One of the major issues associated with longer life expectancy in man and his best friend is an increase in the incidence of cancer. Even though they cannot talk it seems dogs might be able to tell us why and how certain cancers develop. In turn that could lead to better treatments for both canine and human cancer patients.

An expert from the country’s newest Vet School told a symposium in London that studying tumours in dogs and humans could give us a better understanding of their shared pathogenesis.

Dr Ali Mobasheri, an Associate Professor from the School of Veterinary Medicine and Science at The University of Nottingham, attended the one day symposium entitled “Curing Canine Cancer — Human Cancer Benefit”. The symposium was organised by the Colorado based Morris Animal Foundation and is the first event of its kind to be held in this country. As well as addressing the cause of canine cancer, it will explore areas of translational cancer treatment research as cancer cures for dogs are now being successfully applied to humans, in particular children.

Cancer is the single biggest cause of death in dogs over the age of 2. The incidence of bone cancers, skin cancers, and lymphomas is increasing in humans and dogs and there are significant similarities between certain types of human and canine cancer — such as breast and prostate cancer. Dr Mobasheri says we are all mammals with similar genes and studying the bioenergetics of canine tumours will allow us to gain a comparative understanding of human tumour metabolism. He said: “We are using high throughput screening techniques to identify new biomarkers of prognostic significance in cancer. The approach involves using clinical samples from a tissue bank to carry out hypothesis driven immunohistochemical studies to look at tumour metabolism.”

Certain breeds of dog are known to develop certain types of cancer. For instance Osteosarcoma (bone cancer) is common in the Greyhound and the Rottweiler. It is also the sixth most common cancer seen in children. Research into canine cancer is easier because of the dog’s extensive pedigree information. Experts say this could be crucial in identifying the underlying genetic causes of cancer in dogs and humans and finding treatments that could be to the benefit of both.

Dr Mobasheri said: “The benefits of taking a comparative approach to cancer research will be of mutual benefit to humans and companion animals. That is because cancer is cancer. It is a similar disease in animals and humans.”

The University of Nottingham is Britain’s University of the Year (The Times Higher Awards 2006). It undertakes world-changing research, provides innovative teaching and a student experience of the highest quality. Ranked by Newsweek in the world’s Top 75 universities, its academics have won two Nobel Prizes since 2003. The University is an international institution with campuses in the United Kingdom, Malaysia and China.

Additional information can be found at morrisanimalfoundation/

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If you clean your house vigorously for twenty minutes non-stop once a week, your anxiety, distress or depression may improve, according to a study published in the British Journal of Sports Medicine.

The study also stresses that any type of vigorous physical exercise, sustained for a 20-minute period can have a good impact on your mental health. The scientists, from University College London, say that the more vigorous and frequent the activity, the greater the impact.

The study examined a survey of 20,000 men and women who were quizzed for the Scottish Health Survey about their state of mind and how much weekly physical activity they engaged in. Over 3,000 participants were deemed to be suffering from stress and/or anxiety. They found that people who did sports at least once a week were 33% less likely to suffer from mental health problems. Those who did vigorous housework once a week regularly were 20% less likely to suffer from mental health problems. This drop in risk held even after taking into account such factors as age, gender, and the presence of a long term condition.

The researchers stressed that vigorous housework does not include some little light dusting. As well as lasting at least 20 minutes, the activity has to make you feel at least slightly breathless.

The scientists explain that physical activity reduces inflammation, glucose intolerance and cardiovascular problems, all biological factors which are linked to depression risk. They believe these biological factors are probably key to helping physically active people enjoy better mental health. On the other hand, they accepted that it is possible it might be the other way round – people with mental health problems perhaps do not exercise as much.

Mark Hamer, University College London, research team member, explained that several studies seemed to show a link between better mental health and physical activity. This is the first study that quantifies the amount of activity needed to have an impact. He added “But it is a chicken and egg issue – as those who suffer from stress or anxiety may be less likely to take part in physical activity in the first place.”

“Dose-response relationship between physical activity and mental health: the Scottish Health Survey.”
Online First Br J Sports Med 2008; doi 10.1136/bjsm.2008.046243
Click here to view abstract online

Written by – Christian

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Today, The Lancet Neurology published positive results from a sub-group analysis of the landmark Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY®) trial – the largest atrial fibrillation (AF) outcomes trial ever completed (18,113 patients in 44 countries worldwide). The new findings fully support the convincing results from the
RE-LY® trial and show that AF patients with previous stroke or transient ischemic attack (TIA) may benefit substantially from treatment with dabigatran etexilate.1,2,3

The new sub-group analysis from RE-LY® included 3,623 AF patients who had suffered a stroke or TIA before enrolment into the trial. The results of the sub-group analysis were consistent with the overall trial results for the major efficacy and safety outcomes. This was confirmed by an interaction analysis which showed that results in patients with previous stroke or TIA were consistent with the overall results found in the RE-LY® trial.1,2,3

