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Monthly Archives: March 2017
Mesoblast’s (MESO) Regenerative Cell Therapy Proves Itself in Back Pain Trial – Economic Calendar
Posted: March 16, 2017 at 4:41 am
This morning, Australian biotech company Mesoblast Ltd (NASDAQ:MESO) announced encouraging phase 2 trial data regarding its regenerative therapy for chronic lower back pain (CLBP). Mesoblasts proprietary allogeneic Mesenchymal Precursor Cells (MPCs) are given to patients via a single injection and, in the clinical trial, have proved to spark significant improvement in both lower back pain and function that lasted for at least 36 months.
The sustained benefits on pain and function over three years seen with a single injection of Mesoblasts cell therapy have the potential to transform the treatment paradigm for chronic low back pain due to disc degeneration, said Dr. Hyun Bae, the trial investigator and Director of the Spine Institute.
According to Bae, there is growing evidence that disc degeneration can be healed instead of needing to be replaced or fused. Researchers are quickly arriving at this inflection point in the treatment of lower back pain, which is especially critical given the ongoing opioid abuse epidemic sweeping the nation.
Researchers believe that MPCs are turned on by signals in damaged tissues that spark factors to block damaging inflammation and begin repairing the afflicted area.
The phase 2 trial in question involved 100 patients, who were treated with either six million or 18 million MPCs via one intra-discal injection or a placebo of either saline or hyaluronic aid. The primary endpoints were a 50 percent drop in Visual Analog Scale (CAS), which is a pain metric, and a 15-point reduction in Oswestry disability index (ODI) at both the one and two year marks.
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The primary endpoint composite at the two-year mark was met by 41 percent of patients in the 6 million MPC arm, 35 percent in the 18 million arm, with just 18 percent and 13 percent in the placebo groups. The phase 2 results support the companys criteria for its ongoing phase 3 program.
Mesoblast is confident that the durable treatment outcomes in lower back pain are part of an overarching mechanism that might also have a positive effect in other types of chronic conditions where a single injection of MPCs can lead to sustained benefits. Two of these potential indications, according to Mesoblast, are chronic heart failure and biological-resistant rheumatoid arthritis.
Following the trial data being released, Maxim Groups Jason Kolbert reaffirmed a Buy rating on Mesoblasts stock and maintained a price target at $14.00. The upside indicated is 81 percent.
The market opportunity is significant and the treatment fits ideally within the existing paradigm the analyst told investors this morning. Injecting cells versus steroids with a better AE profile and now a better long-term result.
Earlier this month, Mesoblast announced that its MSC-100-IV therapy had been given Fast Track designation by the Food and Drug Administration (FDA) for its use in children with steroid refractory acute Graft Versus Host Disease (aGVHD). This type of designation shortens the FDA review path from ten months to six months, and certain portions of the Biologics License Application (BLA) can be sent in on a rolling basis rather than when everything is finished.
The author of this article holds no position in any of the stocks mentioned above.
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Free diabetes self-management workshops offered in Pleasantville – Shore News Today
Posted: March 16, 2017 at 4:40 am
PLEASANTVILLE Quality Insights Quality Innovation Network, supported locally by Healthcare Quality Strategies Inc., is partnering with Pleasantville to provide free diabetes workshops as part of the Everyone with Diabetes Counts program.
The EDC program is a national initiative of the Centers for Medicare and Medicaid Services.
The program offers free self-management workshops for people with Medicare who have diabetes, their family members and caregivers.
The free workshops follow the Stanford University Diabetes Self-Management Program.
The workshops are designed to help individuals learn how to manage their diabetes and take control of their health through behavior modification and coping techniques. Participants will learn about diabetes and its risks, preventing complications, the importance of healthy eating, the role of exercise, how to deal with stress and difficult emotions, managing medications, effective communication with healthcare providers, and much more.
This free six-week workshop will be offered at the Pleasantville Branch Library, 33 Martin Luther King Jr. Ave.
