NicOx Announces Initiation Of First Phase 1 Study Of Investigational Nitric Oxide-Donating Agent In Hypertensive Patients By Merck & Co., Inc.

Posted by poster on July 20th, 2008 under Uncategorized Tags: ,  •  Comments Off

Buy cialis pills NicOx S.A.
(Eurolist: COX) announced that Merck & Co., Inc. has initiated the
first in a series of planned clinical studies, in mild to moderate
hypertensive patients, under the companies’ collaborative agreement to
develop new nitric oxide-donating antihypertensive agents using NicOx’
proprietary technology. Three drug candidates have now been selected from
the companies’ joint research program, of which two have completed initial
dose ranging studies in healthy volunteers under the exploratory clinical
study paradigm with encouraging results.
Merck plans to conduct a number of clinical studies in hypertensive
patients involving single and multiple ascending dosing, prior to the
selection of a compound to be advanced into phase 2. The most advanced
candidate is now being evaluated in the first of these studies, which is a
single ascending dose trial in mild to moderate hypertensive patients. The
main objectives of this study are to assess the efficacy, safety,
tolerability and pharmacokinetics of single ascending doses of this
candidate. Subsequent studies will assess multiple ascending doses.
"The initiation of this series of clinical studies in hypertensive
patients is a very important step towards delivering a new treatment
paradigm for hypertension, where the medical need remains significant,"
commented Jacques Djian M.D., NicOx’ Cardiometabolic Area Leader. "We
believe these drug candidates have considerable potential as improved
antihypertensive agents based on their nitric oxide-donating properties and
we hope they will deliver a major advance in antihypertensive treatment for
patients worldwide."
In July 2007, NicOx announced the initiation of the first in a series
of studies in healthy volunteers for the selected candidates (see press
release of July 16, 2007). Merck is responsible for funding and performing
the development of these compounds going forward.
To date, NicOx has received euro 19.2 million from Merck under this
agreement
. NicOx also stands to receive potential additional milestone
payments of euro 269 million and industry standard royalties on the sales
of products which result from the agreement. Furthermore, NicOx has the
option to co-promote resulting products, on a fee-for-detail basis, to
specialist physicians in the United States and certain major European
countries.
"We are delighted that less than one year after the first drug
candidate entered human testing, we now have three drug candidates
identified and that the first of these has started patient dosing," said
Michele Garufi, Chairman and CEO of NicOx. "We look forward to continued
rapid progress in our collaboration with Merck and to the future
introduction of a new anti-hypertensive class on the market."
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of NCEs in the therapeutic areas of inflammatory and
cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary
NCE and the first compound in the Cyclooxygenase Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase
3 clinical studies for the treatment of the signs and symptoms of
osteoarthritis, with final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide-donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, glaucoma
and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext
Paris Stock Exchange (Compartment B: Mid Caps).
This press release contains certain forward-looking statements.
Although the Company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially
from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the Document de
Reference filed with the AMF, which is available on the AMF website
() or on NicOx S.A.’s website
().
NicOx S.A.

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Single drug treatment a viable option to radiation for early testicular cancer

Posted by poster on July 19th, 2008 under Uncategorized  •  Comments Off

Men’s Health News
Buy viagra without prescription The results of research into early testicular cancer has found that a single chemotherapy treatment is just as effective as radiation therapy while much less toxic.
The researchers from St. Bartholomew’s Hospital in London have found that for men diagnosed with early-stage seminoma, one of the most common types of testicular cancer, a single dose of the chemotherapy drug carboplatin is an effective treatment.
The study leader Dr. Tim Oliver says testicular cancer is the most common cancer in men aged 15 to 45 years and surgery followed by radiation has been the usual treatment.
For the study, 573 patients with testicular cancer were randomly assigned to a single dose of carboplatin given over 1 hour on an outpatient basis while the other 904 were given daily radiotherapy over a 2 or 3 week period.
Dr. Oliver says 5 years later the rate of the cancer reappearing was similar in the two groups - 5 percent in the carboplatin arm and 4 percent in the radiation group.
With both groups the side effects were few but the patients treated with radiation experienced higher levels of moderate to severe lethargy 4 weeks after starting the treatment.
Dr. Oliver says with testicular cancer as with prostate cancer, personal preference regarding treatment is becoming a more important factor in determining what is best for the patient.
He says the study establishes that surgery followed by carboplatin chemotherapy is a safe new alternative for patients who have early-stage seminoma and want a treatment that lasts a shorter period of time.
The research was presented at the American Society of Clinical Oncology annual meeting in Chicago.
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Deep Brain Stimulation May Offer Hope For Select Patients With Treatment Resistant Major Depression

