London, UK; Brentwood, TN, US; 24 June 2008 - Protherics PLC (“Protherics” or the “Company”), the international biopharmaceutical company focused on critical care and cancer, today announces that the first patient has been enrolled in a phase 2a study of its Angiotensin Therapeutic Vaccine (ATV) for the treatment of hypertension.
Hypertension is a major risk factor for serious and common cardiovascular diseases such as heart attacks and strokes and the global market for anti-hypertensive therapies is estimated to be worth around US$30 billion*. The majority of existing therapies are tablets which need to be taken on a daily basis, usually for the rest of a patient’s life. However, many patients with high blood pressure fail to take their medicines as prescribed, and it is estimated that approximately 70% of patients with hypertension do not have their blood pressure adequately controlled*. Therefore, a vaccine approach, which may require only three injections and a booster after six months rather than daily medication, should improve patient compliance with treatment.
The phase 2a, double-blind, placebo-controlled clinical study in 124 patients with mild to moderate hypertension has been initiated in the UK. Patients will be given a course of injections over six weeks. The study will assess the safety and tolerability of the vaccine, incorporating Protherics’ promising novel vaccine adjuvant, CoVaccine HT™. In addition both antibody response and effect on blood pressure will be assessed. The blood pressure results are expected in the first half of 2009.
Protherics has shown in a previous phase 2a study that a formulation of ATV, incorporating the vaccine adjuvant Alhydrogel®, modulated key hormones involved in regulating blood pressure in hypertensive patients. A new formulation of ATV has now been developed, incorporating the CoVaccine HT™ adjuvant, which has demonstrated a much stronger immune response in pre-clinical models.
CoVaccine HT™ and ATV are protected by extensive patents and applications in the US, EU and the rest of the world. The first US patent on ATV was granted in May 2008.
Andrew Heath, Chief Executive of Protherics, commented:
“We are excited about the prospects for ATV, a potential value driver for the company. A vaccine approach to the treatment of high blood pressure promises to address the issue of poor patient compliance with daily medication and thus reduce the incidence of stroke and heart attacks. With data expected within a year, this could be a major outlicensing opportunity.”
For further information please contact:
Protherics
Nick Staples, Director of Corporate Affairs +44 (0) 7919 480510 Saul Komisar, President, Protherics Inc +1 615 327 1027
Financial Dynamics – press enquiries
London: Ben Atwell, Lara Mott +44 (0) 20 7831 3113
New York: John Capodanno +1 212 850 5600
Or visit www.protherics.com
