Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
NATIONAL REIMBURSEMENT
INSIGHTEC receives national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
HAIFA, Israel and MIAMI, Sept. 1, 2020 -- INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that it has received national reimbursement from the Japanese Ministry of Health, Labour and Welfare (MHLW) for treating Parkinson's Disease.
Parkinson's Disease is a progressive neurodegenerative disorder with an incidence in Japan of 1 in 100 people above the age of 60, based on a survey conducted by MHLW. INSIGHTEC's Exablate® Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is performed under Magnetic Resonance Imaging (MRI) guidance for real-time treatment monitoring.
"Parkinson's Disease patients now have a new incisionless surgical treatment option, focused ultrasound," commented Professor Takaomi Taira, Director of Stereotactic and Functional Neurosurgery, Department of Neurosurgery, Tokyo Women's Medical University (TWMU), Tokyo, Japan. "Using focused ultrasound we can precisely target and treat the brain regions which contribute to improvements of the patient's symptoms."
Exablate Neuro is approved for targeting the thalamus for treating Tremor-dominant Parkinson's Disease, and the globus pallidum for treating advanced Parkinson's Disease in patients suffering from mobility, rigidity, or dyskinesia symptoms.
"Japan is the first country in the world to cover focused ultrasound for Parkinson's Disease with nationwide public health insurance," commented Maurice R. Ferré MD, INSIGHTEC CEO and Chairman of the Board of Directors. "This is a major milestone for patients with Parkinson's Disease across Japan."
The Exablate Neuro device received MHLW approval for the treatment of medication-refractory essential tremor and National Health Insurance coverage in June 2019 and received a pre-market approval (PMA) for the treatment of Parkinson's Disease in January 2020. There are currently 12 medical institutions in Japan performing the MR-guided focused ultrasound treatment for essential tremor on a routine basis.
"This extended coverage by the National Health Insurance provides an incisionless treatment option for Parkinson's Disease patients," said Yair Bauer, Country Manager, INSIGHTEC Japan. "This adds to the existing coverage for treatment of tremor from essential tremor and Parkinson's Disease," he added
About INSIGHTEC Japan K.K.
INSIGHTEC Japan K.K. is a subsidiary of INSIGHTEC LTD. The company is the regulatory market approval holder of Exablate Neuro (Exablate 4000) and its distributor in Japan. Founded in 2005, its mission is to provide focused ultrasound treatments for neurosurgery and women's health indications, in order to significantly improve the quality of life for patients in Japan. For more information please visit: www.insightec.com/JP
About INSIGHTEC
INSIGHTEC is a global medical technology innovator transforming patient lives through incisionless brain surgery with MR-guided focused ultrasound. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo.
For more information, please visit: www.insightec.com
https://www.insightec.com/whats-new/press-releases/2020/insightec-receives-national-reimbursement-from-mhlw-for-treating-parkinsons-disease
Israeli scientist uses microbubbles to explode cancer cells
Low-frequency ultrasound bursts microscopic bubbles injected into tumors; explosion kills the majority of the surrounding cancer cells.
By Naama Barak AUGUST 9, 2020, 8:00 AM
An international team of researchers led by an Israeli scientist has developed a noninvasive technology to kill breast cancer cells, an innovation that in the future could perhaps also be used to treat diseases such as brain cancer, Alzheimer’s and Parkinson’s.
The groundbreaking technique, developed by Tel Aviv University’s Tali Ilovitsh during her post-doctorate period at Stanford University, uses low-frequency ultrasound to burst microscopic tumor-targeted bubbles. Her research was recently published in the journal Proceedings of the National Academy of Sciences.
“Microbubbles are microscopic bubbles filled with gas, with a diameter as small as one-tenth of a blood vessel. At certain frequencies and pressures, soundwaves cause microbubbles to act like balloons: microbubbles expand and shrink periodically, and thus allow an increased transfer of substances from the blood vessel to the surrounding tissue,” Ilovitsh explained.
