Published: August 10, 2011
New Tuberculosis Vaccine Enters Phase IIb Proof-of-Concept Trial in People Living with HIV in Senegal and South Africa
ROCKVILLE, Md. & LONDON - (BUSINESS WIRE) - Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) announce
today the start of a Phase IIb proof-of-concept efficacy trial of a new
investigational tuberculosis (TB) vaccine that involves people living
with the human immunodeficiency virus (HIV). The trial will be conducted
at research sites in Senegal and South Africa with primary funding
support from the European and Developing Countries Clinical Trials
Partnership (EDCTP).
TB is a leading cause of death for people infected with HIV and the
second leading infectious disease killer in the world. This is the first
proof-of-concept efficacy trial in people infected with HIV using
MVA85A, which is being developed by OETC (a joint venture between the
University of Oxford and Emergent BioSolutions) and Aeras. It is
expected that the trial will generate important safety, immunogenicity
and efficacy data about this vaccine.
The trial will test the vaccine candidate in approximately 1,400 adults
ages 18-50 who are infected with HIV. The study will be led by the UK
Medical Research Council in The Gambia, Aeras, and the University of
Oxford, and conducted at two sites by the University of Cape Town (UCT)
Institute of Infectious Disease and Molecular Medicine in Khayelitsha,
South Africa and Laboratoire de Bacteriologie-Virologie du Centre
Hospitalier Universitaire Aristide Le Dantec in Dakar, Senegal. This
follows the first proof-of-concept clinical trial of the same candidate
TB vaccine, which recently reached full enrollment with almost 3,000
infant participants in South Africa.
"Clinical trials of new vaccines against tuberculosis must be an urgent
priority on our agenda, as too many lives are lost to TB, especially
among people living with HIV," said Member of the European Parliament
Michael Cashman. "I recently visited a clinical trial site of this
vaccine candidate in infants in South Africa, and I was impressed with
the progress. I am anxious to see a new TB vaccine licensed, and I am
proud that European Union Member States are investing in this
critically-important work."
Professor Charles Mgone, Executive Director of EDCTP, said, "The TB and
HIV co-epidemic is devastating, requiring a concerted global response.
EDCTP in partnership with Aeras, Oxford-Emergent Tuberculosis Consortium
and others is committed to accelerate research and development of this
promising vaccine against tuberculosis by co-financing the clinical
trial as an essential part in its evaluation."
Tuberculosis kills 1.7 million people per year, and more than two
billion people worldwide are infected with TB - approximately one out of
every three people on the planet. People infected with HIV living in
countries with high TB prevalence are 20 times more likely to develop TB
than those who are HIV-negative. In 2008, there were an estimated 1.4
million new cases of TB among persons with HIV infection, and TB
accounted for 23 percent of AIDS-related deaths, according to the World
Health Organization (WHO). The Bacille Calmette-Guerin (BCG) vaccine,
the only currently-licensed vaccine against TB, is not effective in
preventing adult pulmonary TB, the most common form of the disease.
"A new, more effective TB vaccine would be game-changing in
international efforts to eliminate TB globally by 2050," said Jim
Connolly, President and Chief Executive Officer of Aeras. "Studies have
already shown that this promising vaccine has an acceptable safety
profile and stimulates strong immune responses in HIV-infected
individuals."
Aeras is the trial sponsor, and significant funding is provided by
EDCTP, a pan-European body that supports multicenter projects which
combine clinical trials, capacity building and networking. This study
has been approved by the Medicines Control Council of South Africa, the
South African Department of Health, and the Comite National d'Ethique
pour la Recherche en Sante (CNERS) in Senegal. The Scientific Institute
of Public Health (WIV-ISP) in Belgium, which first identified the
antigen 85A for possible use in a vaccine candidate, is providing
in-kind laboratory services for the study.
"Together with our partners, Emergent BioSolutions is proud to be
leading the development of a new vaccine to defeat TB, one of the
world's deadliest infectious diseases. This trial is particularly
critical because of its focus on adults living with HIV. If we are
successful, MVA85A will help make the dream of a world free from TB a
reality," said Fuad El-Hibri, Chairman and Chief Executive Officer of
Emergent BioSolutions.
