngeal attacks. We very much appreciate the support of the investigators and patients with HAE with these clinical trials. These studies are an important contribution to making Rhucin® available for HAE patients worldwide.”
The results from open-label studies confirm Rhucin® to be safe and effective in the repeat treatment of acute HAE attacks at different dosage regimens. No clinically relevant adverse reactions were reported from these studies. The open-label treatments represent a sub stantial increase to the Rhucin® clinical database and will be used to support planned regulatory submissions. About Rhucin® and HAE Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming’s proprietary technology where the human protein is expressed in milk of transgenic rabbits. Rhucin® is currently under development for treatment of patients with acute attacks of Hereditary Angioedema (HAE). HAE is a human genetic disorder caused by a shortage of C1 inhibitor activity and results in an overreaction of the immune system. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which may last up to five days when untreated. About Pharming Group NVPharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® for Hereditary Angioedema and human lactoferrin for use in food products. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage).
Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
Posted: July 2008