“We discovered that using lower frequencies than those applied before causes microbubbles to expand drastically until they explode. We understood that this discovery can be used as a tumor-treatment platform and started injecting microbubbles into tumors directly.”
Two-pronged approach
The research team injected microbubbles into tumors in engineered mice. The microbubbles were tumor-targeted, meaning that they attached to the tumor cells’ membranes at the moment of explosion.
“Around 80 percent of tumor cells were killed in the explosion, which is already positive,” Ilovitsh says. “The targeted treatment, which is safe and cheap, managed to destroy most of the tumor.”
And yet, to prevent the cancer from spreading, the researchers needed to destroy every cancer cell.
“That is why we injected an immunotherapeutic gene alongside the microbubbles, which acts as a Trojan horse and signals the immune system to attack the cell,” Ilovitsh said.
This gene that alerts the immune system to attack normally cannot enter cancer cells. Introduced by the exploding microbubbles, it managed to enter the cells that were not killed by the explosion and signal to the body that they were cancerous.
“The cancer cells were hit by the explosion, and through the holes that were created the gene we inserted into the microbubbles was transferred inside. Cancer cells that managed to heal and close themselves absorbed the gene that makes them produce a substance alerting the immune system to attack the cell,” Ilovitsh explained.
“In fact, our model mice had tumors on both sides of the body. Despite the fact that we injected microbubbles only to the tumor on one side, the immune system attacked the other side as well,” she relates.
Ilovitsh intends to use the technology that she developed as a noninvasive treatment for brain-damaging diseases such as Alzheimer’s, Parkinson’s and brain tumors.
“The blood-brain barrier does not allow medications to pass through, but microbubbles can expand and enable a temporary opening of the barrier, thus letting the treatment reach its target without requiring an operation,” she said.
https://www.israel21c.org/israeli-scientist-uses-microbubbles-to-explode-cancer-cells/
Gantz says Israel to start human trials of coronavirus vaccine in September
The defense minister says the phase 3 clinical trial is set to begin after the
Jewish High Holidays at Institute for Biological Research in Ness Ziona;
there are currently 4 potential vaccines in the world that reached human trials
Yoav Zitun|
Published: 08.06.20 , 15:27
Defense Minister Benny Gantz said on Thursday an Israeli research institute will begin human trials on a potential coronavirus vaccine after the Jewish High Holidays in September.
Gantz visited the Israel Institute for Biological Research in Ness Ziona earlier in the day, where the director of the institute, Prof. Shmuel Shapira, updated him on the progress in the development of the potential vaccine.
"The successful preliminary trials raise much hope," said Gantz. "The next step, as agreed, is the beginning of human trials after the High Holidays. This will be done in coordination with the Health Ministry and according to all medical safety requirements."
Prof. Shapira praised the defense and health ministries as well as the Prime Minister's Office's cooperation with the institute and said although they are yet to conduct the safety and efficacy trials, Israel already has "a product in hand".
https://www.ynetnews.com/health_science/article/H1O4dwFWw
A wee bit too early to make an announcement of the likes!
Studies show pomegranate supplement slows neurodegenerative diseases
Israel-developed GranaGard is proving in study after study to have remarkable antioxidative effects on cell health for people with MS, Alzheimer’s and even aging.
https://www.israel21c.org/studies-show-pomegranate-supplement-slows-neurodegenerative-diseases/
By Abigail Klein Leichman AUGUST 2, 2020, 8:50 AM
Everybody knows that the pomegranate is a superfood. One of the seven native fruits of Israel, pomegranates are packed with health-promoting and healing antioxidants and vitamins.
Now, an Israeli supplement derived from pomegranate seed oil has proven helpful in improving cognitive function in multiple sclerosis patients experiencing cognitive difficulties associated with the disease.