"It is great to see the vaccine candidate we initially developed at
Oxford University reach this stage of clinical trials," said Dr. Helen
McShane, a Wellcome Trust Senior Clinical Research Fellow at the
University of Oxford. "In the next few years we should begin to get
results on how effective the vaccine is in protecting those who are most
at risk of TB. It's our hope that this vaccine will turn out to be a
powerful new weapon to combat TB in the parts of the world that need it
most."
About MVA85A
The MVA85A vaccine candidate is intended to boost the response of
T-cells already stimulated by the BCG vaccine. The vaccine candidate was
originally developed at the University of Oxford by Dr. Helen McShane, a
Wellcome Trust Senior Clinical Research Fellow, working with Dr. Sarah
Gilbert, a Reader in Vaccinology, and Professor Adrian Hill, a Wellcome
Trust Principal Research Fellow. It was licensed to the Oxford-Emergent
Tuberculosis Consortium by Isis Innovation, the University's technology
transfer company, in July 2008. Previous clinical trials of the vaccine
in adults - supported by the Wellcome Trust - in the United Kingdom, the
Gambia, Senegal and South Africa have demonstrated consistently high
cellular immune responses in those who received the MVA85A vaccine
candidate following vaccination with BCG. To date, the vaccine has been
shown to have an acceptable safety profile and has had no
clinically-significant effects on viral load or CD4 count in three
studies involving a total of 80 participants living with HIV in Senegal,
South Africa and the UK. The vaccine has been awarded orphan drug status
by the European Medicines Agency (EMA) and is the most clinically
advanced of a new generation of tuberculosis vaccine candidates.
About Aeras
Aeras is a non-profit product development organization dedicated to the
development of effective vaccines and biologics to prevent TB across all
age groups in an affordable and sustainable manner. Aeras has invented
or supported the development of six TB vaccine candidates to date, five
of which are currently undergoing Phase I and Phase II clinical testing
in Africa, Asia, North America and Europe. Aeras receives funding from
the Bill & Melinda Gates Foundation, other private foundations, and
governments. Aeras is based in Rockville, Maryland, USA where it
operates a state-of-the-art manufacturing and laboratory facility, and
Cape Town, South Africa. http://www.aeras.org
About OETC
The Oxford-Emergent Tuberculosis Consortium Ltd ("OETC" ) is a
joint venture between the University of Oxford and Emergent
BioSolutions. OETC was formed with the aim of developing the MVA85A TB
vaccine to meet both developed and developing country health needs.
About EDCTP
The European and Developing Countries Clinical Trials Partnership
(EDCTP) was created in 2003 as a European response to the global health
crisis caused by the three main poverty-related diseases (PRDs) of
HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership
between 14 European Union member states plus Norway and Switzerland with
47 sub-Saharan African countries. The aim of the programme is to
accelerate the development of new or improved drugs, vaccines and
microbicides against HIV/AIDS, malaria and tuberculosis through
promoting the integration of national programmes of EDCTP European
Member States and development of a genuine partnership with African
counterparts. http://www.edctp.org
About Emergent BioSolutions Inc.
Emergent BioSolutions protects and enhances life by developing and
manufacturing vaccines and therapeutics that are supplied to healthcare
providers and purchasers for use in preventing and treating disease.
Emergent's marketed and investigational products target infectious
diseases, oncology and autoimmune disorders. Additional information
about the company may be found at http://www.emergentbiosolutions.com
About Laboratoire de Bacteriologie-Virologie du Centre Hospitalier
Universitaire Aristide Le Dantec
Professor Souleymane Mboup is the Laboratory Director and the Principal
Investigator (PI) of this clinical trial in Senegal. The Laboratoire de
Bacteriologie-Virologie Le Dantec (LBV) is working in partnership with
the Infectious Disease Department of Fann Hospital led by co-PI
Professor Papa Salif Sow and the CTA (Centre for Ambulatory Treatment)
led by Dr. Ndeye Fatou Ngom. LBV is globally known for Professor Mboup's
co-discovery of the HIV-2 virus with a Harvard University team.
