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26
October 2004
Prasugrel v. Plavix trial - antiplatelet agents
A
Phase 3 clinical trial will begin later this year to compare the effects
of prasugrel (CS-747), an investigational antiplatelet agent, with
the antiplatelet market leader Plavix(R), in
patients undergoing a procedure to
open clogged arteries.
The study, TRITON-TIMI 38, will include 13,000 patients worldwide with
acute coronary syndrome (heart attacks
and/or unstable angina), who are to undergo
percutaneous coronary intervention (PCI), a procedure to open a clogged
heart artery. Approximately 850 hospitals in 25 countries are targeted
for participation in this study.
Prasugrel is being developed by Eli Lilly and Company (NYSE: LLY) and
Sankyo Company, Ltd. (TSE: 4501) for the
treatment of patients who have suffered
a heart attack or heart-related chest pain.
The primary focus of the study is to compare the agents' ability to
prevent heart attack, stroke and death in
patients who undergo PCI. The secondary
focus will be to look at the impact on bleeding, recurrent heart-related
chest pain (ischemia) or the need for additional procedures to restore
blood flow (urgent target revascularization).
About Prasugrel (CS-747)
Prasugrel is an investigational oral antiplatelet agent designed to
prevent platelet activation by blocking
adenosine diphosphate receptors on the
platelet surface. The novel oral compound was discovered by Sankyo and
Ube industries, Ltd. (TSE:4208). It is being
investigated for the treatment of
patients with acute coronary syndrome who undergo percutaneous coronary
intervention.
22
October, 2004
‘Casodex’
(bicalutamide) 150mg
Men
with locally advanced prostate cancer gain “important clinical
benefit” from treatment with a 150mg dose of bicalutamide, according
to three key papers in two international journals published this month.1,
2, 3 Clinical papers published in the British Journal of
Urology (international) and the Journal of Urology present
physicians globally with the challenge of incorporating these new
findings into their clinical practice so that more men can benefit from
this approach.
The
SPCG-6 study, involving 1,218 patients in 62 centres, is being conducted
in
Denmark
,
Finland
,
Norway
and
Sweden
and is one
of the three ongoing clinical trials in the EPC Trial Programme, the
largest randomised treatment programme of
studies conducted in prostate cancer, involving 8,113 men
aged 38 to 93 years, in 23 countries. The
most recent analysis of the SPCG-6 study shows that while the survival
benefits of bicalutamide 150mg are dependent on the disease stage, there
are significant improvements in progression-free survival for patients
with locally advanced prostate cancer – by as much as 60%.1
The
second and third pieces – the overall
EPC 2nd analysis manuscript in the Journal of Urology
by Professor Manfred
Wirth from the Department of Urology at the Technical University of
Dresden Medical School, Germany and
a commentary on the results of the EPC programme in the British
Journal of Urology (international) by leading urologist Mr John
Anderson
from the
Royal
Hallamshire
Hospital
,
Sheffield
,
UK
– further
support the role of bicalutamide 150mg
for the management of locally advanced prostate cancer.2,3
Based
on recent data from the EPC Trial Programme, Mr Anderson
concludes that the greatest progression-free survival benefit is seen in
patients with locally advanced disease taking bicalutamide 150mg.3 Because
this group is at significant risk of disease progression, “any
additional therapies that can reduce this risk, with minimal effects on
lifestyle, are important,” he adds.3
The EPC programme is the largest
prostate cancer treatment study to date including over 8,000 patients
from 23 countries around the world
References:
1 Iversen,
P. SPCG-6 study update: bicalutamide 150mg in early non-metastatic
prostate cancer. J Urol. 2004; 172: 1871–1876
2.
Wirth M et al.
Bicalutamide (Casodex) 150mg as adjuvant to radical prostatectomy
significantly increases progression-free survival in patients with early
non-metastatic prostate cancer: analysis at a median follow-up of 5.4
years. J Urol. 2004; 172: 1865–1870
3.
Anderson
, J. Bicalutamide 150mg: Practical Prescribing in Patients with Early
Prostate Cancer. Br J Urol Int. 2004; 94: 758–759
4 Bicalutamide
(Casodex) 150 mg. Summary of
Product Characteristics
5
England
: Office for
National Statistics (ONS) from data supplied by the regional cancer
registries in
England
.
Scotland
: Information and
Statistics Division of the Directorate of Information Services NHS in
Scotland
.
Wales
: Welsh Cancer
Intelligence and Surveillance Unit.
Northern Ireland
:
Northern Ireland
cancer Registry
.