Prof. Dimitrios Karussis, the internationally renowned director of the Multiple Sclerosis Center at Hadassah-Hebrew University Medical Center in Jerusalem, found significant improvement in learning ability and text comprehension, word recall and categorization in 30 patients involved in a groundbreaking study of the patented GranaGard supplement.
This is just the latest study showing benefits of this over-the-counter supplement. It is not a cure — nerve cell damage is irreversible – but GranaGard seems to prevent or slow neurodegeneration and even reduce symptoms caused by neurodegenerative diseases or aging.
The story behind GranaGard begins with Hadassah senior researcher Ruth Gabizon, an experimental neurologist.
Several years ago, Gabizon had great results using an Israeli face cream from Lavido containing pomegranate seed oil. She learned that the active ingredient in the oil is punicic acid, a powerful antioxidant.
Hadassah senior researcher Prof. Ruth Gabizon. Photo by FLASH90
She wondered how this unique polyunsaturated fatty acid (also known as Omega 5) might help her engineered lab mice, which are predisposed to developing the fatal neurodegenerative disorder Creutzfeldt-Jakob disease.
Hoping to prevent the oxidation that causes permanent neuron damage triggering such diseases, Gabizon had been seeking a safe, inexpensive lipid-based antioxidant to protect brain cells. Punicic acid seemed a good candidate.
“I came into my lab one morning and said to my students, ‘We’re going to give this to our transgenic mice,’” Gabizon told ISRAEL21c in an interview in 2018.
Normally, oils don’t get past the liver. To make the pomegranate seed oil bioavailable to the brain, Gabizon turned to nanotechnology expert Shlomo Magdassi of Hebrew University’s Casali Center for Applied Chemistry. Magdassi met that challenge by breaking the oil down into nanodrops that travel easily through the bloodstream.
Nanotech expert Prof. Shlomo Magdassi of Hebrew University. Photo by FLASH90
The formula’s preventive effects in Gabizon’s mice so impressed Magdassi and Gabizon that they’ve both taken it for the past four years as a general wellbeing tonic.
In late 2016, the two scientists cofounded Granalix Biotechnologies to market the formulation as a food supplement.
Made with punicic acid-rich pomegranate seed oil from Israeli sources, GranaGard is manufactured by Israel’s SupHerb as a soft gelcap. The product is sold worldwide through the Granalix website, through distributors in South America and Europe, and in select Israeli pharmacies.
Cracking the mysteries of pomegranate seed oil
Gabizon’s lab has researched and published studies on the mechanism of GranaGard.
A paper in Nature explains that the liver converts punicic acid from pomegranate seed oil into conjugated linoleic acid (CLA), a strong antioxidant known to inhibit an enzyme associated with the onset of neurodegenerative diseases such as Alzheimer’s.
“In the brains of people with neurodegenerative diseases, the mitochondria – the energy center of the cell – is stressed,” Gabizon explains. “The antioxidant restores mitochondrial activity to a normal level.”
GranaGard by Granalix BioTechnologies. Photo by Efrat Eshel
Furthermore, GranaGard significantly lowered amyloid-beta protein in the brains of mice engineered to develop Alzheimer’s disease, preventing the formation of harmful plaques associated with the disease.
Human trials in Alzheimer patients are planned. “We are starting a 12-month study on minimal cognitive impairment at the Memory Clinic at Rambam Health Care Campus in Haifa,” says Gabizon.
A test of GranaGard on a model of mice predisposed to multiple sclerosis is what led to the Karussis study this year.
“He suggested to test it on cognition in MS patients,” Gabizon tells ISRAEL21c.
“In the last few years, there is a great improvement in managing the physical symptoms of MS with new drugs, but the decline in cognition that affects about half of MS patients is not touched by any of these new drugs and that’s surprising.”
Memory improvement
The Karussis study gave 15 patients a placebo and 15 patients GranaGard for three months. The groups were switched for the following three months. Memory and cognition were tested at zero, three and six months.
