Friday December 05 2008 | Biotechnology feed | All feeds
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Friday December 05 2008 | Biotechnology feed | All feeds
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PowderMed initiates a phase I clinical trial for a therapeutic Herpes Simplex type 2 vaccine Phase
I clinical trial in patients of therapeutic DNA vaccine for the treatment of
HSV2 commences at The Centre for Clinical Studies in Houston, Texas using
PowderMed’s novel DNA-on-Gold technology Oxford,
UK, 12 October 2004
– PowderMed Ltd (PowderMed), a company focusing on the development of
therapeutic DNA vaccines has announced that it has initiated a Phase I trial in
patients of a novel therapeutic DNA vaccine for the treatment of Herpes Simplex
Type 2 (HSV2). This therapeutic
vaccine uses PowderMed’s proprietary Particle Mediated Epidermal Delivery (PMED™)
technology to deliver a DNA plasmid coding for four HSV2 antigens.
The
HSV2 trial, being carried out at The Centre for Clinical Studies in Houston,
Texas is being conducted in 36 otherwise healthy individuals with recurrent
genital herpes caused by HSV2. In
addition to assessing the safety and tolerability of the vaccine, this study
will also assess the immune response of patients. PowderMed’s
DNA vaccines offer a promising new therapeutic intervention for a wide range of
diseases including Genital Herpes. This
therapeutic DNA vaccine has been shown to induce a cellular immune response
against four HSV2 antigens that appear very early in the viral replication
cycle. In this way the vaccine is
designed to treat Herpes patients by stopping viral reactivation and thus
preventing the recurrent genital lesions that cause these patients both physical
and psychological distress. Dr
Clive Dix, CEO of PowderMed, said: “Genital
Herpes, is a serious and prevalent viral disease that is difficult to control
pharmacologically. The therapeutic
DNA vaccine approach offers a significant new route to treatment that could help
many sufferers avoid recurrences and prevent onward transmission.
Together with the phase 1 HIV study which has recently begun in
collaboration with GlaxoSmithKline, the start of this HSV study marks the third
therapeutic vaccine programme from PowderMed to enter the clinic this year, and
we are very excited with our rapid progress.”” PowderMed’s
therapeutic vaccines use the company’s proprietary PowderJect® DNA
particle mediated epidermal delivery (PMED™) technology, which comprises of
DNA bound to microscopic gold particles that are propelled at high speed into
the skin. PMED™ is particularly
well suited for therapeutic vaccines, which require the induction of both
humoral and cellular immunity. -
ends - NOTES
FOR EDITORS
1.
About PowderMed Ltd – www.powdermed.com
PowderMed
Ltd, a leader in the development of therapeutic DNA vaccines, based in Oxford,
UK, was launched in May 2004 as a management spin out of the PowderJect
therapeutic DNA vaccine programmes, previously owned by Chiron Vaccines.
The Company has the rights to the PowderJect® DNA 2.
PowderJect® DNA particle mediated epidermal delivery (PMED)
technology Using
the PowderJect device, DNA precipitated onto microscopic gold particles, is
propelled by pressurised helium gas at near supersonic speeds into the
epidermis. The microscopic gold
particles (mean particle diameter 1 - 3 microns) are used as the carrier because
they have the appropriate size and density needed to deliver the DNA directly
into the immunologically active antigen presenting cells (APCs) of the
epidermis. These cells have a mean
diameter 20 microns and thus the microscopic gold can easily enter the cell.
Studies have shown that once inside the nuclei of APCs, the DNA elutes
off the gold and becomes transcriptionally active, producing the encoded protein
that when presented by the APCs to lymphocytes, triggers strong T-cell mediated
immune responses. It is this
ability of PMED to produce a robust and reproducible T-cell mediated immune
response to a broad range of viral and cancer antigens, that provides PowderMed
with its unique competitive advantage in the field of therapeutic vaccines. 3.
Therapeutic vaccines Therapeutic
vaccines are a new class of product, which harness the immune system in order to
produce a therapeutic effect. The
PowderJect technology has previously been tested in the clinic as a vaccine for
prophylaxis against Hepatitis B but will be used by PowderMed in the development
of therapeutic vaccines for chronic viral diseases, such as Genital Herpes, and
for cancer. 4.
Herpes Simplex Type 2 The
herpes simplex virus (HSV) causes blisters and sores around the mouth, nose,
genitals, and buttocks, but they may occur almost anywhere on the skin.
HSV infections can be very distressing because they tend to reappear
periodically, sometimes frequently, and the sores may be painful and unsightly.
There are two types of HSV — Type 1 and Type 2.
HSV type 1 tends to infect the vicinity of the mouth where it is commonly
referred to as fever blisters or cold sores, but it may also affect the
genitals; while HSV type 2 usually results in sores on the buttocks, penis,
vagina, or cervix, where it is generally referred to as Genital Herpes.
Sexual intercourse is the most frequent means of getting the infection.
Both primary and repeat attacks can cause problems including: a rash or
itching, painful sores, fever, aching muscles, and a burning sensation with
urination. The psychosexual impact
of infection can be significant. HSV
may also occur in other locations, including serious infections of the eye.
The frequency of repeated outbreaks can be as high as once every few
months. Herpes viruses are very
prevalent and up to one in five individuals are infected with the HSV2 virus. There
is no cure for recurrent genital herpes. 5.
A therapeutic vaccine targeting HSV2 PowderMed
has produced a DNA Plasmid (pPJV7630), which encodes the ICP0, ICP4, ICP22 and
ICP27 antigens that appear relatively early in the viral replication cycle of
HSV2. PPJV7630 is precipitated onto
the surface of gold particles 1 to 3 µM in diameter and will be administered to
patients by particle mediated epidermal delivery (PMED). Vaccination
with pPJV7630 has been shown to induce a cellular immune response.
It is believed that such an immune response in HSV2 patients may
interfere with the early stages of viral replication, before symptoms of HSV2
appear. In this way, the vaccine
would be intended to prevent recurrences of pre-existing HSV2. 6.
Phase I Clinical trial in patients with HSV2 Phase
I clinical trials are the first trials of a drug in humans.
They are usually short term trials in a small number of individuals
designed to evaluate preliminary safety of a compound in humans.
The present trial
will be conducted in 36 otherwise healthy subjects with recurrent genital herpes
caused by HSV2The primary objective of this first phase I clinical study is to
evaluate the safety and tolerability of the pPJV7630 HSV2 DNA vaccine
administered by PMED. The
immunogenicity of the pPJV7630 HSV2 DNA vaccine will also be measured.
7.
Phase
I Clinical trial of a therapeutic vaccine for the treatment of HIV The
Human Immunodeficiency Virus (HIV) is a retrovirus that leads infected
individuals to develop AIDS. Although
there are anti-retroviral treatments on the market it is nevertheless an area of
unmet clinical need. PowderMed are
developing a therapeutic vaccine in collaboration with GlaxoSmithkline to target
HIV and recently initiated a Phase I trial in patients with HIV. Northbank
Communications Ltd Dr
Douglas Pretsell or Sue Charles Tel:
+44
(0)20 7886 8150 d.pretsell@northbankcommunications.com
s.charles@northbankcommunications.com
PowderMed
Ltd Dr
Clive Dix Tel:
+44 (0)1865
501 549
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