The 150 mg dose of dabigatran etexilate provided a substantial 25% reduction in relative risk compared with well controlled warfarin in the combined endpoint of stroke and systemic embolism in the sub-group of patients with previous stroke or TIA in line with the results of the main RE-LY® trial. However, due to the five fold smaller sample size of this subpopulation compared to RE-LY®, this difference did not reach statistical significance. Impressively, both doses (110 mg BID and 150 mg BID) also demonstrated significant reductions in intracranial bleeds versus well controlled warfarin.1 These findings support the overall striking results of RE-LY® in the prevention of stroke and systemic embolism of dabigatran etexilate,2,3 within a patient sub-group who are at 2.5 times increased risk compared with a typical AF patient without previous stroke or TIA, who themselves are already at 5-times increased risk.4,5,6

Based on the convincing results of RE-LY®, dabigatran etexilate was approved in the USA for stroke risk reduction in patients with non-valvular AF and in Canada for the prevention of stroke and systemic embolism in patients with AF for whom anticoagulation is appropriate.7,8

New data from the RE-LY® trial and dabigatran etexilate will be available at this year’s American Heart Association Scientific Sessions 2010, Chicago, U.S, 13-17 November.

Notes

About RE-LY®

RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, randomised trial of 18,113 patients enrolled in over 900 centres in 44 countries, investigating whether dabigatran etexilate (2 blinded doses) is as effective as well controlled warfarin with target INR of 2.0-3.0 for stroke prevention. Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.

The primary endpoint of the trial was incidence of stroke (including haemorrhagic) or systemic embolism. Secondary outcome measures included all-cause death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).

Compared to well controlled warfarin, dabigatran etexilate showed in the trial:2,3

– Significant reduction in the risk of stroke and systemic embolism – including haemorrhagic strokes with dabigatran etexilate 150 mg bid

– Significantly lower major bleeding events with dabigatran etexilate 110 mg bid

– Significantly lower life threatening and intracranial bleeding with both doses

– Significant reduction in vascular mortality with dabigatran etexilate 150 mg bid.

About AF and stroke

AF is the most common heart rhythm condition, affecting around 1% of the total population, rising to 10% in people over the age of 80.9 People with AF are at increased risk of blood clots, which raises stroke risk by five times.7,8 Up to three million people worldwide suffer strokes related to AF each year,10-13 which tend to be especially severe and disabling, with half of people dying within one year.13A total of 6.3 million people in the US, Japan, Germany, Italy, France, UK and Spain were living with AF in 2007 and this is expected to increase to 7.5 million by 2017 primarily due to the ageing population.14 Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%), with resultant
societal costs and burden to the healthcare system.13 AF alone is associated with a cost of up to €13.5 billion across the European Union.4

Well-controlled vitamin K antagonist (VKA) therapy (warfarin), currently used for the prevention of stroke in atrial fibrillation, is highly effective in reducing the risk of stroke by approximately two-thirds,15 but is associated with an increased risk of bleeding as well as several limitations. Drug-drug and food interactions as well as the requirement for frequent monitoring result in only about 50% of eligible patients receiving VKA therapy16 with fewer than half of these controlled within the therapeutic INR range.17

About dabigatran etexilate

Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)18 targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast
to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

Dabigatran etexilate has already been approved in 75 countries under the trademark Pradaxa® (in Canada: Pradax®) for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.

Disclaimer

Dabigatran etexilate is only approved for clinical use in stroke risk reduction in non-valvular atrial fibrillation prevention in the US and the prevention of stroke, and systemic embolism in adults with atrial fibrillation in Canada. This information is provided for medical education purposes only.

About the dabigatran etexilate clinical trial programme

Boehringer Ingelheim’s clinical trial program to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:

– Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgeries

– Treatment of acute VTE

– Secondary prevention of VTE

– Secondary prevention of cardiac events in patients with acute coronary syndrome (ACS)

– Stroke prevention in atrial fibrillation (AF).

References

1. Diener HC. Dabigatran Compared with Warfarin in Patients with Atrial Fibrillation and Previous TIA or Stroke: a subgroup analysis of the RE-LY trial. Published online November 8, 2010, DOI:10.1016/S1474-4422(10)70274-X

2. Connolly SJ,et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361:1139-51.

3. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L: Newly identified Events in the RE-LY trial. N Engl J Med 2010;363:1875-1876.

4. Fuster V, Rydn LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006; 114:700-52.

5. Kannel WB, et al. Final Draft Status of the Epidemiology of Atrial Fibrillation. Med Clin North Am. 2008; 92(1): 17-ix.

6. Stroke in Atrial Fibrillation Working Group. Independent predictors of stroke in atrial fibrillation: a systematic review. Neurology 2007; 69: 546-54.