“It turns out those who got GranaGard from the beginning showed improvement in memory, not just in stopping the decline,” says Gabizon.
That improvement lasted through the second three months, when they were receiving a placebo. Those who received GranaGard in the second three months only showed improvement in that second stage of the trial.
“In addition to cognitive improvement, they all had more energy because of the effect on the mitochondria,” she adds. “This trial represents a scientific breakthrough in treating cognitive impairment resulting from brain cell destruction using natural antioxidants.”
A further study will be done on MS patients with early memory impairment, says Gabizon.
Dr. Panayiota Petrou, a neurologist who works with Karussis, says they also want to see whether GranaGard can give additional benefits to MS and ALS patients receiving an experimental stem cell treatment.
Keeping our brains alive
Based on her successful original experiment with a mouse model of Creutzfeldt-Jakob disease, Gabizon has been studying GranaGard’s effects in people.
“A large group of family members of genetic Creutzfeldt-Jakob disease patients have been taking GranaGard as a preventive treatment for four years. Until now, none of them – including a lot at the ages at risk — have presented signs of disease. This is encouraging but we need more time to establish statistical significance,” Gabizon says.
Another study will look at GranaGard’s potential as a natural alternative to the diabetes drug metformin, which many people are using to lessen impacts of aging and neurological aging.
“Metformin has side effects because it’s not a natural product,” says Gabizon.“We will do a study comparing metformin to GranaGard.”
She adds that the coronavirus pandemic makes this possible use of GranaGard especially relevant because of the devastating effects of lockdown on elders.
“So many people are at home, and the confinement and social deprivation can cause cognitive decline. We need to keep our brains alive,” she says.
Israel-US team find drug that can stop Covid-19 in its tracks
Researchers show coronavirus causes lungs to accumulate fat, so cholesterol-lowering drug may help downgrade virus threat to that of common cold.
By ISRAEL21c Staff JULY 14, 2020, 7:00 PM
Could a well-known cholesterol-lowering drug help treat Covid-19? A research team led by Hebrew University of Jerusalem Prof. Yaakov Nahmias says that early research looks promising.
Over the last three-months, Nahmias and Dr. Benjamin tenOever at New York’s Mount Sinai Medical Center have focused on the ways in which the SARS-CoV-2 (the coronavirus that’s causing our current pandemic) changes patients’ lungs in order to reproduce itself.
https://www.israel21c.org/downgrading-covid-19s-threat-to-that-of-the-common-cold/
Interesting.
INSIGHTEC's MR-Guided Focused Ultrasound Treatment for Essential Tremor Receives Complete Medicare Coverage in the US
This coverage impacts an estimated 40 million Medicare Part B beneficiaries
MIAMI, July 13, 2020 /PRNewswire/ -- INSIGHTEC, a global medical technology innovator of incisionless surgery, announced today achievement of complete Medicare coverage across all 50 states for MR-guided focused ultrasound treatment of medication-refractory Essential Tremor.
"INSIGHTEC is committed to expanding patient access for MR-guided focused ultrasound," said Dee Kolanek, INSIGHTEC Vice President of Reimbursement. "The efforts of our team have made complete Medicare coverage a reality by working closely with the seven Local Medicare Administrative Contractors over the last 18 months."
Compelling clinical evidence and support from physicians, specialty societies and patients led to positive coverage decisions in the final two jurisdictions, resulting in full Medicare coverage across the country.
"Complete Medicare coverage is a significant milestone for INSIGHTEC and brings the incisionless treatment option to millions of people," commented Maurice R. Ferré MD, INSIGHTEC'S CEO and Chairman of the Board of Directors. "This is the critical next step in our mission to make focused ultrasound a standard of care to improve the lives of people living with a challenging condition."
