Biondvax’s Universal Flu Vaccine Receives Additional US Patent

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) developer of a Universal Flu Vaccine currently undergoing late-stage 2 clinical trials, announced today that its patent application in the United States titled “Multimeric Multi-Epitope Polypeptides in Improved Seasonal and Pandemic Influenza Vaccines” has completed examination and is allowed for issuance as a patent.

The invention covers the use of BiondVax’s universal flu vaccine as a prime-boost to the current commercially available flu vaccine. Results from BiondVax’s completed clinical trials have shown significantly increased effectiveness against multiple flu strains.

Ron Babecoff, CEO of BiondVax commented, “Current flu vaccines are strain specific and are not particularly effective against circulating ‘wild-type’ strains due to mismatches. In fact, last year’s seasonal flu vaccine was only 23% effective^[1]. Conversely, our vaccine provides long-lasting and higher effectiveness against multiple flu strains.”

Continued Dr. Babecoff, “Our newly approved US patent demonstrates the novel nature of our vaccine technology and strengthens our IP portfolio for many years to come.”

Contego Medical Presents Data For Paladin® Carotid Post-Dilation Balloon

Contego Medical, an innovator in developing next generation treatments for coronary and peripheral artery disease, today presented positive post-market registry data for the Paladin® Carotid Post-Dilation Balloon with Integrated Embolic Protection™ (IEP) Technology at LINC 2016, in Leipzig, Germany. The presentation included compelling results from a diffusion-weighted MRI (DW-MRI) sub-study that showed improved patient outcomes with the Paladin System.

Dr. Ravish Sachar, CEO and Founder of Contego Medical, presented the preliminary results on symptomatic and asymptomatic carotid stenosis patients for 50 post-market registry patients and 15 DW-MRI sub-study patients. The post-market registry demonstrated a 100 percent success rate for delivery and deployment of the Paladin System, without the occurrence of device related complications over a 30-day follow-up period.  Exhibiting excellent outcomes, the DW-MRI sub-study results compare favorably to published results for carotid stenting with single distal protection or proximal protection.

“These preliminary results are consistent with previous findings and validate the Paladin System as a new meaningful technology in the carotid market,” stated Dr. Ralf Langhoff, Director of Angiology, Saint Getrauden Hospital, Berlin, Germany. “My experience in the post-market registry has been very positive. By incorporating this system into my practice, I can post-dilate the carotid stent and capture smaller embolic debris in a single step.”

The Paladin System provides vital embolic protection during the critical post-dilation step of a carotid stent procedure. By integrating a low-profile balloon and a 40-micron embolic filter into one catheter, the system simplifies the procedure and may improve safety.

“The positive results strengthen our belief in the Paladin System and the promise it holds to reduce the incidence of stroke in patients undergoing a carotid stenting procedure,” commented Dr. Sachar. “Emboldened by the enthusiasm that continues to grow in the European clinical community, we are committed to ongoing clinical research to rigorously study this novel platform.”

FDA Warns Consumers Not to Use Licorice Coughing Liquid

The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine.

The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine,  consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product. Other effects of morphine can include, but are not limited to, respiratory depression and death.

Consumers should not purchase this cough syrup and anyone who has this product should not use it.

This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product.

This product is available on-line and in some retail stores.

Consumers are advised to report any side effects or reactions from the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular Mail or FAX: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addresses form, or submit by fax to 1-800-FDA-0178.

FDA approvals for Cosentyx for ankylosing spondylitis and psoriatic arthritis

Novartis announced today that the US Food and Drug Administration (FDA) has approved Cosentyx^®(secukinumab) for two new indications – the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.^2,3,4

With these new approvals, Cosentyx is now the first and only interleukin-17A (IL-17A) antagonist approved for AS, as well as moderate to severe plaque psoriasis and PsA, which impacts as many as 30% of patients with psoriasis.⁵ Cosentyx was approved for adult patients with moderate to severe plaque psoriasis in January 2015 and more than 13,000 patients with this disease in the US have already been treated with Cosentyx.

“We were inspired by patients to pursue new indications for AS and PsA, because these diseases can result in significant pain and impede the simplest of tasks in a person’s daily life,” said Christi Shaw, US Country Head, President at Novartis Corporation and Novartis Pharmaceuticals Corporation. “The approval of additional indications for Cosentyx represents an important milestone for AS and PsA patients, their caregivers, and their doctors.”

The approvals are based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively.¹ ASAS20 and ACR20 are standard tools used to assess clinical improvement in AS and PsA. The safety profile is consistent across the three approved indications.¹

“Working directly with patients who have AS and PsA, I have seen firsthand the devastating impact the diseases can have,” said Philip Mease, MD, director of rheumatology research at Swedish Medical Center, clinical professor at the University of Washington School of Medicine in Seattle and an investigator in the Cosentyx clinical trial program. “I welcome the addition of Cosentyx as a new treatment option for my patients with AS and PsA.”