7. U.S. Food and Drug Administration – Pradaxa® Prescribing Information. Oct 19th, 2010.

8. Health Canada – PRADAX™ Prescribing Information. Oct 26th, 2010.

9. Stewart S, Murphy N, Walker A, et al. Cost of an Emerging Epidemic: an Economic Analysis of Atrial Fibrillation in the UK. Heart 2004; 90:286-92.

10. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed July 2009 here.

11. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991: 22(8);983-8.

12. Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischaemic stroke: results from a population-based study. Stroke 2005; 36:1115-9.

13. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996; 27:1760-4.

14. Benyoucef S, Hughes M, Mehta N. Atrial Fibrillation. Decision Resources, December 2008.

15. Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med 1999; 131:492-501.

16. Hylek EM, DAntonio J, Evans-Molina C, et al. Translating the results of randomized trials into clinical practice. The challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37:1075-80.

17. Samsa GP, Matchar DB, Goldstein LB, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities.Arch Intern Med 2000; 160:967-73.

18. Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J Med 2005; 353:1028-40.The European Atrial Fibrillation Trial Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 1993; 342:1255-1262.

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Medgenics (AIM: MEDG) (AIM: MEDU) is pleased to announce that the latest, encouraging results of the Company’s ongoing EPODURE Biopump Phase I/II Clinical Trial will be presented at the 45th Conference of the Israeli Society of Nephrology and Hypertension, in Israel on March 27, 2009.

The latest results of the trial show that in the first 2 of the patients treated, the hemoglobin level has now remained continuously in the target range of 10-12 g/dl for more than 5 months following a single EPODURE treatment using the lowest dose of 20 IU/kg/day, thus effectively treating their anemia without receiving any injections of erythropoietin (EPO) during this period. One of the patients received his last EPO injection more than 200 days ago. This is contrasted with the FDA approved standard regimen of thrice weekly EPO injections, in which typical patients would expect to receive up to 85 injections in this timeframe.

A total of 7 patients have now been treated, with 6 patients receiving treatment for more than one month. The seventh patient is the first to receive the higher dose of 40 IU/kg/day, which is double that of the lowest dosage, and the higher dose treatment is proceeding smoothly. There continue to be no adverse events reported in the study. Patient recruitment continues for the higher dose treatment.

The new data will be presented at the conference by Dr. Michal Dranitzki Elhalel, the principal nephrologist of Medgenics’ EPODURE Phase I/II clinical trial, currently taking place at the Hadassah Hebrew University Hospital in Jerusalem, Israel.

The trial’s sponsors and Principal Investigators are now seeking approval to broaden the study to include dialysis patients as well as pre-dialysis patients. More information on this will be announced as developments proceed.

The Company’s active discussions with major potential strategic partners have expanded since the announcement in February, with additional companies having expressed interest in one or more applications.

Notes

Medgenics, Inc. is a clinical-stage biopharmaceutical company developing its unique tissue-based Biopump platform technology to provide sustained-action protein therapy for the treatment of a range of chronic diseases.

Medgenics currently has two products in development based on this technology:

- EPODURE – producing erythropoietin (EPO) to treat anemia

- INFRADURE – producing interferon-alpha (IFN-?±) to treat Hepatitis-C

The Company’s ongoing Phase I/II clinical trial for EPODURE in anemic patients continues to demonstrate proof of concept of the Biopump. Designed to produce and deliver a therapeutic dose of EPO steadily for up to six months or more, EPODURE Biopumps are already maintaining effective anemia treatment for more than 5 months in earliest patients in the ongoing study, even with low dose administered.

Medgenics intends to develop its innovative products and bring them to market via multiple strategic partnerships with major pharmaceutical and/or medical device companies, starting with EPODURE and INFRADURE.

Medgenics plans to raise the requisite funds during 2009 to enable it to follow the current trial of EPODURE with a Phase IIb clinical trial in the US starting in 2010, and in addition, to commence a Phase I/II trial of INFRADURE in Hepatitis-C patients in Israel also during 2010.

Beyond these, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach US $87 billion by 2010. Other potential areas include multiple sclerosis (interferon-??), hemophilia (Factor VIII), pediatric growth hormone deficiency (human growth hormone) and diabetes (insulin).

Founded in 2000, Medgenics is a US-incorporated company with major operations in Misgav, Israel. Medgenics was admitted to the London AIM in December 2007 (AIM: MEDG and AIM: MEDU).

medgenics

Cautionary Notice Regarding Forward-Looking Statements

This release contains forward-looking statements, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, business strategy, plans and objectives of management for future operations. These statements relate to future events, prospects, developments and strategies. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

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Facilities should be properly regulated and patients properly informed before cosmetic procedures can be performed.

