Presentation of Phase IIa Results for Cytos Biotechnology’s Hypertension Vaccine at the American Heart Association Scientific Sessions 2007
- Oral presentation by Prof. Juerg Nussberger, MD, today at 9.45
am (EST): “CYT006-AngQb, a vaccine against hypertension
targeting angiotensin II, reduces early-morning and day-time blood
pressure.”
- The American Heart Association publishes today an independent
News Release about CYT006-AngQb.
- Excellent long-term safety and tolerability profile confirmed: no
vaccinerelated adverse events reported in 12 months follow-up
period.
SCHLIEREN (ZURICH), Switzerland and ORLANDO, Florida, USA, November
6, 2007 - Prof. Juerg
Nussberger, MD, University Hospital of the Canton of Vaud (CHUV),
in Lausanne, Switzerland, presents today detailed results of a
placebo-controlled, double-blind phase IIa clinical trial with
CYT006-AngQb in 72 patients with mild to moderate hypertension. In
addition, the American Heart Association publishes today at the
time of presentation an independent News Release about the vaccine
CYT006-AngQb. For more information on this report please visit
www.scientificsessions.org.
The study was designed to evaluate safety, tolerability, and
exploratory efficacy of two dose levels of the vaccine (100 ?g and
300 ?g). For efficacy evaluation, the change in blood pressure from
baseline to post-treatment was assessed in individual subjects by
24-hour ambulatory blood pressure monitoring.
Both dose levels of CYT006-AngQb tested were safe and well
tolerated. The majority of side effects observed were transient and
mostly mild local injection site reactions. During the entire
safety follow-up period from month 4 to 12 after the first
injection, no vaccine-related adverse events were reported. This
confirms the excellent safety and tolerability profile of the
vaccine and underscores its potential for long-term disease
management.
All patients who received the vaccine mounted a strong antibody
response against angiotensin II, which was dose-dependent and
long-lived but reversible with a half-life of about 4 months. Also
efficacy was dose-dependent and a significant reduction of the mean
ambulatory day-time blood pressure was observed in the group who
received the 300 ?g dose of the vaccine. Systolic blood pressure
(SBP) was reduced by 5.6 mmHg and diastolic blood pressure (DBP) by
2.8 mmHg from baseline.
Furthermore, strong efficacy of the vaccine was observed in the
early morning hours, a critical time period when serious
cardiovascular events occur frequently. The early morning rise of
blood pressure starting at 5 am was significantly reduced by the
vaccine, leading at 8 am to a blood pressure difference from
baseline of (SBP / DBP) - 25 / - 13 mmHg compared to placebo.
Prof. Juerg Nussberger comments: “Despite the fact that
effective drugs are available to treat hypertension, only about one
out of four hypertensive patients has the blood pressure
successfully controlled. Once people are aware of the often
symptomless hypertension, they have to take their medications
daily, and many are apparently unable or unwilling to take pills
every day for the rest of their lives. The major remaining medical
need in this important therapeutic area is thus improved patient
compliance. If we could support or substitute the oral therapy with
a vaccine that wouldneed to be given just every few months, I think
we could achieve a better control of high blood
pressure.”
Prof. Nussberger adds: “A particularly interesting finding of
this study is the excellent control of the blood pressure in the
early morning hours achieved by the vaccine. This is a crucial time
period when serious events like myocardial infarction and stroke
are more likely to occur than during other times of the day. Since
currently available drugs often have too short half-lives to affect
the rise in early morning blood pressure, this could become a major
advantage of the novel vaccine approach. I am looking forward to
the next steps in clinical development for this promising vaccine
candidate.”
About CYT006-AngQb
CYT006-AngQb is a therapeutic vaccine in development for treatment
of hypertension1. It is designed to instruct the patient’s
immune system to produce an antibody response against angiotensin
II. Angiotensin II is a small peptide in the body and part of the
renin-angiotensin system (RAS), which is an important regulator of
blood pressure. Angiotensin II causes blood vessels to narrow,
resulting in increased blood pressure. Vaccination with
CYT006-AngQb has been shown to reduce blood pressure by induction
of antibodies that bind angiotensin II. Thereby, binding of
angiotensin II to its receptors and subsequent narrowing of blood
vessels should be decreased. The RAS has already been successfully
targeted by three major classes of antihypertensive drugs on the
market: inhibitors of the angiotensin-converting enzyme (ACEI),
blockers of the angiotensin II subtype I receptor (ARB) and direct
renin inhibitors (DRI). Like other antihypertensive drugs these
also come with the need for daily dosing and often fail to provide
a good solution for improving patient compliance. Treatment with
CYT006-AngQb should allow for convenient dosing schedules and
smooth control of blood pressure due to a sustained antibody
response induced by vaccination.
About hypertension
Hypertension, also termed high blood pressure, is a medical
condition where the blood pressure is chronically elevated.
