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Wednesday, October 3, 2018

Obesity in Toddlerhood Hard to Shake


Children’s body mass index (BMI) category in the first years of life was often carried through to adolescence, a German population-based study showed.
Most children stayed in the weight group they were in at age 5 through into ages 15 to 18, Antje Körner, MD, of the University of Leipzig, Germany, and colleagues reported in the New England Journal of Medicine.
Age 2 to 6 appeared to be a critical period: While 50% of those overweight (BMI standard-deviation score of 1.28 to <1.88) at 2 or younger achieved normal weight in adolescence, almost 90% of those who were obese (BMI SD score of 1.88 to <5) at age 3 were overweight or obese in adolescence.
The trajectory to obesity in the teen years followed a growth spurt from ages 2 to 6, with a 1.4-fold greater risk of overweight or obesity than seen among children with stable BMI in the preschool years.
High birthweight was a risk factor too, as 43.7% of those born large for gestational age were overweight or obese in adolescence. That corresponded to a 55% elevated risk of obesity in the teen years compared with other children.
The good news was that lower-weight preschoolers uncommonly became obese as teens.
Because teen obesity tends to carry over into adulthood, with metabolic and cardiovascular consequences, the findings have implications for identifying at-risk children based on early dynamics and patterns of BMI, Körner’s group noted.
“With regard to prevention, the clinical manifestation of obesity is a late starting point.” An annual increase of 0.2 or more in the BMI standard-deviation score during the preschool years “can be regarded as an early sign of ensuing obesity in adolescence that appears much earlier than the actual clinical manifestation of overweight.”
“A practical clinical implication of our study results would be surveillance for BMI acceleration, which should be recognized before 6 years of age, even in the absence of obesity.”
The researchers suggested tracking growth and weight patterns, particularly in those with maternal overweight or large-for-gestational-age status at birth, to prompt early intervention. “It is therefore important for healthcare professionals, educational staff, and parents to become more sensitive to this critical time period.”
The population-based study included 51,505 children with at least one measure of height and weight by age 14 and another at age 15 to 18, collected by pediatricians participating in the CrescNet patient registry at well-child or other office visits. The weight categories followed German national guidelines.
The findings were largely in line with prior studies, although those assessed a smaller age span or had limited sample size, the researchers noted. Studies that were well-powered missed the period from 2 to 7 years of age, “and hence began after the most pronounced weight gain had occurred.”
In an accompanying editorial, Michael Freemark, MD, of Duke University Medical Center in Durham, N.C., called the findings important, cautioning, however, that extrapolation to children in other countries is unclear, particularly in the developing world where the timing and magnitude of changes in BMI are often different from in Germany.
Another limitation was the inability to determine causality, he added, suggesting a clinical trial of early dietary intervention.
“We are now witness to an evolving epidemic of childhood obesity in the United States and other westernized countries … It is an ominous sign that the number of American children with the most severe and recalcitrant forms of obesity has increased progressively during the past 10 years. One hopes that interventions tailored to high-risk children at an early age can help to prevent or limit excess weight gain before obesity becomes irreversible.”
The study was supported by the German Research Council for the Clinical Research Center, German Federal Ministry of Education and Research, and Leipzig Research Center for Civilization Diseases (LIFE Child, supported by the European Union, the European Regional Development Fund, and the Free State of Saxony).
The CrescNet registry infrastructure was supported by grants from Hexal Germany, Novo Nordisk Pharma, Merck Serono Pharma, Lilly Deutschland, Pfizer Pharma, and Ipsen Pharma.
Körner reported financial relationships with the German Research Council, the European Regional Development Fund, the Federal Ministry of Education and Research, and Merck Serono, as well as non-financial support from Ferring Arzneimittel, Ipsen Pharma, and Eli Lilly.
Freemark reported grants from Rhythm Pharmaceuticals, the American Heart Association, and the Humanitarian Innovation Fund and European Commission, and personal fees from Springer Publishing.