Essential Tremor is a movement disorder affecting an estimated ten million Americans. INSIGHTEC's MR-guided focused ultrasound has been FDA-approved since 2016 for the treatment of medication-refractory Essential Tremor. The treatment is performed with INSIGHTEC's Exablate Neuro platform, which delivers ultrasound waves to precisely ablate the target tissue with no incisions necessary. Many patients show immediate tremor relief with minimal complications. There are 22 treatment centers in the United States currently treating patients on a regular basis.
In addition to Medicare, 22 independent Blue Cross Blue Shield Association plans offer focused ultrasound treatment for medication-refractory Essential Tremor as a covered benefit.
https://www.prnewswire.com/news-releases/insightecs-mr-guided-focused-ultrasound-treatment-for-essential-tremor-receives-complete-medicare-coverage-in-the-us-301092200.html
13 promising Covid treatments emerging from Israel
In parallel to vaccine research, there’s an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus
.
By Abigail Klein Leichman JULY 6, 2020, 7:50 AM
Scientists across the globe are working on vaccines to prevent Covid-19 infection. (Click here to read about six Israeli vaccine candidates.)
But in the meanwhile, and even after initial vaccines are approved, there is an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus.
Most potential treatments target the life-threatening lung inflammation typical of serious Covid-19 cases. It’s caused by a phenomenon called a “cytokine storm.”
Cytokines are proteins that trigger inflammation as a natural response to infection. In response to a virus overload, in this case in the lungs, the immune system activates a storm of cytokines. Too many cytokines lead to too much inflammation, which can damage the lungs and cause respiratory distress.
Israeli hospitals were among the first anywhere to use dexamethasone, a steroid drug, to stop cytokines storms and reduce lung inflammation in severely ill Covid-19 patients. However, steroids can suppress the immune response too strongly.
Additionally, an Israeli hospital is among the first to do a randomized, double-blind, placebo-controlled clinical trial of ivermectin, a drug to treat parasitic infections in people and animals, to see if it can shorten the duration of the disease if given to Covid-19 patients immediately after diagnosis.
Israelis are also formulating novel therapeutics of their own.
Below we summarize 13 potential Israeli treatments using a variety of approaches – such as placenta-derived cells, peptides, blood plasma of recovered patients, and the cannabis compound CBD.
There is plenty of room for more than one treatment.
“We believe humanity needs a toolbox of different solutions for Covid-19,” says Immanuel Lerner, CEO of Pepticom, one of the companies detailed below.
Pluristem
On June 11, Pluristem Therapeutics of Haifa announced a multicenter Phase 2 US Food and Drug Administration (FDA) efficacy and safety study of its PLX-PAD cells for treating severe Covid-19 complicated by acute respiratory distress syndrome (ARDS).
PLX, an injected regenerative placenta-derived cell therapy, stimulates the immune system’s natural regulatory T cells and M2 macrophages, possibly preventing or reversing a cytokine storm. PLX cells potentially reduce the incidence and/or severity of Covid-19 pneumonia and pneumonitis.
Pluristem has treated Covid-19 patients under compassionate use programs in the United States and Israel. Initial data from 18 patients showed that 75% were off mechanical ventilation within 28 days.
“PLX cells are available off-the-shelf and once commercialized, can be manufactured in large-scale quantities, offering a key advantage in addressing a global pandemic,” the company said.
Silkim
Jerusalem-based Silkim Pharma recently submitted Coronzot, its novel treatment for Covid-19 patients with moderate to severe symptoms, to the FDA’s Investigational New Drug (IND) program.
IND designation would give Silkim permission to start human clinical trials and to ship Coronzot across state lines before a marketing application has been approved.
Coronzot’s novel mechanism targets a pivotal factor in cytokine storms. It removes an inflammatory overaccumulation of labile iron and replaces it with a minute amount of gallium or zinc.
This not only suppresses the storm but also inhibits viral proteins that attack the lungs and heart. Gallium inhibits virus replication and promotes apoptosis (self-destruction) of already invaded cells. Zinc helps suppress inflammatory reactions and enzymes that enable coronavirus replication.