Posted by poster on July 19th, 2008 under Uncategorized Tags:  •  Comments Off

Researchers from the Cleveland Clinic, Brown University, and Massachusetts General Hospital will present results of a long-term outcome study that builds on previous promising research, which has shown that deep brain stimulation (DBS) is a potentially effective treatment option for people with treatment resistant major depression.
The World Health Organization rates major depression as the top cause of disability worldwide. While many patients with major depression find relief through a combination of psychotherapy and medication, some people are left severely disabled. Patients who are most resistant to medications, psychotherapies, and electroconvulsive therapy (ECT) have little hope of recovery, and suffer a heightened risk of suicide and mortality. Sadly, statistics show that the suicide rate in people with major depression is as high as 15 percent.
DBS surgery involves the placement of tiny implantable electrodes into specific parts of the brain that are functioning abnormally. These electrodes emit tiny pulses of electrical stimulation to block the abnormal activity in the brain, which causes a variety of symptoms such as pain, tremors, movement problems; as well as obsessions, moods and anxieties associated with psychiatric disorders. Buy generic levitra The success of DBS is dependent on the surgical team’s ability to precisely pinpoint the specific brain area for stimulation. The advantage of DBS is that it is reversible, nondestructive, and can be modified by adjustment of the stimulator settings after implantation.
Ali R. Rezai, MD, director of Cleveland Clinic’s Center for Neurological Restoration, and a multi-center team of investigators were inspired by the success of DBS in treating the tremors associated with Parkinson’s and movement disorders like dystonia and essential tremor. "Starting in 2001, we began treating patients with obsessive compulsive disorder (OCD) with promising outcomes. These findings resulted in the initiation of a subsequent trial for patients with severe and medication intractable major depression, starting in 2003," stated Dr. Rezai.
"The preliminary results of research undertaken between 2003 and 2005 indicated that bilateral DBS of the anterior limb of the internal capsule holds promise for the treatment of intractable major depression, which led to the more extensive research results being presented today," added Dr. Rezai.
The results of the current study, Deep Brain Stimulation for the Treatment of Depression: Long-Term Outcomes from a Prospective Multi-Center Trial, will be presented by Dr. Rezai, from 10:30 to 10:44 a.m. on Tuesday, April 29, 2008, during the 76th Annual Meeting of the American Association of Neurological Surgeons in Chicago. Co-authors are Linda Carpenter, MD, Darin Dougherty, MD, Emad Eskandar, MD, Gerhard Friehs, MD, Cynthia Kubu, PhD, Andre Machado, MD, PhD, Paul Malloy, PhD, Donald Malone, MD, Lawrence H. Price, MD, Steven Rasmussen, MD, Scott Rauch, MD, Stephen Salloway, MD, and Audrey Tyrka, MD, PhD. This multidisciplinary group consists of close collaboration between neurosurgeons, psychiatrists and psychologists from these institutions.
Fifteen chronic and severely depressed patients were enrolled in this study. These patients had failed multiple medication trials, as well as psychotherapy and electroconvulsive therapy (ECT). These highly intractable and often suicidal patients underwent bilateral DBS implantation in the ventral internal capsule/ventral striatum (VC/VS) at the three institutions.