Workshops are 10 a.m. to 12:30 p.m. Tuesdays from April 11 to May 16.
Everyone must register by the second workshop session.
Each participant, one per household, will receive a free book, Living a Healthy Life with Chronic Conditions at the second workshop session.
For information or to register, call Jarmaine Williams at 732-955-8168. Visit http://www.qualityinsights-qin.org to learn more about Quality Insights Quality Innovation Network, or to read real success stories about people with diabetes in New Jersey who have completed this program and made motivational improvements to their health and lives.
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Intensive Type 2 Diabetes Treatment Promising – WebMD
Posted: March 16, 2017 at 4:40 am
By Karen Pallarito
HealthDay Reporter
WEDNESDAY, March 15, 2017 (HealthDay News) -- Instead of managing type 2 diabetes as a chronic condition, what if people could beat the disease?
That was the thinking behind a small pilot study, which suggested that intensive treatment with oral medicine, insulin, diet and exercise might knock out the disease, at least for several months, in certain patients.
Up to 40 percent of patients who were treated experienced complete or partial remission for three months, the study found.
"We are now able to possibly reverse diabetes, and that really motivates patients to do their best in terms of losing weight and making sure their sugars are normalized," said lead author Dr. Natalia McInnes.
She's an assistant professor of endocrinology and metabolism at McMaster University in Ontario, Canada.
However, relatively few participants remained in remission a year later, diabetes experts noted.
"Rates of diabetes remission did not appear to differ significantly at 52 weeks between 'control' and 'intervention' groups, so the effects do not appear to be sustained," said Dr. Christine Lee of the U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
And, Dr. Philip Kern, professor of endocrinology at the University of Kentucky in Lexington, added, "If you don't sustain the lifestyle intervention, then the disease is going to come back."
The bodies of people with type 2 diabetes don't use insulin properly. Insulin is a hormone that helps move sugar into cells to be used as fuel. At first, the body responds by making more insulin, but eventually, your body cannot make enough insulin to keep up with the demand. This leads to increasing blood sugar levels. Over time, uncontrolled blood sugar levels can damage the nerves, eyes, kidneys or heart, according to the American Diabetes Association.
Adults newly diagnosed with type 2 diabetes were invited to participate in the trial. Each was randomly assigned to receive either two months or four months of treatment, or "usual diabetes care" (the control group).
The trial included 83 people, aged 30 to 80 years. The participants had had type 2 diabetes for up to three years, and managed their diabetes with diet alone or with one or two drugs. People already taking insulin were excluded from the study.
Senior investigator Dr. Hertzel Gerstein of McMaster University devised the drug combo used in the trial, McInnes said.
Patients received two oral diabetes medicines -- metformin (Glucophage, Glumetza, Fortamet) and acarbose (Precose) -- plus a long-acting type of injectable insulin called insulin glargine (Lantus), based on evidence that these drugs can slow or prevent diabetes, Gerstein explained in a news release from the Endocrine Society.
Once the experiment began, the two intervention groups stopped other diabetes medicines and started the new regimen, according to the report.
A dietician provided a suggested meal plan, encouraging patients to cut 500 to 750 calories a day.
A kinesiologist (body movement expert) prescribed individual fitness programs with a goal of 150 minutes of moderate-intensity exercise per week, by week 16 of the trial. Patients were also given pedometers and instructed to work toward 10,000 steps per day.
Control group members received standard blood-sugar management advice, the study authors noted.
Hemoglobin A1c tests, which measure average blood sugar levels over the past two to three months, were administered at four points during the study. An A1c level below 5.7 percent is considered normal, according to the American Diabetes Association.
In the study, complete remission was defined as an A1c under 6.0 percent and no need for diabetes medication. Partial remission was an A1c of less than 6.5 percent and no need for diabetes medication.
Three months after the intervention, 11 out of 27 people in the 16-week study group experienced complete or partial diabetes remission, versus six out of 28 in the eight-week study group, and four out of 28 in the control group, the researchers found.
