Celacade

Celacade is a non-pharmacological treatment also known as Immune Modulation Therapy (IMT), developed by the Canadian based biotherapeutics company Vasogen, for treatment of chronic heart failure and peripheral artery disease. [cite journal |author=Visioli F |title=VasoCare. Vasogen |journal=Curr Opin Investig Drugs |volume=2 |issue=9 |pages=1247–9 |year=2001 |month=Sep |pmid=11717811 |doi= |url=] [cite journal |author= |title=Immune modulation therapy-peripheral vascular disease--Vasogen (VasoCare) |journal=Drugs R D |volume=3 |issue=5 |pages=358–60 |year=2002 |pmid=12455159 |doi= |url=]

At the World Congress of Cardiology in September 2006 the Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy (ACCLAIM) a phase III randomized, double-blind, placebo-controlled clinical trial involving some 2408 patients in 7 countries with left ventricular ejection fraction of 30% or less, reported that patients with a previous cardiovascular event receiving celacade where 39% less likely to die or be hospitalized due to a heart attack or stroke and tended to have improved quality of life. [cite journal |author=Torre-Amione G, Bourge RC, Colucci WS, "et al" |title=A study to assess the effects of a broad-spectrum immune modulatory therapy on mortality and morbidity in patients with chronic heart failure: the ACCLAIM trial rationale and design |journal=Can J Cardiol |volume=23 |issue=5 |pages=369–76 |year=2007 |month=Apr |pmid=17440642 |doi= |url=] Celacade is believed to inhibit inflammation, platelet aggregation and progression of arterial lesions by a mechanism independent of cholesterol lowering. [cite journal |author=Babaei S, Stewart DJ, Picard P, Monge JC |title=Effects of VasoCare therapy on the initiation and progression of atherosclerosis |journal=Atherosclerosis |volume=162 |issue=1 |pages=45–53 |year=2002 |month=May |pmid=11947896 |doi= |url=http://linkinghub.elsevier.com/retrieve/pii/S0021915001006803]

Celcade is a device-based outpatient procedure involving ex vivo exposure of 10ml autologous blood to heat, ultraviolet irradiation, controlled oxidative ozone therapy and subsequent intramuscular administration at monthly intervals. [cite journal |author=Bulmer J, Bolton AE, Pockley AG |title=Effect of combined heat, ozonation and ultraviolet irradiation (VasoCare) on heat shock protein expression by peripheral blood leukocyte populations |journal=J. Biol. Regul. Homeost. Agents |volume=11 |issue=3 |pages=104–10 |year=1997 |pmid=9498159 |doi= |url=]

The results of ACCLAIM support the hypothesis that immune dysfunction plays a role in the pathogenesis of atherosclerosis [cite journal |author=Mari D, Di Berardino F, Cugno M |title=Chronic heart failure and the immune system |journal=Clin Rev Allergy Immunol |volume=23 |issue=3 |pages=325–40 |year=2002 |month=Dec |pmid=12402415 |doi=10.1385/CRIAI:23:3:325 |url=] and Immune Modulation therapy has a broad-spectrum positive effect on a number of immune mediators, including regulation and enhancement of cytokines and the vascular dilator nitric oxide. These cell signaling molecules regulate inflammation and facilitate the healing process. [ cite web |url= http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,834,030.PN.&OS=PN/5,834,030&RS=PN/5,834,030 | title=Method of increasing the concentration of nitric oxide in human blood | publisher= United States Patent # 5,834,030 ] [ cite web |url= http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,591,457.PN.&OS=PN/5,591,457&RS=PN/5,591,457 | title=Method of inhibiting the aggregation of blood platelets and stimulating the immune systems of a human | publisher=United States patent # 5,591,457. 1997] [cite journal |author=Torre-Amione G, Sestier F, Radovancevic B, Young J |title=Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression |journal=Am. J. Cardiol. |volume=95 |issue=11A |pages=30C–37C; discussion 38C–40C |year=2005 |month=Jun |pmid=15925562 |doi=10.1016/j.amjcard.2005.03.010 |url=] [cite journal |author=Torre-Amione G, Sestier F, Radovancevic B, Young J |title=Effects of a novel immune modulation therapy in patients with advanced chronic heart failure: results of a randomized, controlled, phase II trial |journal=J. Am. Coll. Cardiol. |volume=44 |issue=6 |pages=1181–6 |year=2004 |month=Sep |pmid=15364317 |doi=10.1016/j.jacc.2004.06.047 |url=]

Vasogen in collaboration with Grupo Ferrer Internacional has regulatory approval to market Celacade as a medical device for the treatment of chronic heart failure in the European Union and Latin America. [ cite web |url=http://www.vasogen.com/sec/pr_1176892968 | title=Vasogen and Grupo Ferrer Form Collaboration to Commercialize Celacade in the European Union | publisher=Vasogen Inc April 18, 2007]

In the United States the FDA has recommended that Vasogen conduct a further confirmatory study to support a pre-market approval filing. [ cite web |url= http://www.vasogen.com/sec/pr_1182920278 | title= Vasogen Reports on Outcome of FDA Meeting | publisher= Vasogen press release - June 27, 2007]

References

External links

* [http://www.vasogen.com/sec/immune Celacade page on the Vasogen website]