The Montgomery-Asberg Depression Rating Scale (MADRAS) was the primary outcome scale, among many scales, including those assessing overall quality of life, functioning and cognitive status. The outcome raters were blinded to the DBS status of the patient. Follow-up ranged from six to 48 months, with a duration of one year or longer in 11 of the 15 patients. Responder criteria was defined by this study as a 50 percent decrease in MADRAS scores. The following outcomes were noted:
– Responses were seen in seven (47 percent) of 15 patients at six months, five (45.5 percent) of 11 at 12 months, and eight (53.3 percent) of 15 at last follow-up.
– Long-term improvement in depression severity, functioning, and quality of life were all noted.
– Measures of short-term memory improved.
– There were no hemorrhages, infections or other neurological deficits.
"This research substantiates our earlier findings, which indicate that bilateral DBS of the anterior limb of the internal capsule holds promise and hope for select patients suffering from severe and treatment resistant major depression, stated Dr. Rezai. "While about half of this patient group responded to treatment, I feel that as we learn more about this rather new technology, efficacy will continue to improve. It is important to understand that this treatment is not for everyone with major depression and only for those that have tried various medications, psychotherapy and ECT. But, nevertheless, it is very promising news for the many suffering patients and their family members that have virtually given up hope."
Results of the OCD study, Deep Brain Stimulation of the Ventral Internal Capsule/Ventral Striatum for Obsessive-Compulsive Disorder (OCD): World-Wide Experience, will be presented by Dr. Rezai, one day prior to the depression study, 2:45 to 2:59 p.m., Monday, April 28. While OCD is not as prevalent as depression, it does affect 2 to 3 percent of the United States population, and at least 10 percent of patients have disabling cases that are resistant to treatment. The results reveal meaningful symptom reductions and functional improvement in about two-thirds of highly resistant patients after open treatment. Recent improvements in outcomes have been achieved through refinements in targeting areas. This is a worldwide cooperative prospective study involving the largest number of severe and intractable OCD patients with long-term follow-up with DBS.
Founded in 1931 as the Harvey Cushing Society, the American Association of Neurological Surgeons (AANS) is a scientific and educational association with more than 7,200 members worldwide. The AANS is dedicated to advancing the specialty of neurological surgery in order to provide the highest quality of neurosurgical care to the public. All active members of the AANS are certified by the American Board of Neurological Surgery, the Royal College of Physicians and Surgeons (Neurosurgery) of Canada or the Mexican Council of Neurological Surgery, AC. Neurological surgery is the medical specialty concerned with the prevention, diagnosis, treatment and rehabilitation of disorders that affect the entire nervous system, including the spinal column, spinal cord, brain and peripheral nerves.
American Association of Neurological Surgeons (AANS)
5550 Meadowbrook Dr.
Rolling Meadows, IL 60008
United States