It isn't clear whether the diabetes remission was due to medical therapy with drugs or weight loss with intensive lifestyle therapy, said NIDDK's Lee, who is program director in the diabetes, endocrinology and metabolic diseases division.
The study authors didn't evaluate the cost of the intervention versus potential cost savings. McInnes suspects it would save money in the long term if it reversed the disease and prevented expenses related to ongoing diabetes care and complications.
She said additional studies are needed to assess whether it's possible to achieve higher, and prolonged, rates of remission with similar combinations of therapies.
Kern said the study serves as a reminder that lifestyle interventions in diabetes "really do work."
The study was published online March 15 in the Journal of Clinical Endocrinology & Metabolism.
WebMD News from HealthDay
SOURCES: Natalia McInnes, M.D., assistant professor, endocrinology and metabolism, department of medicine, McMaster University, Ontario, Canada; Christine Lee, M.D., program director, division of diabetes, endocrinology and metabolic diseases, U.S. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.; Philip Kern, professor of endocrinology, University of Kentucky, Lexington; March 15, 2017, Journal of Clinical Endocrinology & Metabolism, online
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Scientists Reverse Type 2 Diabetes with Intensive Medical Treatment – Voice of America
Posted: March 16, 2017 at 4:40 am
Scientists have reversed Type 2 diabetes in a study of patients who underwent intensive medical treatment to control their blood sugar levels.
By following a regimen of strict diet, exercise and medications, up to 40 percent of the participants managed to stay in remission for three months after stopping their medication.
The research was conducted by investigators at McMaster University in Ontario, Canada.
Researchers divided 83 individuals with Type 2 diabetes into three groups. Two of the groups received intensive metabolic intervention that included a personalized meal plan that cut their daily caloric intake by 500 to 750 calories per day. They were also given an individualized exercise plan, met with a dietitian regularly and took medication and insulin at bedtime to help control blood glucose.
The only difference is one group was intensively treated for 16 weeks while the other group received the same intervention for just eight weeks.
They were compared to a third group of participants that was given standard diabetic management information from a health care provider, including lifestyle advice.
All of the participants had their blood glucose measured at 20, 28 and 52 weeks to see how well their blood sugar was controlled.
After eight and 16 weeks of the intensive intervention, medication was stopped in both groups.
In the 16-week group, 11 of 27 participants met the criteria for complete or partial remission of their diabetes for a period of three months after the trial.
In the eight-week intensive therapy group, six out of 28 individuals were in remission for three months after the intervention was completed. Only four out of 28 patients in the control group showed remission.
The results of the study were published in the Journal of Clinical Endocrinology and Metabolism.
Could change diabetes treatment
Lead researcher Natalia McInness thinks the finding may shift the way adults with diabetes are treated from simply managing their blood sugar levels to a program of intensive therapy to put the disease into remission. Under that strategy, patients would be watched for signs of relapse and treated accordingly.
In Type 2 diabetes, the body either doesnt make enough of the hormone insulin, in severe cases, to ferry nutrients into cells or the cells become resistant to insulin.
Either way, McInness believes the intensive therapy intervention gives the pancreas a rest, decreasing fat stores in the body that in turn improve insulin production and sensitivity. The pancreas is the organ that produces insulin.
She said the findings support the notion that Type 2 diabetes can be reversed, at least in the short term, through strict medical management. The idea of putting diabetic patients into remission, said McInness, could be very appealing, motivating them to make significant lifestyle changes.
Diabetes is a growing epidemic worldwide and patients struggle to maintain blood sugar levels in the normal range to avoid severe complications like heart disease, blindness and kidney failure.
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Whole-body Vibration May Improve Diabetes Control, Study Finds – Voice of America
Posted: March 16, 2017 at 4:40 am
Researchers have found that a less strenuous form of exercise known as whole-body vibration may work just as well as regular exercise in helping to control diabetes. WBV, as it's called, could also benefit people who find it difficult to exercise.
Scientists say WBV transmits energy through the body when someone is standing, sitting or lying on a gently vibrating device, causing muscles to contract and relax many times each second.