Chief Medical Officer Professor Sir Liam Donaldson today outlined a series of moves to ensure better training for doctors,
better information for patients and a tougher regulatory structure for private cosmetic surgery. Responding to the Expert
Group Report on the Regulation of Cosmetic Surgery and The Healthcare Commission’s ‘Provision of cosmetic surgery in England’
report launched today, the Chief Medical Officer said:

“Cosmetic procedures are a rapidly growing area of private healthcare. Many people spend their hard-earned money on these
services. Some are disappointed with the outcome but a minority can suffer serious harm or disfigurement. Standards in the
cosmetic treatment field must be as high as other areas of health care. We must ensure we properly protect patients’ safety
by improving the training, regulation and information provided.

“To ensure better training we will be asking the relevant professional bodies to develop specialist training programmes as a
matter of urgency for surgeons undertaking cosmetic surgery. Detailed, accredited advice and education materials will be made
available for patients and the public by the summer and we will also be working with the Healthcare Commission (the main
health regulator) to bring additional cosmetic procedures such as aesthetic fillers and botox facitlities within their
regulatory remit by the end of the year.

“People have to be confident that their treatment will be safe, that the medical practitioners who treat them are qualified
and competent, and that they have the information they need to make informed decisions. The action being announced today is
directed at addressing this.”

The Expert Group has found that, while there is no firm evidence of harm to patients under the current arrangements for
regulation of cosmetic surgery, this is a growing area with more people wanting to have procedures and new and different
procedures being developed all the time, which demands a more robust regulatory structure.

The Department has also committed to:

— Ensure the facilities where botulinum toxins are injected be licensed with the Healthcare Commission and therefore
subject to its regulations

– Ensure that all cosmetic surgeons and nurses provide to potential and actual patients details of their qualifications,
registration, membership of professional organisations, and other medical training and education

– Ensure current legislation and regulation governing the use of lasers – that every facility defined in the legislation
should be registered with the Healthcare Commission – are more consistently enforced. That laser procedures are overseen by a
doctor and conducted by appropriately trained and qualified practitioners

– Ensure that the General Medical Council improves the recording and classification of data about complaints so that
comparisons can be made between different medical specialties and procedures.

— Review the need and scope for additional regulation of aesthetic fillers and in particular any that contain human tissue.
The Medicines and Healthcare products Regulatory Agency will work with interested parties, including DTI, and will take into
account the likely emergence this year of proposals from the European Commission for the regulation of tissue engineered
products.

Sir John Temple, Chairman of the Cosmetic Surgery Inter-Specialty group, said:

“As chair of the inter speciality group we are pleased to have been able to contribute to this report and look forward to
being involved in future consultations and work.”

Harry Cayton, Director for Patients and Public, said:

“I believe that the recommendations in our report will help ensure that people can make informed choices before undergoing
consmetic surgery, and that they can be confident that cosmetic surgery and procedures are well regulated.”

Andrew Vallence-Owen, BUPA Group Medical Director said:

“Cosmetic surgery is one of the fastest growing segments of the private healthcare market and patients need to know that
their surgeon is not only fully qualified but highly trained and experienced and a specialist in their field. We must
establish proper training and accreditation in cosmetic surgery so I urge the profession to urgently address the
recommendations in this report.

“Procedures, for instance those using Botox, must be better regulated and we have to get tough with the cowboy operators. Low
standards, although only practised by a few, damage patients and give everyone working in this area a bad name.”

Related links

Chief Medical Officer

Health Care Commision

Notes to editor

1. A full copy of the Expert Group Report on the Regulation of Cosmetic Surgery and a list of responses to the
recommendations made can be found at the link provided:

2. Current regulations for cosmetic surgery are as follows:

Invasive cosmetic surgery is currently regulated by the Care Standards Act 2000. Responsibility of the Healthcare Commission
since April 2004

Laser treatment Practitioners are required to register with the Healthcare Commission. Regulated using Independent Healthcare
Standards P1-P3 of the Care Standards Act 2000.

Botulinum toxins injections The prescription of botulinum toxins is regulated and they should only be prescribed by a doctor
for a named patient. However, botulinum toxins are not licensed for cosmetic use and are therefore only used for this purpose
on an off-licence basis.

Aesthetic fillers The injection of cosmetic fillers is not currently regulated. The regulation of filler products is very
unclear. Some fillers are classified as drugs or medical devices and therefore are regulated by the Medical Healthcare
Products Regulatory Agency (MHRA). Those which contain human tissue are not classified as a medical device and are covered
under the General Product Safety Regulations 1994.

3. The Healthcare Commission’s ‘Provision of cosmetic surgery in England’ report can be found at the healthcare commission web site.

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Men who have too much calcium in their bloodstreams may have an increased risk of fatal prostate cancer, according to a new analysis from Wake Forest University School of Medicine and the University of Wisconsin.