4
October, 2004
Lice attack
- non--toxic headlice treatment
Clinical trials at
Bristol
University
and in the
US
indicate highly successful
head lice infestation control with the use of
a new, non toxic , coconut oil
formula called "Lice
Attack". Its
development appears
especially relevant in the face of
widespread resistance in head lice to
some over-the-counter pediculocides,
some of which can cause inflammation of the skin and wheezing.
The
treatment is applied three times in
two weeks to break the life cycle of the
parasites.
UK
suppliers are Manx
Healthcare. For more
information on the product go to
_http://www.liceattack.com/_
To
view an abstract from British Journal of Dermatology
(2002 146:88-93) on
insecticide resistance in
head lice to over-the-counter
pediculocides, go to
_http://www.blackwell-synergy.com/links/doi/10.1046/j.1365-2133.2002.04473.x/abs/_
(http://www.blackwell-synergy.com/links/doi/10.1046/j.1365-2133.2002.04473.x/abs/)
Pfizer Oncology to Market
Campto® in the UK for Advanced Colorectal Cancer
London, October 1st, 2004 - Pfizer announced today that it has
successfully completed the acquisition of rights to all assets relating
to Campto® (irinotecan hydrochloride injection), a chemotherapy agent
for treatment of advanced colorectal cancer, formerly held by Aventis,
under the licence granted by Yakult Honsha Co., Ltd., Tokyo, Japan.
Campto® is one of the most widely studied chemotherapy agents in
colorectal cancer and additional tumor types. Pfizer will
assume responsibility for all clinical studies of Campto® initiated by
Aventis now underway.
Campto® is indicated for the treatment of patients with advanced
colorectal cancer in combination with 5-flourouracil and folinic acid in
patients without prior chemotherapy for advanced disease, and as a
single agent in patients who have failed an established 5-flourouracil
containing treatment regimen.
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Avodart
(dutasteride) as a treatment for benign prostatic
hyperplasia (BPH).
The
results show that long-term use of Avodart over four years
provides a significant improvement in symptoms, reduction in
the risk of BPH disease progression, reduction in prostate
volume and improvement in urinary flow. 1
The clinical paper outlines
how Avodart provides
a sustained reduction in total prostate volume over four
years, with an overall reduction of 27%. Improvements are
seen from as early as three months in some patients, and six
months in the majority of patients. A 6.5 point improvement
in symptoms on the AUA-SI scale was seen at four years.
Improvements
in urinary flow are seen from as early as one month, with a
2.7ml/sec Qmax improvement at four years.
Furthermore Avodart provides a reduction in the risk
of acute urinary retention (AUR) and BPH-related surgery of
57% and 48% respectively at two years and these incidence
rates were consistent in the two year open-label phase.
The study confirmed that Avodart is well-tolerated over a
four year period. A general trend towards a reduced
incidence of sexual dysfunction was also observed with
Avodart.
The
four-year clinical data on Avodart were pooled from three
randomised, placebo-controlled two-year studies involving
over 4,000 patients, and a further two-year extension to
these studies, in which all patients received Avodart 0.5mg
daily.1 More
than 2,000 patients completed the four-year study.
The progression of BPH is associated with a deterioration in
symptoms and urinary flow, an increase in prostate volume,
and an increase in the risk of long-term complications such
as acute urinary retention (AUR) and BPH-related surgery.2
A recent survey showed that three-quarters
of patients would prefer a drug treatment that provides a
50% reduction in the risk of BPH-related surgery and
requires up to six months for symptom relief, compared to a
drug treatment that provides symptom relief after two weeks
but does not reduce the risk of surgery
.3
Avodart
is the only 5-alpha-reductase inhibitor (5-ARI) that at
therapeutic doses inhibits both the type 1 and 2 isoenzymes
of 5-alpha-reductase, the enzyme responsible for converting
testosterone to dihydrotestosterone (DHT) in the prostate
and other tissues. DHT
is the primary cause of prostate growth and has been proven
to play a key role in the development and progression of BPH.
Avodart results in rapid and consistent suppression
of DHT that is maintained at four years.1
References
1.
Debruyne F,
Barkin J, van Erps P, Reis M, Tammela TLJ and Roehrborn C.
Long-term
treatment with the dual 5-alpha-reductase inhibitor
dutasteride results in continuous improvements in symptoms
and peak urinary flow in men with symptomatic benign
prostatic hyperplasia. Eur Urol 2004;
in press.
2.
Emberton M,
Andriole GL, de la Rosette J, Djavan B, Hoefner K, Navarrete
RV, Nordling J, Roehrborn C, Schulman C, Teillac P, Tubaro A
and Nickel JC.