Viking Presents on Phase 2 of Hip Fracture Study at Bone Confab


Viking Therapeutics, Inc. (‘Viking’) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive new findings from the company’s 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.
As previously reported, the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. Additionally, newly presented data demonstrated dose-dependent decreases in mean fat mass, coupled with dose-dependent increases in mean body weight following VK5211 treatment. Findings also demonstrated dose-dependent increases in 6-minute walk distance following VK5211 treatment, reaching a greater than 20-meter improvement over placebo at the study’s highest dose. The results were presented as part of the oral plenary session of the American Society for Bone and Mineral Research (ASBMR) 2018 annual meeting, held September 28 – October 1, 2018 in Montreal, Quebec, Canada.
VK5211, Viking’s lead program for musculoskeletal disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.

Nymox Reports Safety Benefits of Prostate Cancer, Hyperplasia Therapy


Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today that after long-term safety assessments of repeated Fexapotide Triflutate (FT) intraprostatic injections, there have been no identifiable risks or serious side effects or adverse events identified associated or linked with the drug.
FT is Nymox’s lead drug for which the Company is in the process of seeking U.S. and European marketing approvals for BPH (prostate enlargement), and FT is also in late stage development for prostate cancer. Pivotal trial results for FT BPH studies involving 977 treated patients were published in 2018 in the prestigious World Journal of Urology (May 2018, Volume 36, pages 801–809), and the safety and efficacy results have been presented to the American Urology Association and previously to the European Association of Urology.
Dr. Paul Averback, CEO of Nymox said, “For prostate cancer in particular, repeated injection treatments will be needed and a focal molecular treatment will have negligible value if there cannot be reliable safety expected from repeated injection.  Prostate cancer is a multi-focal disease and it is to be expected that multiple focal molecular treatments will be utilized for optimal outcomes. Follow-up and re-treatment will be needed. Nymox undertook 2 large FT re-injection safety studies in 2010-2014 involving 351 subjects with BPH, who were subsequently followed for up to 7 years. These mandatory and adequately sized safety studies are absolutely required in order to demonstrate safety of re-injection, and this is a standard requirement.”
Dr Averback added, “In addition, Nymox undertook extensive immunological testing involving over 1000 subject samples, demonstrating that FT does not lead to detectable antibody formation, which underlines FT safety and supports the lack of risk for allergic reactions. All laboratory testing and sexual function tests including semen analyses showed no changes in FT treated men compared to controls.”
Nymox’s lead drug Fexapotide (FT) has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo group study an 82-95% reduction in the number of these patients who required surgery after they received FT in the trial, as compared to patients who did not receive FT but instead later received conventional approved BPH treatments (p<.0001).
FT has been shown to produce long-term improvements in lower urinary tract symptoms associated with prostate enlargement (BPH), a problem that afflicts an estimated 100 million or more men in the world. FT does not cause the annoying side effects and risks found with available treatments for BPH. FT is also in development for low grade prostate cancer.
The clinical trial results for Fexapotide treatment of BPH are published in the World Journal of Urology May 2018, Volume 36, pages 801–809 (https://doi.org/10.1007/s00345-018-2185-y) in a peer review report entitled “Fexapotide Triflutate: Results of Long- Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement” authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY).

Leidos: Joins Cerner To Modernize Veterans’ Electronic Health Records


Leidos announced today it is joining Cerner, a global leader in health care technology, and other industry leaders and innovators to help make seamless care available to the nation’s veterans. This newly formed team announced by Cerner will bring extensive experience in large enterprise systems and commercial sectors to modernize the U.S. Department of Veterans Affairs (VA) electronic health record (EHR).