“We show that men in upper range of the normal distribution of serum calcium subsequently have an almost three-fold increased risk for fatal prostate cancer,” said Gary G. Schwartz, Ph.D., associate professor of cancer biology and of epidemiology and prevention at Wake Forest, a part of Wake Forest University Baptist Medical Center. Such excess calcium can be lowered, he said.

The research appears in the September issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Co-author Halcyon G. Skinner of the School of Medicine and Public Health at the University of Wisconsin stressed there is “little relationship between calcium in the diet and calcium in serum. So men needn’t be concerned about reducing their ordinary dietary intakes of calcium.”

Schwartz and Skinner analyzed the results of 2,814 men who participated in the National Health and Nutrition Examination Survey (NHANES-1). Measurement of the amount of calcium in the bloodstreams was determined an average of 9.9 years before prostate cancer was diagnosed.

The researchers focused on the 85 cases of prostate cancer and 25 prostate cancer deaths among the 2,814 men and divided the group into thirds, based on the serum calcium level. “Comparing men in the top third with men in the bottom third, we found a significantly increased hazard for fatal prostate cancer.

“To our knowledge, this is the first study to examine prostate cancer risk in relation to serum calcium,” Schwartz and Skinner wrote. “These results support the hypothesis that high serum calcium, or a factor strongly associated with it, such as high serum parathyroid hormone, increases the risk for fatal prostate cancer.”

In an interview, Schwartz said that if the relationship between serum calcium and prostate cancer “turns out to be causal, it suggests a means for potentially reducing the risk of fatal disease through medicines that reduce serum levels of calcium and/or parathyroid hormone.”

He added, “Both calcium and parathyroid hormone are known to promote the growth of prostate cancer cells in the laboratory.”

Skinner said, “The take-home message is that this may offer a simple means to detect men who are at increased risk of fatal prostate cancer.”

Schwartz said serum calcium ordinarily is tightly regulated by parathyroid hormone, so there is little variation in an individual’s serum calcium over time. “Calcium is basically the current that runs many of the functions of your body. Calcium is important for not only neuromuscular conductions, electrical conductions, but for the conduction of muscles in your heart.”

Too little calcium in blood, less than 7 milligrams per deciliter, can cause uncontrolled muscular convulsions or contractions. Too much calcium, above 14 milligrams per deciliter, can cause a coma. “Your body obviously cannot afford to oscillate between convulsions and coma, so the range of serum calcium is tightly controlled.”

The upper third of NHANES-1 participants had high normal calcium levels, ranging from 9.9 to 10.5 milligrams per deciliter.

“If confirmed, our study shows that calcium at the high end of normal is associated with a three-fold increased risk of fatal prostate cancer later in life,” Schwartz said. But unlike well-known risk factors for prostate cancer such as age, race or family history, which cannot be altered, “a man’s serum calcium levels can be.”

Several drugs already used in patients with high levels of parathyroid hormone, such as patients with chronic kidney disease, could be used to reduce calcium and/or parathyroid hormone in the blood, he said.

Measurements of serum calcium are routinely collected and are part of most medical visits. Thus, a physician can readily determine whether a man’s serum calcium level is at the high end of normal.

“What is particularly exciting if this study is replicated, and attempts to do so are already in progress is that it suggests that a man may reduce his risk of fatal prostate cancer by lowering serum levels of calcium and/or parathyroid hormone,” he said.

Wake Forest University Baptist Medical Center (wfubmc) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children’s Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university’s School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of “America’s Best Hospitals” by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America’s Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.

Wake Forest University Baptist Medical Center
Medical Center Blvd.
Winston-Salem, NC 27157-1015
United States
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OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced that it has initiated a first-in-human clinical study for its G-protein coupled receptor GPR119 agonist, PSN821, which the Company is developing for the treatment of type 2 diabetes. Discovered by OSI’s diabetes and obesity research team, PSN821 demonstrated both effective glucose lowering and substantial reductions of body weight in pre-clinical studies. Pre-clinical data on PSN821 was the subject of an oral presentation at this year’s American Diabetes Association meeting in San Francisco, CA in June. PSN821 is the third development candidate discovered in-house that the Company has moved into clinical development this year. PSN602, OSI’s first anti-obesity agent to enter the clinic commenced a Phase I trial in June and OSI-027, the Company’s anti-cancer TORC1 and TORC2 inhibitor began a Phase I trial in July.

“We are encouraged by the dual profile which has been observed for PSN821 and believe that it has the potential to be the first orally available therapy for type 2 diabetes that delivers both glucose control and substantial weight loss,” stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. “PSN821 and our anti-obesity agent, PSN602, are part of an innovative strategy to discover and develop differentiated molecular targeted therapies for the treatment of type 2 diabetes and obesity.”

About the Study

The double-blind, placebo-controlled, ascending single oral dose study is designed to provide preliminary information on the safety, tolerability and pharmacokinetics of PSN821 in healthy lean and overweight/obese subjects and patients with type 2 diabetes, as well as provide preliminary information on the effects of PSN821 on acute glucose control in the patient group.