About ankylosing spondylitis (AS)

• Ankylosing spondylitis (AS) is a painful and often progressively debilitating disease, caused by spine inflammation that can result in irreversible damage.⁶
• Up to 70% of patients who go on to develop severe AS will form spinal fusions (where the bones grow together) over 10 to 15 years, which significantly reduces mobility.⁷
• In the United States, the prevalence of AS is estimated to be between 0.2% and 0.5%, with nearly half a million people affected.^8,9
• Males are affected most often and family members of those with AS are at higher risk.¹⁰
• Approximately 20-40% of patients do not respond well to standard of care biologic medicines, and there are few therapeutic options available to those patients.¹¹

About psoriatic arthritis (PsA)

• Between 0.3% and 1% of the general population may be affected by psoriatic arthritis (PsA) and up to 15% of people with psoriasis may have undiagnosed PsA.^12,13
• Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers and persistent painful ethesitis (inflammation of the sites where tendons or ligaments insert into the bone).³
• PsA can lead to irreversible joint damage and disability caused by years of inflammation.³
• Up to 40% of people can suffer from joint destruction and permanent physical deformity.¹⁴
• New medicines are needed as many patients do not respond to, or tolerate current therapies and approximately 45% of PsA patients are dissatisfied with treatments.¹⁵

About Cosentyx AS and PsA clinical trial programsPivotal Phase III studies in the Cosentyx clinical trial program that provided key data for the submission were MEASURE 1 and MEASURE 2 involving 590 patients with AS, and FUTURE 1 and FUTURE 2 including 1,003 patients with PsA. Data from these pivotal trials were published in The New England Journal of Medicine and The Lancet. These are multi-center, randomized, placebo-controlled studies designed to evaluate the efficacy and safety of Cosentyx in AS and PsA.^16,17,18 Additional follow-up of patients from these trials is still ongoing.

Cancer Detecting Sensor Developed

Researchers in Japan develop cancer-detecting sensor

In the future, it may become possible for an individual to easily check their health by connecting a sensor to a smartphone or other device. There are also hopes the world’s growing medical expenditures could be curbed by the early detection of disease.

Now the Japan-based National Institute for Materials Science (NIMS) announced the development of a small sensor capable of detecting substances in a person’s exhalations with high accuracy by analyzing the odor of the breath.

To put this technology into practical use, the institute worked with Kyocera Corp., NEC Corp., Sumitomo Seika Chemicals Co., Osaka University and a precision equipment maker in Switzerland.

A “film” installed in the sensor, which is a tiny chip a few millimeters square, determines whether there are substances peculiar to cancer patients’ breath and calculates whether a person is suspected to have cancer. By just exhaling into the sensor, which is connected to a smartphone or other device, the result can be displayed on the screen of the device in a graph or other form.

NIMS reported the sensor is highly likely to distinguish what kind of cancer a person has if the sensor’s accuracy is improved and data on odor is collected.

Peculiar odors are said to be found in the respiration of patients who are suffering from diabetes, kidney and liver diseases, asthma, and those with Helicobacter pylori. The sensor may make it possible to judge what kind of diseases people have, and it is being considered for use not only for examinations at medical institutions but also for self-checks by individuals.

The sensor costs a few hundred yen — the equivalent of a few U.S. dollars — to make and can be produced in large quantities. It is expected to take about six years to develop for practical use in order to collect data on the odors associated with various cancers, improve the sensor’s precision and have it certified as medical equipment by the government, the developers noted.

Cancer is the leading cause of death among Japanese people, with nearly 400,000 people dying each year. According to a 2014 survey by the Cabinet Office, the medical examination rate for cancer screening in Japan is about 40 percent — about half that in the United States and some European nations.

Major reasons cited for not receiving cancer screening in the survey were having no time; the cost involved; and feeling uneasy about pain. Examinations of people’s exhalations would likely improve the medical examination rate. However, it still would be necessary for people to undergo further examinations at medical institutions to confirm whether they have a disease.

“It’ll be epoch-making if such a simple examination of exhalations becomes widely available,” said Nippon Medical School Professor Masao Miyashita, an expert on digestive surgery and cancer.

Robotic Glove Invented

Robotic Glove Invented By NUS Researchers Helps Patients Restore Hand Movements

Patients who have lost their hand functions due to injuries or nerve-related conditions, such as stroke and muscular dystrophy, now have a chance of restoring Robotic Glove their hand movements by using a new lightweight and smart rehabilitation device called EsoGlove developed by a research team from the National University of Singapore (NUS).

Made of soft materials, this novel device is an improvement from conventional robotic hand rehabilitation devices as it has sensors to detect muscle signals and conforms to the natural movements of the human hand, reducing discomfort and risk of injury. This robotic glove is also compact and portable, so patients who are recovering at home or are bedridden could carry out rehabilitation exercises with greater ease and comfort.