Benign
Prostatic Hyperplasia: a progressive disease of ageing men.
Urology
2003; 61: 267-273.
3.PROBE
survey. GSK data on file.
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27
September 2004
Flexibot: REVOLOUTIONARY ROBOT PITCHED AT INDUSTRIAL PARTNERS
Staffordshire
University
has teamed up with a firm of intellectual property developers to help
put a revolutionary robotic concept to commercial use.
The
groundbreaking Flexibot robotic arm has been developed by a specialist team based
at
Staffordshire
University
.
The
prototype Flexibot is “one step beyond” the current state-of-the-art
in robotics and offers its users the opportunity to tailor development
to meet their own specific requirements.
The
robotic arm is special because it can propel itself by travelling along
a series of docking stations, reaching from one fixed station to
another; or it can lock itself to a vehicle or another host.
Flexibot
is able to travel with precise accuracy and operate with infinite
degrees of movement, however extensive or diverse the environment is.
This unique design offers complete flexibility and the device is capable
of completing high precision tasks using a variety of instruments on its
own or with other robots.
Staffordshire
University
has appointed
Davidsons , a leading
London-based intellectual property consultancy to manage the process of
taking the invention to the next stage of its commercial development.
There
is a dedicated website (
www.robotic-arm.com
)
which gives interested parties further information and allows them to
communicate directly and confidentiality with Davidsons.
For
copies of a
Flexibot CD contact: Davidsons
Intellectual Property Consultants
8
Southampton Place,
London
,
WC1A 2EA
,
UK
.
Tel: +44 (0)
20 7404 5800 Fax: +44 (0) 20 7404 5801
22
September, 2004
"Care Notes" - STRAND
Technology,
CareNotes, is a highly-sophisticated software solution which allows
hospitals and NHS Trusts to keep patient records electronically, on
computer.
The CareNotes solution has the
capability to revolutionise the way patient records are used within the
health service and is already being used by 14 NHS Trusts across the
country.
CareNotes can store a complete patient history, with built in security
levels to ensure patient confidentiality. It can also be used to set up
individual patient care plans involving care teams in hospitals and
staff working in the community – saving both time and money for NHS
Trusts.
David Hannam, Sales Director for
Strand
, said: “All our software is developed in consultation with the people
who use it, this ensures it is exactly what they need – we believe
that has been the key to developing such a successful product.
For more details visit www.strandtechnology.co.uk
15
September, 2004
Yentreve(R)
(duloxetine hydrochloride)
First
and Only Widely Approved Pharmaceutical Option for the Treatment of
Stress Urinary Incontinence
. Women in European countries now have hope to overcome this
debilitating
medical
condition
SUI, the most common form of urinary incontinence in women, affects one
in
seven women and is the accidental leakage of urine during physical
activities
such as sneezing, coughing, laughing, lifting or exercise.
The European Commission granted marketing authorization for Yentreve(R)
based on
ten
studies across five continents involving more than 2,000 women with SUI.
The
studies demonstrated that Yentreve(R) reduces the number of leakages by
50
to 100% in more than half of women with SUI, improves their quality of
life
and is generally well tolerated with mild and manageable side effects,
the
most common of which is transient nausea.
Yentreve(R) for the Treatment of SUI
Studies show that Yentreve(R) is a balanced dual reuptake inhibitor of
the
neurotransmitters serotonin and norepinephrine,(9) neurotransmitters
that
are
believed to play key roles in the normal closure of the urethral
sphincter,
the muscle that -- if weakened -- can cause SUI.(9,10) By
increasing
neurotransmitter concentration, Yentreve(R) is believed to
increase
the tone and contraction of the urethral sphincter, which helps
prevent
accidental urine leakage during physical activities such as sneezing,
coughing,
laughing, lifting or exercising.
The
side effect profile of Yentreve is consistent with that seen with
other
drugs that have an impact on serotonin and norepinephrine. The most
commonly
reported adverse event was nausea, although it was usually mild to
moderate
and resolved within one week to one month in most patients. Other
less
prevalent adverse events included headache, insomnia, constipation, dry
mouth,
dizziness, and fatigue,(11) which tended to be non-progressive and
mild
to moderate in almost all patients.
Femara (letrozole)
Nearly Halves Risk of Breast Cancer Returning
For
the first time, a treatment option is available to postmenopausal
women
in the
UK
who have completed tamoxifen therapy for
early breast cancer.
Femara
has been shown to cut the risk of dying from breast cancer recurrence
by
39% in women with node positive disease (which has spread to nearby
lymph
nodes).