The effect may be to strengthen and increase muscle mass, improving blood sugar control along with other problems seen in diabetes. At least, that's what studies in mice suggest.
Bearing in mind that exercise is good for everyone, including people with diabetes, researchers at Augusta University in Augusta, Georgia, studied five-week-old male rodents, comparing the effects of whole-body vibration to that of running on a treadmill.
Vibrating platform
A cage containing both normal and specially bred obese, diabetic mice was placed on a gently vibrating platform for 20 minutes per day for 12 weeks.
Another group of rodents both diabetic and healthy mice was trained to run on a treadmill for 45 minutes a day for the same period of time.
A third group of diabetic and healthy mice remained sedentary and were used for comparison.
Investigators saw similar health benefits in the diabetic mice that ran on the treadmill and those exposed to whole-body vibration.
Meghan McGee-Lawrence, an assistant professor in the Department of Cellular Biology and Anatomy at the Medical College of Georgia, said the results of the study showed that "vibration may be just as effective as exercise at combating some of the negative consequences of obesity and diabetes."
Biomarker improvements
McGee-Lawrence said mice subjected to whole-body vibration and those that ran on the treadmill were both able to decrease fat in the liver, improve insulin sensitivity and increase muscle fiber.
While there was improvement in the biomarkers of diabetic WBV mice and treadmill mice, they never became as healthy as the normal animals.
During the study, the mice were weighed weekly. Researchers found that the diabetic mice subjected to vibration and the treadmill gained less weight after the study was over than the sedentary rodents.
There was also evidence that whole-body vibration might improve the bone strength of diabetics.
The study was published in the journal Endocrinology.
McGee-Lawrence said researchers are now trying to determine the mechanisms that underlie improved diabetes control in both exercise and whole-body vibration mice.
More study urged
There are vibrating chairs and beds available on the market, but McGee-Lawrence cautioned people against starting a routine of whole-body vibration and thinking they are controlling their diabetes.
"We know that some whole-body vibration ... seems to be good for the body, but too much can be a bad thing," she said. "And in terms of finding ways to apply that [to humans] ... I think we need some more studies to guide us on that so that when folks start doing this, we get the best beneficial effects we can without running the risk of having any potential side effects."
One potential harm of too much vibration, often seen heavy-machine operators, is tissue inflammation.
If researchers are able to repeat the results in humans, McGee-Lawrence said, whole-body vibration could be a useful add-on to the treatment of diabetes.
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Free educational diabetes program offered in March, April – YourGV.com
Posted: March 16, 2017 at 4:40 am
The public is invited to attend a free educational program on preventing and reversing diabetes to be held from 5 to 7:30 p.m. on March 19, 26 through April 2, 9, 16, 23 at the Fairfield Inn & Suites located at 1120 Bill Tuck Highway in South Boston.
Persons may pre-register by leaving their name and number by calling 1-877-695-3377. Someone will make contact to confirm registration.
The free six weeks Diabetes Preventing and Reversial Seminar is sponsored by Emmanuel Seventh-Day Adventist Church.
Type 2 Diabetes is increasing at an alarming rate. And yet there is nothing catching about it. People cannot get it from anyone else.
Rather, the health care community now knows that Type 2 Diabetes is caused by the things people do, their lifestyle.
Identifying and connecting with people at high risk of Type 2 Diabetes is critical to preventing it.
One check of the Centers for Disease Control and Preventions website for the latest updates indicates for the first time, a big shift has taken place from just reporting on efforts of treating the disease to efforts related to preventing it.
Below is some of the information to be gleaned from their website.
Diabetes was the seventh leading cause of death in the United States in 2013, but this may be underreported, according to the CDC. While it is more easily identified as the cause of blindness, lower-limb amputations and kidney failure, doctors are not able to easily identify diabetes as the cause of heart attacks or strokes. So, while its reported that a person died from a stroke, the real cause of death may have been the diabetes that caused the stroke.