The company is actively engaged in the FDA process. “We look forward to finalizing the IND and then moving towards conducting clinical studies of Coronzot for Covid-19,” said Silkim Pharma CEO Dror Chevion.
RedHill Biopharma
RedHill Biopharma, based in Raleigh, North Carolina and Tel Aviv, is “moving rapidly to advance our development program with opaganib for Covid-19,” according to a June 10 statement by Dr. Mark L. Levitt, RedHill medical director.
RedHill acquired opaganib from US-based Apogee Biotechnology, which developed this oral drug to fight cancer, inflammation and viruses.
RedHill has seen encouraging preliminary findings from six Israeli Covid-19 patients given opaganib under compassionate use to reduce lung inflammation. All were weaned from supplemental oxygen and discharged from the hospital without having to receive mechanical ventilation.
RedHill plans a multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study on 270 US patients with severe Covid-19 pneumonia.
“We are expanding the development program to Russia and additional European countries, in parallel with the US clinical study, in order to accelerate the collection of robust data on the potential efficacy of opaganib against Covid-19,” said Levitt.
The company is working with government agencies worldwide to allow more patients access to the investigational drug through clinical studies and compassionate use programs.
InnoCan
InnoCan founders, from left, Ron Mayron, Iris Bincovich, Yoram Drucker. Photo by Rotem Lahav
InnoCan Pharma Israel and Tel Aviv University tech-transfer company Ramot are collaborating to develop a new CBD-loaded exosome technology to fight lung inflammation.
Exosomes, small particles created from stem cells, can act as “homing missiles” targeting specific damaged organs and facilitating cell-to-cell communication.
Combining the cell-healing properties of exosomes with the anti-inflammatory properties of the cannabis-derived compound CBD is expected to have a strong synergetic effect. The treatment is administrated by inhalation.
Stero Biotechs
Stero Biotechs of Bnei Brak has started a small clinical trial at Rabin Medical Center in Petah Tikva on the tolerability, safety and efficacy of a CBD-enhanced steroid treatment for hospitalized Covid-19 patients.
“Steroid treatment is usually the first or second line of treatment for hospitalized patients. CBD enhances the therapeutic effect of steroid treatment and treats the bio-mechanism affected by the virus,” the company explained.
Eybna and CannaSoul
Two Israeli cannabis R&D firms, Eybna Technologies and CannaSoul Analytics, are developing a proprietary terpene formulation for modulating cytokine storms.
Terpenes are organic compounds found in cannabis and other plants. Studies suggest they can be effective antiviral agents.
CannaSoul’s Cytokine Storm Assay (from its Myplant-Bio subsidiary) will aid in optimizing and customizing Eybna’s novel NT-VRL inhaled formulation for treatment and prevention of viral infections in high-risk populations and actively ill patients.
“The FDA considers this assay as a good predictor for cytokine storm response and immunotoxicity, and it is commonly required in the development of biological treatments,” according to CannaSoul Chairman and CSO Prof. Dedi Meiri.
“The NT-VRL formulation intended to be used via inhalation,” said Eybna CEO Nadav Eyal. “This delivery method dramatically increases the terpenes’ bioavailability by directly contacting the infected cells in the respiratory system.”
CannaSoul aims to identify other cannabis molecules capable of suppressing a cytokine storm in response to Covid-19 without completely suppressing the immune system. It is also studying how cannabis molecules could modulate the ACE2 receptor, which allows the virus to inject its genetic expression into human cells.
Kamada
Based in Rehovot, Kamada has begun supplying its experimental plasma-derived Hyperimmune IgG therapy for compassionate use in severe Covid-19 cases in Israel.
The treatment is based on plasma donated by recovered Israeli Covid-19 patients. One critically ill patient at Hadassah Medical Center showed initial improvement after having the experimental IgG therapy but ultimately did not survive.