Assistant Professor Raye Yeow from the NUS Department of Biomedical Engineering, who specialises in soft wearable robotics and is a key member of the research team, explained, “For patients to restore their hand functions, they need to go through rehabilitation programmes that involve repetitive tasks such as gripping and releasing objects. These exercises are often labour intensive and are confined to clinical settings. EsoGlove is designed to enable patients to carry out rehabilitation exercises in various settings – in the hospital wards, rehabilitation centres and even at home. Equipped with technology that can detect and interpret muscle signals, EsoGlove can also assist patients in daily activities, for instance by guiding the fingers to perform tasks such as holding a cup.”

The NUS team comprises Asst Prof Yeow, his clinical collaborator Dr Lim Jeong Hoon from the NUS Department of Medicine, as well as PhD candidate Mr Yap Hong Kai and undergraduate student Mr Benjamin Ang Wee Keong, who are both from the NUS Department of Biomedical Engineering.

Greater comfort and convenience

Conventional robotic devices for hand rehabilitation consist of rigid electromechanical components, which are heavy and uncomfortable for patients.

“EsoGlove is unique as it is made entirely of soft components and does not require complicated mechanical setups. The main body of the glove is made of fabric, with soft actuators embedded. It also has adjustable Velcro straps to cater to different hand sizes,” Asst Prof Yeow said.

EsoGlove is connected to a pump-valve control system that modulates the air pressure which directs the soft actuators. When the actuators are pressurised by air, they apply distributed forces along the length of the finger to promote finger movements, such as bending, extending and twisting, to support different hand motions. This novel method does not constrain the finger’s natural movements, unlike conventional devices that make use of rigid links and joints. Each actuator also functions independently, providing assistance to each finger separately.

The robotic glove can be applied in a table-top version for bedridden patients, as well as a waist-belt version for patients who are mobile and recovering at home.

Smart control and assistance

EsoGlove uses an intuitive control mechanism that involves the coupling of electromyography and radio-frequency identification technologies. With this feature, the robotic glove can detect a patient’s intent to perform a hand action on a particular object, such as picking up a pen or holding a mug. By interpreting the muscle signals of the wearer, the robotic glove can help the patient move the fingers to accomplish the specific tasks, involving objects of various shapes and sizes, in an intuitive manner.

Said Dr Lim, who is also a Senior Consultant at the National University Hospital’s Division of Neurology, “With this unique approach, we can develop therapeutic tools using safe and wearable robotic technology. Patients can take the initiative in their own rehabilitative process, rather than being passive recipients of therapists’ intervention.”

“As the soft actuators in the EsoGlove are made from non-ferromagnetic materials, they are suitable for use in functional magnetic resonance imaging studies. We hope that the robotic glove can contribute towards investigating the brain’s activity in relation to motor performance during hand rehabilitation, and unravel the functional effects of soft rehabilitation robotics on brain stimulation,” added Mr Yap, who is also from the NUS Graduate School for Integrative Sciences and Engineering.

Clinical studies and commercialisation

Asst Prof Yeow and his team plan to start pilot clinical studies at the National University Hospital in February 2016 to validate the device’s performance, as well as to obtain patient and clinical feedback so as to further refine the design of the device. The studies will take about six months, involving 30 patients.

The team has also filed a patent for EsoGlove, and will start a spin-off company to commercialise the device.

New Touchless Device to Detect Heart Problems Early

The device is the first portable system that monitors a patient’s blood flow at multiple arterial points simultaneously and without direct contact with the skin.

A revolutionary new system for monitoring vital signs has been developed by researchers that could lead to improved detection and prevention of some cardiovascular issues.

Using patent-pending technology called Coded Hemodynamic Imaging, the device is the first portable system that monitors a patient’s blood flow at multiple arterial points simultaneously and without direct contact with the skin.

It is ideal for assessing patients with painful burns, highly contagious diseases, or infants in neonatal intensive care whose tiny fingers make traditional monitoring difficult.

“Traditional systems in wide use now take one blood-pulse reading at one spot on the body,” said Robert Amelard, a PhD candidate at the University of Waterloo in Canada.

“This device acts like many virtual sensors that measure blood-flow behaviour on various parts of the body. The device relays measurements from all of these pulse points to a computer for continuous monitoring,” said Amelard.

Continuous data collection at different parts of the body provides a more complete picture of what is happening in the body.

Whole-body imaging opens doors for advanced monitoring that can not be done with the traditional, single-point methods, researchers said.

“Since the device can also scan multiple patients individually at once and from a distance, consider the potential in mass emergency scenarios or long-term care homes,” said Professor Alexander Wong, of the Faculty of Engineering at Waterloo and Canada Research Chair in Medical Imaging Systems.

“This technology provides for a more predictive approach to monitor vitals and the potential for its use is extensive, such as indicating arterial blockages that might otherwise go undetected, or warning older adults who risk falling as a result of getting dizzy when they stand,” said Wong.