The rate of new cases of diagnosed diabetes is still very high. More than 29 million U.S. adults have diabetes, and 25 percent of those do not know that they have it.
Furthermore, more than a third of American adults around 86 million have prediabetes, and 90 percent of them dont know it. Looking at the County Health Rankings (www.countyhealthrankings.org) provided by the Robert Wood Johnson Foundation, Halifax County has a diabetes rate of 15 percent. The average for the State of Virginia is 9 percent and is one of the top performers in the U.S.
In 2016, the CDC partnered with the American Diabetes Association, American Medical Association and the Ad Council to start running public service announcements (PSAs). This is the first national prediabetes awareness campaign.
These PSAs are reaching millions of people who may be at risk and are encouraging them to take a risk assessment to find out their status. These risks include being overweight, being 45 years or older, having a family history of Type 2 diabetes and being physically active less than three times a week. People who have one or more of these risk factors should talk to their doctor about getting their blood sugar tested or testing their Hemaglobin A1c.
The Mayo Clinic reports that if a person has prediabetes, the long-term damage of diabetes, especially to ones heart and circulation may already be starting.
Persons with prediabetes have an increased risk of Type 2 Diabetes, heart disease and stroke. For people living with diabetes, better health management can increase lifespan and improve the quality of life. Or through lifestyle education and coaching, a person may be able to reverse diabetes and again live diabetes-free.
Coming to South Boston in March is the Grundy Preventing and Reversing Diabetes Seminar, the program reveals that many changes have been made to peoples lifestyle in the past that have contributed to diabetes.
If one knows what those changes are, it will empower them to make better choices that will lead to better health and disease reversal.
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Sanofi, Voluntis Ink Diabetes Tech Pact (SNY, NVO) – Investopedia
Posted: March 16, 2017 at 4:40 am
Investopedia | Sanofi, Voluntis Ink Diabetes Tech Pact (SNY, NVO) Investopedia The deal builds on an existing relationship between the two companies, and banks on combining Sanofi's established expertise in diabetes treatment and Voluntis' experience in building companion software. Sanofi and Voluntis have a longstanding ... Sanofi and Voluntis to deliver global mobile app for type 2 diabetes |
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The Numeric Investors LLC Purchases New Position in Puma Biotechnology Inc (PBYI) – Petro Global News 24
Posted: March 15, 2017 at 5:48 am
Numeric Investors LLC acquired a new stake in Puma Biotechnology Inc (NYSE:PBYI) during the fourth quarter, Holdings Channel reports. The fund acquired 37,200 shares of the biopharmaceutical companys stock, valued at approximately $1,142,000.
A number of other hedge funds and other institutional investors also recently bought and sold shares of PBYI. Tower Research Capital LLC TRC boosted its stake in shares of Puma Biotechnology by 253.3% in the third quarter. Tower Research Capital LLC TRC now owns 2,427 shares of the biopharmaceutical companys stock valued at $163,000 after buying an additional 1,740 shares during the last quarter. Legal & General Group Plc boosted its stake in shares of Puma Biotechnology by 142.4% in the second quarter. Legal & General Group Plc now owns 6,142 shares of the biopharmaceutical companys stock valued at $183,000 after buying an additional 3,608 shares during the last quarter. Ardsley Advisory Partners acquired a new stake in shares of Puma Biotechnology during the third quarter valued at approximately $201,000. Laurion Capital Management LP acquired a new stake in shares of Puma Biotechnology during the third quarter valued at approximately $208,000. Finally, Perceptive Advisors LLC acquired a new stake in shares of Puma Biotechnology during the fourth quarter valued at approximately $225,000. Hedge funds and other institutional investors own 80.98% of the companys stock.
Shares of Puma Biotechnology Inc (NYSE:PBYI) traded up 3.37% during trading on Monday, hitting $41.40. 210,498 shares of the stock traded hands. The firms market capitalization is $1.53 billion. Puma Biotechnology Inc has a 1-year low of $19.74 and a 1-year high of $73.27. The firm has a 50-day moving average of $35.26 and a 200-day moving average of $44.21.