He was one of three major PIs to receive an NIH CIPRA Program award. The
Laboratory is engaged in many research areas including HIV, malaria,
Hepatitis B and neglected diseases. A dedicated research team has been
set up to take over this challenging Phase II vaccine trial, which will
be coordinated by Dr. Birahim Pierre Ndiaye, who has extensive
experience managing clinical studies. http://www.hopitaldantec.org/
About the Medical Research Council
For almost 100 years, the Medical Research Council (MRC) has improved
the health of people in the UK and around the world by supporting the
highest quality science. The MRC invests in world-class scientists. It
has produced 29 Nobel Prize winners and sustains a flourishing
environment for internationally-recognised research. The MRC focuses on
making an impact and provides the financial muscle and scientific
expertise behind medical breakthroughs, including one of the first
antibiotics penicillin, the structure of DNA and the lethal link between
smoking and cancer. Today MRC-funded scientists tackle research into the
major health challenges of the 21st century. MRC has units in Africa
dedicated to research on infectious diseases and non-communicable
diseases for such settings. Dr. Martin Ota, the Principal Investigator
and Project Coordinator of this important novel TB vaccine trial, is a
senior scientist from the MRC Unit The Gambia. http://www.mrc.ac.uk
About Oxford University's Medical Sciences Division
Oxford University's Medical Sciences Division is one of the largest
biomedical research centres in Europe, with over 2,500 people involved
in research and more than 2,800 students. It brings in around two-thirds
of Oxford University's external research income. Listed by itself, that
would make it the fifth largest UK university in terms of research
grants and contracts. A major strength of Oxford medicine is its
long-standing network of clinical research units in Asia and Africa,
enabling world-leading research on malaria, TB, HIV/AIDS and flu. Oxford
is also renowned for its large-scale studies into the causes and
treatment of cancer, heart disease, diabetes and other common
conditions. http://www.ox.ac.uk
About The Clinical Infectious Diseases Research Initiative
The Clinical Infectious Diseases Research Initiative at the University
of Cape Town was established in 2008 by a Strategic Award from the
Wellcome Trust of Great Britain. The Initiative is administered from the
IIDMM (Institute of Infectious Diseases and Molecular Medicine) by a
Steering Group under the direction of Professor Robert J Wilkinson. It
supports extensive research in Infectious Diseases, and one of the
objectives is to improve clinical and laboratory research facilities.
This is the first adult TB vaccine clinical trial to be launched
at the purpose built clinic at Site B Community Health Clinic,
Khayelitsha. http://www.cidri.uct.ac.za
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including any potential future securities
offering, our expected revenue growth and net earnings for 2011, and any
other statements containing the words "believes," "expects,"
"anticipates," "plans," "estimates" and similar expressions, are
forward-looking statements. There are a number of important factors that
could cause the actual results of the Consortium or Emergent to differ
materially from those indicated by such forward-looking statements,
including the success of our ongoing and planned preclinical studies and
clinical trials; the rate and degree of market acceptance and clinical
utility of our products; the success of our ongoing and planned
development programs; the timing of and our ability to obtain and
maintain regulatory approvals for our other product candidates; our
commercialization, marketing and manufacturing capabilities and
strategy; our estimates regarding expenses, future revenue, capital
requirements and needs for additional financing; and other factors
identified in Emergent's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2011 and subsequent reports filed with the SEC. The
Consortium and Emergent disclaim any intention or obligation to update
any forward-looking statements as a result of developments occurring
after the date of this press release.
Aeras
Jamie Rosen, +1-301-547-2853
jrosen@aeras.org
or
Emergent
Tracey
Schmitt, +1-301-795-1847
schmittT@ebsi.com
or
University
of Oxford
Jonathan Wood, +44 (0)1865 280530
jonathan.wood@admin.ox.ac.uk
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