Background on PSN821

PSN821 is a novel, orally available agonist of the G-protein coupled receptor GPR119 which stimulates the release of both insulin and glucagon-like peptide-1 (GLP-1). In pre-clinical studies, PSN821 has demonstrated pronounced glucose lowering in rodent models of type 2 diabetes with no loss of efficacy on repeated administration, and substantial reductions of body weight in rodent models of obesity. In male diabetic ZDF rats, both acute and chronic oral administration of PSN821, significantly and dose-dependently reduced glucose excursions in an oral glucose tolerance test. In prediabetic male ZDF rats, daily oral dosing of PSN821 for 8 weeks significantly lowered nonfasting blood glucose concentrations and HbA1c levels compared to vehicle. Furthermore, in weight-stable, dietary-induced obese (DIO) female Wistar rats, daily oral dosing of PSN821 for 4 weeks reduced body weight substantially and significantly by 8.8%, approaching the 10.6% weight loss induced by a high dose of the prescribed anti-obesity agent sibutramine.

About OSI Pharmaceuticals

OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world. For additional information about OSI, please visit osip.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the results from, and the ability to complete, clinical trials, the FDA review process and other governmental regulation, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.

OSI Pharmaceuticals

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There will be a new drive to ensure GPs spot cervical cancer symptoms earlier in young women and refer patients correctly, Health Minister Ann Keen announced today.

The review, carried out by the independent Advisory Committee on Cervical Screening (ACCS) reported concern that young women who present to their GPs with cervical cancer symptoms are not always being given appropriate advice and have recommended immediate action in this area including:

- New guidance on the management of young women with gynaecological symptoms and an audit of young women diagnosed with cervical cancer.
- An awareness campaign for GPs and practice nurses.
- An audit of all young women diagnosed with cervical cancer looking at their symptoms prior to diagnosis.
- Expand work to increase screening uptake in women aged 25 to 34.

The ACCS also agreed unanimously for no change in the screening age as evidence showed that earlier screening could do more harm than good causing too many false positives and increase the risk of premature births in some women.

Health Minister Ann Keen said:

“In the past few months I have met with a number of young women who have cervical cancer. I have listened carefully and I am determined to make sure that our policy is in their best interests.

“That is why I asked the ACCS to carry out a review into the cervical screening age because I wanted to make sure that our guidelines are based on the latest available clinical evidence.

“They have concluded that the screening age should not be lowered but have recommended that we do more work around the treatment of symptomatic patients. I fully support this conclusion and look forward to beginning this important new work to ensure women with cervical cancer are diagnosed at the earliest possible opportunity.

“There has been a big public debate about this issue and a great deal of publicity about the causes and symptoms of cervical cancer. Together we can build on this work to help even more women across the country to take steps to prevent the disease and to identify symptoms early and save lives.”

ACCS Chairman Professor Henry Kitchener said:

“The Committee were unanimous in their decision not to lower the screening age below 25.

“This decision was taken because scientific evidence shows that screening women in this age group can do more harm than good.

“However we are concerned that young women with gynaecological symptoms are not always being given the right advice from their GPs and we will ask the Department of Health to take action.”

National Director for Cancer Professor Mike Richards said:

“The ACCS has done a very through job and I thank them for their work and fully agree with their recommendations.

“Importantly The ACCS has identified the need for urgent action on young women who present to their GPs with gynaecological symptoms. We know that early diagnosis is key to improving survival chances.

“We will develop guidance to support GPs and practice nurses so that young women with cervical cancer are diagnosed at the earliest opportunity.”

The ACCS will now consider ways to improve the way symptomatic patients are treated, with a particular focus on women under 25 and then make further recommendations to the Department of Health.

Source
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The National Institute for Health and Clinical Excellence (NICE) and the National Collaborating Centre for Mental Health have today (28 September) launched a clinical guideline on the treatment and management of depression in children and young people. The guideline recommends that -

• Children and young people with moderate to severe depression should be offered, as a first-line treatment, a specific psychological therapy (such as cognitive behavioural therapy, interpersonal therapy or family therapy of at least 3 months’ duration).

• Antidepressant medication should not be offered to children or young people with moderate to severe depression except in combination with a concurrent psychological therapy and should not be offered at all to children with mild depression.

• Healthcare professionals in primary care, schools and other relevant community settings should be trained to detect symptoms of depression, and to assess children and young people who may be at risk of depression.

• Attention should be paid to the possible need for parents’ own psychiatric problems (particularly depression) to be treated in parallel, if the child or young person’s mental health is to improve.