Puma Biotechnology (NYSE:PBYI) last issued its earnings results on Wednesday, March 1st. The biopharmaceutical company reported ($2.04) earnings per share for the quarter, missing analysts consensus estimates of ($1.92) by $0.12. On average, equities analysts forecast that Puma Biotechnology Inc will post ($8.32) earnings per share for the current year.
PBYI has been the subject of several recent research reports. Citigroup Inc set a $88.00 target price on shares of Puma Biotechnology and gave the company a buy rating in a research report on Tuesday, January 3rd. JPMorgan Chase & Co. set a $89.00 target price on shares of Puma Biotechnology and gave the company a buy rating in a research report on Monday, November 14th. Royal Bank of Canada reiterated a sector perform rating and set a $17.00 target price (down previously from $48.00) on shares of Puma Biotechnology in a research report on Thursday, March 2nd. Credit Suisse Group AG reiterated an outperform rating and set a $111.00 target price on shares of Puma Biotechnology in a research report on Tuesday, November 15th. Finally, Stifel Nicolaus reiterated a buy rating and set a $88.00 target price on shares of Puma Biotechnology in a research report on Wednesday, November 30th. One equities research analyst has rated the stock with a sell rating, three have issued a hold rating and four have given a buy rating to the company. The company presently has an average rating of Hold and a consensus price target of $73.50.
In other Puma Biotechnology news, insider Alan H. Auerbach sold 10,202 shares of the firms stock in a transaction that occurred on Friday, January 20th. The shares were sold at an average price of $33.24, for a total value of $339,114.48. Following the sale, the insider now owns 4,179,798 shares in the company, valued at $138,936,485.52. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through this link. Also, SVP Richard Paul Bryce sold 2,293 shares of the firms stock in a transaction that occurred on Friday, January 20th. The shares were sold at an average price of $33.24, for a total transaction of $76,219.32. Following the completion of the sale, the senior vice president now owns 29,237 shares in the company, valued at approximately $971,837.88. The disclosure for this sale can be found here. Insiders sold 15,503 shares of company stock worth $511,078 in the last 90 days. Company insiders own 22.70% of the companys stock.
Puma Biotechnology Company Profile
Puma Biotechnology, Inc is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer. The Company focuses on in-licensing the global development and commercialization rights to over three drug candidates, including PB272 (neratinib (oral)), which the Company is developing for the treatment of patients with human epidermal growth factor receptor type 2 (HER2), positive breast cancer, and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of patients with advanced cancer, and PB357, which is an orally administered agent.
Want to see what other hedge funds are holding PBYI? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Puma Biotechnology Inc (NYSE:PBYI).
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Indianapolis workers part of Roche Diabetes Care layoffs | Fox 59 – Fox 59
Posted: March 15, 2017 at 5:46 am
INDIANAPOLIS, Ind. Roche Diabetes Care, Inc. announced Tuesday that it will lay off 157 employees as it restructures its U.S. Commercial Operations, 42 of which are Indianapolis-based.
The company says 133 of those employees are full-time and 24 are contractors.
Roche said in a statement that it made the decision to address the competitive diabetes care market and secure the long-term viability of its business.
Roche is deeply grateful to all those who have contributed and dedicated themselves to the company and the millions of people living with diabetes, the statement read. The company is committed to supporting its colleagues in identifying other positions within the wider Roche organization where possible.
Roche says its the worlds largest biotech company, with differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Its also reportedly the leader in in vitro diagnostics and tissue-based cancer diagnostics. Its headquarters is in Basel, Switzerland.
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3-D visualization of the pancreas: New tool in diabetes research – Science Daily
Posted: March 15, 2017 at 5:46 am
Science Daily | 3-D visualization of the pancreas: New tool in diabetes research Science Daily The wealth of visual and quantitative information may serve as powerful reference resource for diabetes researchers. The Ume University researchers are now publishing their datasets in Scientific Data, which is a Nature Research journal for ... |
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