This new indication for Femara throws a lifeline to women as until now,
standard
treatment for many patients has been five years of tamoxifen therapy
following
their surgery. However, one third of women with breast cancer will
have
a relapse after surgery, and over half of these relapses occur once
standard
tamoxifen therapy has ceased. Experts agree that after five
years
of tamoxifen, the risks outweigh the benefits of continuing treatment.
The new indication follows exceptional results experienced by patients
participating
in the international breast cancer trial of nearly 5,200 women,
the
MA-17 study. The study set out to examine the effectiveness of
Femara
(an aromatase inhibitor drug), following five years of treatment with
tamoxifen.
This is the period where women are not normally treated despite
the
ongoing risk of breast cancer recurrence.
The unprecedented results led the investigators to unblind the trial
early
and recommend that postmenopausal women who have been treated with
tamoxifen
for five years should be considered for treatment with Femara. The
results
showed that taking Femara after five years of tamoxifen reduces the
risk
of breast cancer recurring by 42 per cent; reduces the risk of
breast
cancer spreading to another part of the body by 39 per cent; and
improves
survival, reducing the ongoing risk of dying from breast cancer by
39
per cent in women whose cancer had spread to the lymph nodes at
diagnosis
.
Taking Femara after five years of tamoxifen may lead to a small
increased
risk of osteoporosis. To build on the results of this landmark
trial,
patients in the trial are still being monitored.
Femara, an oral once-a-day therapy, is now licensed in the
UK
for
treatment
of early invasive breast cancer in postmenopausal women who have
received
prior standard adjuvant tamoxifen therapy.
It is also licensed for:
- the first-line treatment of hormone receptor positive or hormone
receptor
unknown locally advanced breast cancer in postmenopausal women and
is
proven to be superior to tamoxifen as first-line therapy in advanced
disease;
- the treatment of advanced breast cancer in postmenopausal women with
disease
progression following antioestrogen therapy;
- preoperative (neoadjuvant) therapy. Femara is the only drug of its
class
to hold a licence within the
UK
to treat breast tumours on a
preoperative
basis in hormone receptor positive patients.
2
September, 2004
Yamanouchi
Announces the Launch of Vesicare®
Yamanouchi,
today announced the launch of new Vesicare® (solifenacin
succinate), the only once-daily bladder-selective antimuscarinic agent
proven to provide a statistically significant improvement across all
symptoms of OAB syndrome, including frequency, urgency, incontinence and
nocturia[i].
Clinical
efficacy
Vesicare®
has been evaluated in four multiple randomised placebo-controlled trials
involving over 3700 patients with OAB syndrome, which have shown that
Vesicare® is effective in the treatment of all symptoms of
OAB[ii].
Urgency is now accepted as the most troublesome component of OAB
for the patient. Urgency has more quality of life impact on the OAB
sufferer than any other symptom. Vesicare®
is the first antimuscarinic agent to report consistent and statistically
significant reductions in quantified episodes of urgency across
multiple, placebo-controlled clinical trials.
The consistent and broad efficacy reported with Vesicare®
treatment against symptoms of OAB, including urgency, support its
therapeutic potential. [iii]
After 12 weeks' treatment, urgency episodes were reduced by 66% at a
dose of 5 mg/day and 70% at 10 mg/day and, after one year, a median 100%
of incontinent patients became continent[iv].
Vesicare® also reduces the number of micturitions per 24
hours for both the 5 and 10 mg doses (by 19% and 23% respectively) and
nocturia (36% and 36%).[v]
Tolerability
In clinical trials Vesicare® was found to be very
well tolerated. The most common adverse events were dose-related dry
mouth, constipation and blurred vision. In clinical trials, 89% of
patients taking the 5 mg/day dose did not experience dry mouth[vi].
A recent
large study that included interviews with over 2000 people in the
UK
indicated
that 19% of the population have OAB syndrome[ix].
Estimates of the incidence of common conditions vary across
Europe
.
The approximate figures for the
UK
, quoted in
the Department of Health National Service Framework are Asthma 7%[x],
Angina 2%[xi]
and Diabetes 2%11.
Prevalence
data shows that:
-
Overall,
16.6% of the population aged over 40 years in six European countries
have symptoms of OAB.
-
It
is estimated that 49 million people in
Europe
aged over 40 suffer from OAB9.
-
44
million out of 49 million OAB sufferers in
Europe
are currently not being treated.
Affects
about 1/6 adults over 40 yrs in
Europe
and the
US
[xii].
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