During the third quarter of this year, Kamada expects to start a Phase 1/2 clinical study in hospitalized Covid-19 patients in Israel and hold a pre-IND meeting with the FDA to expand clinical development in the United States in partnership with Kedrion Biopharma.
Kedrion is collecting plasma from recovered American Covid-19 patients at 23 FDA-approved centers across the United States. This will be used by Kamada to manufacture additional batches of the product.
“To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19,” said Kamada CEO Amir London.
Israel Institute for Biological Research
The government-run Israel Institute for Biological Research (IIBR) announced in May that analogues of two drugs for Gaucher’s disease proved effective against SARS-CoV-2.
This drug cocktail is made up of the FDA-approved Cerdelga and an analogue of a second drug in advanced stages of the approval process.
The IIBR study on cell cultures demonstrated that the two-drug treatment significantly reduced the replication capacity of the coronavirus and the destruction of the infected cell. This potential treatment is currently being tested in animals infected with the coronavirus.
The IIRB also isolated several key coronavirus antibodies that successfully neutralized aggressive coronavirus in lab tests. These could form the basis of a future treatment following further testing.
Pepticom
Based in Jerusalem, Pepticom computationally designs novel peptide drug candidates using artificial intelligence. The company raised $5 million last year.
Three months ago, Pepticom began implementing its proprietary AI technology on various coronavirus proteins to identify novel peptides that inhibit interaction between the spike protein of SARS-Cov-2 and the ACE2 receptor – thereby stopping the virus from entering the cell.
CEO Immanuel Lerner says three such proteins have already been identified and are being validated in the lab.
“Using AI is a fast way to find these peptides, which are less expensive and easier to produce than antibodies,” Lerner tells ISRAEL21c. “Many parties are interested in looking at our results and finding ways to develop this further.”
Bonus BioGroup
In April, Bonus BioGroup initiated a preclinical study of MesenCure, its unique drug for treating acute and life-threatening respiratory distress in coronavirus and pneumonia patients.
MesenCure consists of activated mesenchymal stromal (stem) cells from healthy adult donors. The activation of these MSCs is intended to boost their ability to reduce lung inflammation, promote regeneration of the diseased lung tissue, and alleviate respiratory and other symptoms in the lungs.
The development of MesenCure relies on more than a decade of related experience and technologies that Bonus BioGroup has used in developing its lead product, a tissue-engineered bone graft also based on MSCs.
“With the current coronavirus outbreak, Bonus BioGroup has started tissue culture studies into the potential of these MSCs, further activated, to alleviate inflammation, including in the lungs, and possibly attenuate the cytokine storm in COVID-19 patients,” the company explained.
The preclinical study in several animal models is expected to be completed in the third quarter of 2020. The company said preliminary results indicate that “following the treatment with MesenCure, the microscopic appearance of the treated lungs was similar to a healthy lung, and a significant improvement in additional related parameters was achieved.”
Bonus BioGroup presented these results to 1,800 scientists, physicians, and public opinion leaders at the virtual conference of the International Society for Cell & Gene Therapy in May.
NanoGhost
Technion-Israel Institute of Technology Prof. Marcelle Machluf developed a drug-delivery technology that uses reconstructed mesenchymal stem cells as nano-vesicles to transport medicine directly to a target.
NanoGhost is the startup she established to commercialize the technology, which has proven successful in treating pancreatic, lung, breast, prostate, and brain cancer in mice. The NanoGhost technology has been patented in the United States and Europe, with additional patents pending in India and China.
Now, Machluf is adapting her technology to create decoy NanoGhosts that attract and entrap the coronavirus, making for a less severe infection. She explains it in the video below.
Enlivex
Enlivex Therapeutics of Ness Ziona is developing Allocetra, a novel immunotherapy medication to treat organ dysfunction and acute multiple organ failure associated with sepsis and Covid-19, as well as solid tumors.