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Five Million Hay Fever Sufferers Putting Health At Risk, UK

Posted by poster on July 19th, 2008 under Uncategorized Tags: ,  •  Comments Off

Over five million of the 13 million hay fever sufferers across Britain could be taking
inappropriate medicines, putting their health at risk. The Royal Pharmaceutical Society of
(RPSGB) is encouraging people experiencing the symptoms of hay fever to visit
their community pharmacist after new research revealed that the public often misdiagnose the
condition and fail to get the correct treatment.
Allergic rhinitis, known as hay fever, is a condition which is caused by the pollen of specific
seasonal plants, airborne chemicals and dust particles. It is commonly characterised by the
symptoms of sneezing, runny nose and itching eyes*.
A survey, commissioned by the RPSGB, found that a staggering 73% of people who
experience these symptoms fail to seek medical advice before selecting a treatment.
Moreover, the research reveals the damaging effects hay fever can have on sufferers’ quality
of life. The research finds that almost 40% of hay fever sufferers become irritable, and a third
experience difficultly sleeping. Worryingly, 29% have difficultly concentrating and 14% said
their symptoms affected their ability to read - findings which could have significant implications
for
school children and students, particularly as the hay fever season clashes with exam time.
More than one in 10 said they are embarrassed about their appearance and avoid socialising,
while one in 20 hay fever sufferers say they avoid leaving the home because of their condition.
David Pruce, RPSGB Director of Practice & Quality Improvement, says:
"The survey results clearly demonstrate the impacts a condition like hay fever can have on
peoples’ lives, with millions suffering unnecessarily. Pharmacists are highly trained health
professionals and experts in medicines - they can play a significant role in the management of
allergies including hay fever.
"Generic viagra pills no prescription The numbers of people failing to seek advice about their symptoms is surprising. There is a
large choice of anti-allergy products available and pharmacists are well placed to advise on
what
is best for the individual. Pharmacists can help people recognise symptoms, identify
allergy triggers and select appropriate products. Pharmacists can also suggest life-style
changes that may bring relief from hay fever and advise patients about potential side-effects of
the medicines they may be taking.
"Pharmacies are situated in the places where people live, work and shop and are open at
convenient times without the need to make an appointment."
Notes
Hay Fever
Allergic rhinitis, known as hay fever, is a condition which is caused by the pollen of specific
seasonal plants, airborne chemicals and dust particles, which only occur at certain times of the
year, in people who are allergic to these substances. Cells on the lining of the nose and eyes
release histamine and other chemicals when they come in contact with pollen. This causes
inflammation in the nose (rhinitis) and eyes (conjunctivitis). Hay fever is commonly
characterised by sneezing, runny nose and itching eyes.
*Hay fever symptoms are wide-ranging. They can include the following:
- itching of the nose, mouth, eyes, throat, skin, or any area exposed to the allergen
- runny nose
- watering eyes and/or plugged up ear canals.
- sneezing
- impaired smell
- nasal congestion
- sore throat
- wheezing
- conjunctivitis
- fever
- coughing
- headache
- fatigue
- irritability
The Royal Pharmaceutical Society of Great Britain
The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional and regulatory
body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians
on a voluntary basis, which is expected to become statutory under anticipated legislation. The
primary objectives of the Society are to lead, regulate, develop and represent the profession of
- pharmacy.
Research
Research was carried out by YouGov between 02-04 April 2008, interviewing 1981 people
including 547 hay fever sufferers. The GB population of adults 18+ is (according to ONS)
46,158,100. Therefore the number of hay fever sufferers in Great Britain aged 18 years of age
and above (27.59%) is 12,735,019. Of these, 41.95% agreed that they may have
misdiagnosed their condition, which equates to 5,342,340.
Full research results are available on request.
The Royal Pharmaceutical Society of Great Britain
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Depression And Primary Care - Expanding The Evidence Base For Diagnosis And Treatment

Posted by poster on July 18th, 2008 under Uncategorized Tags:  •  Comments Off

Primary care has the lead role in easing the burden of common mental disorders in Australia, according to an editorial in the supplement to the latest issue of the Medical Journal of Australia.
The MJA’s 48-page supplement, funded by a grant from beyondblue: the national depression initiative, adds to the evidence base needed to achieve it.
Professor Harvey Whiteford, from the Queensland Centre for Mental Health Research at the University of Queensland, says specialist mental health services play a supporting but not a central role in reducing mental health problems in Australia.
"A longstanding concern has been whether GPs are able to detect common mental disorders in their patients," he said.
"[In this supplement, researchers have] examined the way distress and depression are perceived by GPs ??¦ and [others] discuss the value of screening tools to increase recognition of patients with mental disorders."
The National Survey of Mental Health and Wellbeing, conducted by the Australian Bureau of Statistics in 1997, and the Australian Burden of Disease Study, conducted by the Australian Institute of Health and Welfare in 1998-99, greatly influenced mental health policy in Australia.
Professor Whiteford says that, until that time, the major focus of the National Mental Health Strategy had been on providing services for those individuals discharged from psychiatric hospitals.
"Buy viagra without prescription While the service reforms for such individuals remain incomplete, the information provided by the ABS and AIHW studies significantly expanded the mental health policy agenda.
"Ensuring the primary mental health care sector can reduce the burden of common mental disorders by increasing the number of patients receiving evidence-based interventions remains the challenge."
Even when common mental health problems such as depression are detected and treated, there is still a need to address relapse prevention. The supplement includes a report of a depression relapse prevention program that was trialled with some success in South Australia.
Professor Whiteford says primary care is an ideal setting in which to address the high co-morbidity between mental and physical disorders.
"This emphasises the importance of integrated clinical care for these people," he said.
The Medical Journal of Australia is a publication of the Australian Medical Association.
Medical Journal of Australia
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