Andrew Dillon, Chief Executive of NICE and Executive Lead for this guideline says “This guideline makes it clear that psychological treatments are the most effective way to treat depression in children and young people. It’s important that children and young people taking anti-depressants do not stop taking them abruptly, but we would advise people to talk to their GP at their next regular review about whether a psychological treatment may be a more effective treatment option.”

Dr Tim Kendall, Joint Director of the National Collaborating Centre for Mental Health who developed the guideline on behalf of NICE says “This is the sixth mental health guideline where we have recommended psychological treatments as key treatments for a mental health condition and the third where we have recommended them as the first line treatment. The evidence supporting these treatments is robust and it is vital that the NHS provides psychological therapies to ensure everyone who needs these treatments can access them rapidly.”

Professor Peter Fonagy, Professor of Psychoanalysis and Chair, Guideline Development Group says “Depression in children is more common than many people realise and often goes unrecognised. Around 1% of children and 3% of adolescents will suffer from depression in any one year. It can severely impact on school performance, self esteem and making and retaining friendships. It can lead to a greatly increased risk of mental health problems in adult life and at its most serious it can dramatically increase the lifetime risk of suicide, from 1.3% in the general population to 6%.”

Ms Charlotte Dodds, Depression Support Group Co-Facilitator and Carer Representative on the Guideline Development Group says “Depression disproportionately affects the most disadvantaged children. Children and young people with emotional disorders, when compared with children without a mental disorder, were nearly twice as likely to be living with a lone parent (28% versus 15%), more than twice as likely to be with both parents being unemployed (27% versus 12%), and more likely to have parents who were on low incomes, had fewer qualifications and living in social sector housing. I hope this guideline raises awareness of the issue and encourages more equal access to treatments for all children and young people with depression, no matter where or how they live.”

Ms Dinah Morley, Deputy Director of YoungMinds says “YoungMinds welcomes the emphasis on psychological therapies as the best approach to the treatment of depression. However the very significant shortage of practitioners able to deliver these therapies is a cause for concern, as is the general lack of awareness of the prevalence of depression in babies, children and young people. We look to increasing investment in services which support the mental health of children and young people and to improvements in the training of all practitioners working with children, to help them in identifying symptoms of depression and in seeking effective help. Too many children’s lives are blighted by depression, a condition for which there are effective treatments. We welcome the NICE guidelines as another reminder that children’s mental health matters and is the business of everybody.”

The Committee on the Safety of Medicines issued advice on the safety of antidepressant medication for children in 2003. The NICE guidance complements and builds on this advice.

About NICE

1 On 1 April 2005 the National Institute for Clinical Excellence took on the functions of the Health Development Agency to form the National Institute for Health and Clinical Excellence (NICE). NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2 NICE produces guidance in three areas of health:
_ public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
_ health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
_ clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

About Yound Minds

1 YoungMinds is the national charity committed to improving the mental health of all children and young people.
The YoungMinds Parents’ Information Service (0800 018 2138) provides information and
advice for anyone with concerns about the mental health of a child or young person.

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Takeda Pharmaceutical Company
Limited (“Takeda,” Osaka, Japan) and BioNumerik Pharmaceuticals, Inc.
(“BioNumerik”, San Antonio, Texas) today announced the results of two Phase
III Trials for Tavocept(TM). Tavocept is an investigational new drug with
potential for oncology and non-oncology indications that was originated and
developed by BioNumerik.

The initial development focus for Tavocept has been as an
investigational new drug to prevent or mitigate the peripheral nerve
damage, or neuropathy, that is known to be associated with certain commonly
used classes of chemotherapy drugs, such as taxane and platinum agents.
Data was recently unblinded by BioNumerik from two placebo controlled
Tavocept Phase III clinical trials consisting of (1) a Phase III trial of
weekly administration of paclitaxel (a widely used taxane drug) to patients
with metastatic breast cancer enrolled from the United States, Russia, and
Ukraine (the “Weekly Paclitaxel Breast Cancer Trial”); and (2) a Phase III
trial involving administration of paclitaxel and cisplatin (a widely used
platinum drug) every 3 weeks to patients with non-small cell lung cancer
from Eastern and Western Europe (the “European Lung Cancer Trial”). Both of
these trials were aimed at evaluating Tavocept’s potential for a neuropathy
related treatment indication.

Each of the Phase III trials was designed as a randomized double-blind
placebo controlled trial with each patient to be randomly assigned to
receive either Tavocept or placebo in conjunction with chemotherapy. The
primary endpoints for the Weekly Paclitaxel Breast Cancer Trial and the
European Lung Cancer Trial were: (1) the total incidence of severe
neuropathy caused by the administration of chemotherapy in combination with
Tavocept or placebo; and (2) the difference in rates of tumor shrinkage in
patients receiving chemotherapy in combination with Tavocept or placebo, in
order to determine whether Tavocept has an impact on the anti-tumor effect
of chemotherapy.