Although symptomless in nature and in itself rarely an acute
problem, persistent hypertension is one of the most important
preventable causes of premature death worldwide and contributes to
around half of all cardiovascular diseases2. It is one of the major
risk factors for stroke, myocardial infarction, heart failure, and
vascular disease, and is a leading cause of chronic renal failure.
Genetic predisposition and lifestyle habits such as inadequate
physical activity, high fat diet, and high salt intake promote high
blood pressure. Up to 30% of adults in most countries suffer from
hypertension. Despite effective and relatively inexpensive
treatment available, only about one out of four hypertensive
individuals in the U.S. have their blood pressure controlled
successfully3. This poor overall treatment success is mainly
attributed to the symptomless nature of hypertension and the
necessity for long-term treatment with medications that require at
least once daily self-administration.
About early morning blood pressure
Blood pressure is not static but undergoes natural variations which
follow a circadian pattern. Highest levels are reached during the
morning, which then decline to reach a trough value at about
midnight. In the early morning, a steep increase in blood pressure
occurs naturally. It has been suggested that this morning rise in
blood pressure triggers adverse cardiovascular events. A large
study has revealed a marked circadian periodicity in the onset of
myocardial infarction with the primary peak incidence being in the
morning. At this time, myocardial infarction is three times as
likely to onset as during the night4. The same periodicity was
observed in the onset of stroke. Striking evidence suggests that
the morning rise in blood pressure is crucial in determining the
rupture of critically weakened arterial walls and subjects with a
large rise in morning blood pressure have a significantly elevated
risk of intracerebral haemorrhage5 and stroke6. Hypertension
therapy therefore aims at a full 24-hour blood pressure control.
Current small molecule inhibitors of the RAS were reported to
achieve an ambulatory blood pressure reduction from baseline in the
early morning hours of e.g. (SBP / DPB) - 8.7 / - 5.8 mmHg
(valsartan) and - 11.0 / - 7.6 mmHg (telmisartan), respectively.
They, however, do not abolish the rise in early morning blood
pressure7,8.
About Cytos Biotechnology AG
Cytos Biotechnology AG is a public Swiss biotechnology company that
specializes in the discovery, development
and commercialization of a new class of biopharmaceutical products
– the ImmunodrugsTM. ImmunodrugsTM are
intended for use in the treatment and prevention of common chronic
diseases, which afflict millions of people
worldwide. ImmunodrugsTM are designed to instruct the
patient’s immune system to produce desired therapeutic
antibody or T cell responses that modulate chronic disease
processes. Taking advantage of the high flexibility of its
ImmunodrugTM platform, Cytos Biotechnology has built a pipeline of
different ImmunodrugTM candidates in various disease areas, of
which 6 are currently in clinical development. The ImmunodrugTM
candidates are developed both in-house and together with Novartis
and Pfizer Animal Health. Founded in 1995 as a spin-off from the
Swiss Federal Institute of Technology (ETH) in Zurich, the company
is located in Schlieren (Zurich). Currently, the company has 130
employees. Cytos Biotechnology AG has been listed on the SWX Swiss
Exchange (SWX:CYTN) since October 2002.
For further information please contact:
Claudine Blaser, PhD
Director Corporate Communications
Cytos Biotechnology AG, Wagistrasse 25, CH-8952 Schlieren,
Switzerland
phone: +41 44 733 47 20, e-Mail: claudine.blaser@cytos.com,
website: www.cytos.com
References
1. Journal of Hypertension, 2007, 25:63.
2. World Health Organization, Atlas of Heart Disease and Stroke,
2004.
3. Hypertension 2003; 42:1206.
4. New England Journal of Medicine, 1985, 313:1315.
5. Hypertension, 2006, 47:149.
6. Hypertension Research, 2006, 29:581.
7. American Journal of Hypertension, 2004, 17:347.
8. Hypertension, 2003, 42:1137.
This foregoing press release may contain forward-looking statements
that include words or phrases such as “designed”,
“potential”, “would”, “should”,
“could”, “promising”,
“suggest”, “aim”, “intend” or
other similar expressions. These forward-looking statements are
subject to a variety of significant uncertainties, including
scientific, business, economic and financial factors, and therefore
actual results may differ significantly from
those presented. There can be no assurance that any other
therapeutic entities will enter clinical trials, that clinical
trial results will be predictive for future results, that
therapeutic entities will be the subject of filings for regulatory
approval, that any drug candidates will receive marketing approval
from the U.S. Food and Drug Administration or equivalent regulatory
authorities, or that drugs will be marketed successfully. Against
the background of these uncertainties readers should not rely on
forward-looking statements. The company assumes no responsibility
to update forwardlooking statements or adapt them to future events
or developments. This document does not constitute an offer or
invitation to subscribe or purchase any securities of Cytos
Biotechnology AG.
Posted: November 2007