“As lead systems integrator for the DoD’s Defense Healthcare Management Systems Modernization (DHMSM) program, we are pleased that the deployment of MHS GENESIS will now include the VA,” said Jerry Hogge, senior vice president, Leidos. “We look forward to continuing our partnership with Cerner, further strengthening our joint mission to deliver an enhanced healthcare solution for both our active duty military, as well as our Veterans and their families.”
In addition to Cerner, Leidos will join Guidehouse, Accenture, Henry Schein One, AbleVets LLC, MicroHealth, ProSource360 and 17 additional small businesses – many of which are veteran-owned – to form the team that will provide experience and expertise to the VA implementation.
“We are proud Leidos will be part of this important team of industry leaders that will shape the future of care for veterans through a modern EHR system,” said Travis Dalton, president, Cerner Government Services. “We will work together to address the needs and capabilities that are in the best interest of the VA. Our veterans deserve the highest quality care and with this team, we look forward to bringing a modern, seamless system to those who have served our country.”
In May, Cerner announced an historic agreement and VA made the program one of their top priorities to improve care for veterans. Using technology that has been deployed successfully at Department of Defense (DoD) medical facilities and thousands of provider sites globally, Cerner plans to provide seamless care across the VA’s high-performing integrated network, including VA facilities, community providers and DoD facilities.
Leidos will join Cerner and other VA EHR modernization members to outline the strategy during the Cerner Health ConferenceOct. 8-11, in Kansas City, Mo.

Vtv Therapeutics up 122%


Thinly traded nano cap vTv Therapeutics (VTVT +121.6%) rockets on a whopping 121x surge in volume.
The company just filed an 8-K disclosing that top investor MacAndrews & Forbes Group, controlled by noted investor Ronald Perelman, just bought another 1,879,699 Class A common shares at $1.33 per share pursuant to a July 30 agreement. Its stake is now over 36M shares.

SeaSpine Announces Preliminary Results for Third Quarter


SeaSpine Holdings Corporation SPNE, +6.86% a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended September 30, 2018.
Preliminary and unaudited revenue for third quarter 2018 is expected to be in the range of $35.5 to $36.0 million, reflecting approximately 12% to 13% growth compared to the prior year period. Compared to third quarter 2017, total U.S. revenue is expected to increase between 12% to 13% to approximately $31.5 to $31.8 million, with both U.S. Orthobiologics and U.S. Spinal Implants revenue expected to increase more than 10%. International revenue is expected to increase between 14% and 20% to approximately $4.0 to $4.2 million.
Cash and cash equivalents at September 30, 2018 are expected to be approximately $11.5 million. The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under the credit facility as of September 30, 2018. The Company has not sold any shares of its common stock under its $50 million “at the market” equity offering program.
“We are pleased by our revenue results for the third quarter, which reflect solid revenue growth across all portfolios,” said Keith Valentine, President and Chief Executive Officer. “This momentum is driven by increasing market penetration from our recently launched products, a more engaged and increasingly exclusive distributor network, and from a deeper commitment in our organization to customer experience and medical education and training. We are confident that we are well positioned to sustain this growth as we continue to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”
2018 Financial Outlook
SeaSpine is increasing its full-year 2018 revenue guidance range to $141 to $142 million, up from $136 to $139 million, reflecting growth of approximately 7% to 8% over full-year 2017 revenue.
Upcoming Investor Conferences
As previously announced, SeaSpine management is scheduled to present at the Ladenburg Thalmann 2018 Healthcare Conference in New York, NY today, October 2 at 3:00pm ET. SeaSpine management is also scheduled to present at the Cantor Global Healthcare Conference in New York, NY on Wednesday, October 3 at 9:10am ET. A live webcast of both presentations will be available on the Investor Relations page of the Company’s website at www.seaspine.com. A replay of each presentation will be available on the website for 30 days following the event.