Based on review and analysis of the results, the trials did not meet
their primary endpoints and they were inconclusive in terms of
demonstrating a statistically significant effect of Tavocept in reducing
the incidence of severe neuropathy caused by the administration of
paclitaxel and/or cisplatin. In addition, neither of the trials
demonstrated a statistically significant finding in terms of objective
tumor response rate or tumor protection as assessed in accordance with the
predefined statistical analysis plans for the trials, or by an independent
radiological review committee.

In commenting on the data, Frederick H. Hausheer, M.D., Chairman and
Chief Executive Officer of BioNumerik stated, “Many patients suffer from
chemotherapy induced neuropathy and there is no FDA-approved treatment to
prevent or reduce neuropathy caused by taxane and platinum chemotherapy
drugs. Although we did not see the results that we hoped to observe in
these Phase III trials, we believe there is evidence of potential clinical
activity of Tavocept that supports consideration of possible further
Tavocept development aimed at addressing the large unmet medical need for
neuroprotective agents. Certain trends and subgroup analyses for the trials
indicate that Tavocept may have potential for reducing chemotherapy-induced
neuropathy that merits consideration of further clinical testing. In
addition, the way that neuropathy was measured and the countries where the
trials were conducted may also have impacted the results.”

Subgroup analysis by country from the Weekly Paclitaxel Breast Cancer
Trial revealed a notable finding in favor of Tavocept in the reduction of
patient-reported severe neuropathy (as measured by Patient Neurotoxicity
Questionnaire (PNQ) grades D or E) for patients enrolled only from U.S.
sites. In this subpopulation comprising patients enrolled only from U.S.
sites, the incidence of patient-reported severe neuropathy confirmed for at
least 4 weeks (PNQ grades D or E) was 3.2% in the Tavocept group as
compared to 20.0% in the placebo group. This observation represents an 84%
lower incidence of severe neuropathy in favor of Tavocept. The Patient
Neurotoxicity Questionnaire (or PNQ) is a patient-based neuropathy
measurement tool that was used to measure neuropathy in the Tavocept Phase
III trials. The National Cancer Institute Common Toxicity Criteria
(“NCI-CTC”), a physician-based neuropathy measurement tool, showed a
consistent trend with that of the PNQ in terms of comparing the overall
severe neuropathy reported in the Tavocept and placebo arms for patients
from U.S. sites in the Weekly Paclitaxel Breast Cancer Trial. However, it
is also important to note that only about 8% of the total number of
patients treated in the Weekly Paclitaxel Breast Cancer Trial were treated
at U.S. clinical sites.

“An important factor supporting possible future Tavocept development
for a neuropathy indication is the subgroup analysis for patients enrolled
only at clinical sites located in the United States who participated in the
Weekly Paclitaxel Breast Cancer Trial,” said Hausheer. “We also observed
some encouraging trends in the Weekly Paclitaxel Breast Cancer Trial that
indicate potential activity of Tavocept in reducing moderate to severe
neuropathy. These are some of the first Phase III trials conducted to
assess the potential reduction of chemotherapy induced neuropathy. We
believe there may be modifications in the trial endpoints in the future as
well as changes in the procedures for assessing neuropathy in order to
clinically assess patients at risk for this complication and to address
some of the technical challenges we have observed in these trials to date.
While we are encouraged by some of the observations in these trials, it is
clear that additional clinical testing will be required to support
development of Tavocept for a neuropathy indication.”

Takeda has notified BioNumerik that, given the additional time
necessary to conduct additional clinical testing for a Tavocept neuropathy
indication, one possible alternative is termination of the existing
Tavocept License and Development Alliance Agreement between Takeda and
BioNumerik for the United States and Canada. Takeda and BioNumerik are
continuing to discuss the data from the trials as well as considerations
regarding the alliance agreement and the future development of Tavocept.

About Tavocept:

Tavocept is an investigational new drug with potential for oncology and
non-oncology indications that was originated and developed by BioNumerik.
Tavocept has potential applicability in multiple therapeutic areas
including diabetic neuropathy, protection against toxicity from radiation
therapy, lymphedema and other potential medical indications. In addition to
chemotherapy induced neuropathy, BioNumerik is evaluating further Tavocept
development possibilities in these areas.

About Takeda:

Takeda, located in Osaka, Japan, is a research-based global company
with its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda is
committed to striving toward better health for individuals and progress in
medicine by developing superior pharmaceutical products. Additional
information about Takeda is available through its corporate website,
takeda/index-e.html.

About BioNumerik:

BioNumerik, headquartered in San Antonio, Texas, is a pharmaceutical
company focused on the discovery, development and commercialization of
novel drugs for the treatment of patients with cancer. BioNumerik has two
drug candidates in late-stage clinical development: Tavocept(TM) and
Karenitecin (BNP1350).

BioNumerik Pharmaceuticals; Takeda Pharmaceutical Company
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