Compressions May Remedy Venous Leg Ulcers


Heel compressions to stimulate circulation in the legs, along with regular walking or some other form of exercise, are helpful in healing venous leg ulcers (VLUs), a systemic review and meta-analysis found.
The findings were based on a comparison between exercise groups and control groups. Exercise was linked with increased healing rates of 14 additional cases per 100 patients, while progressive exercise in conjunction with prescribed physical activity was linked with increased healing of 27 additional cases per 100 patients, reported Andrew Jull, RN, PhD, of University of Auckland, and colleagues in JAMA Dermatology.
The evidence base is limited because of the number of randomized participants and the need for more conclusive trials. However, there is enough evidence for clinicians to recommend the appropriate patients implement progressive resistance exercises and 30 minutes of walking at least 3 days per week into their care, noted the study authors.
“Even if this evidence is found to be incorrect in the future, it is unlikely that such an approach will disadvantage patients, given the benefits of physical activity and the impact of prolonged inactivity on function,” the investigators continued.
Robert Kirsner, MD, PhD, of University of Miami Miller School of Medicine in Florida, noted in an accompanying editorial that venous leg ulcers are “among the most prevalent and costly skin diseases,” affecting some 2% of older individuals each year.
Even with quality care a substantial number “of leg ulcers do not fully heal after 6 months, leading to significant impact in quality of life from pain, mobility issues, and embarrassment from foul-smelling and draining wounds. Other targets for intervention, therefore, are critically needed,” Kirsner wrote.
He was generally supportive of the meta-analysis, while noting its inherent limitations. With the current findings, he wrote, “we are now empowered to recommend exercise for patients with VLUs, while we await further studies that better elucidate how to best target this intervention, informing us which patients with VLUs will benefit most and why.”
Weak Literature
But other dermatologists contacted by MedPage Today were more cautious.
“I don’t doubt that patients who did exercise healed better, but the data is not large enough to say how much effect the exercise does, and the exercise used in each study was not universal,” said Sahoko Little, MD, PhD, of University of Michigan in Ann Arbor.
“Many of the patients who have venous stasis ulcers are very sedentary, and/or have physical limitations. The patients who can do prescribed exercises are not [the] majority of the patients with venous stasis ulcers,” continued Little.
William Huang, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, noted politely that Jull and colleagues “did their best to try and systematically review available literature.”
But that literature remains weak, he suggested. “Most of the studies are small, few in number, lack sufficient blinding, and outcomes vary, creating problems with coming up with definitive conclusions,” Huang told MedPage Today. “The evidence to support exercise as a component of venous leg ulceration treatment is still limited. Our ‘best evidence’ does suggest that this is a low-risk, low-cost, and simple intervention that may help some patients but we don’t have strong enough evidence to universally recommend [it] for all.”
Study Details
The researchers analyzed 190 participants using data from five randomized controlled trials (RCTs), in which exercise was compared with no exercise in venous leg ulcer patients, compression was a form of standard therapy, and healing outcomes were measured.
The investigators report using the following exercise interventions were included: exercise alone (two RCTs, 53 participants), progressive resistance exercise and prescribed physical activity (two RCTs, 102 participants), walking (one RCT, 35 participants), and ankle exercise (one RCT, 40 participants).
Two trials had participants with adverse events. In one of the trials, the researchers reported, if only the first event of a type was considered, 38 events were reported by intervention participants and 26 by usual care participants (OR 1.32; 95% CI 0.95-1.85), while the second trial reported two non-serious adverse events related to exercise and no adverse events among the group of patients receiving standard care.
One trial reported medical care costs. For exercise participants, the cost per patient to health services was €1,423 and €2,299 for the usual care group, translating to €875 in cost savings per patient each year. Moreover, the researchers also calculated the cost to the patient, which was €114 for the exercise group and €175 for the usual care group, resulting in a cost saving per patient of €61 each year. (Currently, €1 = $1.15.)
Jull, Kirsner, and Huang did not report any disclosures.
  • Reviewed by Dori F. Zaleznik, MD Associate Clinical Professor of Medicine (Retired), Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner
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