Allocetra rebalances a severely unbalanced immune system by engaging with the immune system’s own regulation mechanisms. It is designed to restore safe immune balance following a cytokine storm.
Enlivex is starting to recruit Covid-19 patients in Israel and in the United States to test the potential effect of Allocetra on moderate to severe cases. A patent from the Japan Patent Office is expected during the third quarter of 2020.
Weizmann Institute of Science
Organic chemist Nir London of the Weizmann Institute of Science in Rehovot is co-leading a collaborative project to identify small molecules that can bind to and inhibit a protease enzyme that the SARS-CoV-2 virus needs to reproduce.
London and his research team had previously developed an advanced method for identifying potential inhibitors for numerous proteins.
“So far, we have made close to 800 compounds and tested more than 650 and keep getting closer to sufficiently potent inhibitors,” London tells ISRAEL21c.
These inhibitors will be further investigated for their potential as a starting point for new drugs against the coronavirus.
London is working with researchers from Oxford University, Memorial Sloan Kettering Cancer Center, University of British Columbia, and Californian-based biotech company.
https://www.israel21c.org/13-promising-covid-treatments-emerging-from-israel/
Israeli Covid-19 vaccine successful in hamster test
A single dose of a vaccine developed at the Israel Institute for Biological Research protects Syrian golden hamsters against the disease, paper says.
By ISRAEL21c Staff JUNE 21, 2020, 9:26 AM
A single dose of a SARS-CoV-2 vaccine developed at the Israel Institute for Biological Research provides protection against SARS-CoV-2 proved effective against Covid-19 in Syrian golden hamsters, according to a paper published June 19.
The recombinant VSV-?G-spike vaccine “results in rapid and potent induction of neutralizing antibodies against SARS-CoV-2,” the paper’s authors report.
UNCOVER ISRAEL - Get the ISRAEL21c
Weekly Edition free by emailSign Up Now!
Two groups of hamsters were used in the study. One group received the vaccine before being infected with the novel coronavirus. The other group was not immunized beforehand.
Hamsters that received a single dose of the experimental vaccination didn’t lose body weight as did unvaccinated hamsters in the control group and their lungs “showed only minor lung pathology, and no viral load” while the unvaccinated hamsters had extensive lung tissue damage and high viral loads.
“Taken together, we suggest recombinant VSV-?G-spike as a safe, efficacious and protective vaccine against SARS-CoV-2 infection,” the authors state.
They noted that more than 90 vaccines are being developed rapidly in a variety of countries using a variety of technologies.
“Among them are RNA and DNA vaccines, viral vectored vaccines, recombinant proteins, live attenuated and inactivated vaccines. Currently, none of these candidates have been approved. Here, we designed an rVSV-based vaccine (rVSV-?G-spike), in which the VSV-G protein is replaced with the SARS-CoV-2 S protein, creating a recombinant replicating virus.”
The governmental research institute in Ness Ziona, which normally works on defense projects, has been directing all its efforts toward novel coronavirus research. In collaboration with several partners, the IIBR is developing a treatment and a vaccine as well as a new method to detect the virus through breath analysis.
The vaccine candidate will now have to be tested on larger animals and finally on humans. Meanwhile, a patent application has been filed.
https://www.israel21c.org/israeli-covid-19-vaccine-successful-in-hamster-test/
Covid-19 treatment developed at Israeli research institute
IIBR scientists had good results using an analogue of the FDA-approved Cerdelga and an analogue of a second drug soon to be approved.
By ISRAEL21c Staff MAY 28, 2020, 1:24 PM
Researchers at the Israel Institute for Biological Research (IIBR) announced that analogues of two drugs for Gaucher’s disease are effective against the coronavirus SARS-CoV-2 (Covid-19).
This drug cocktail may also be effective in the case of future viral outbreaks, according to the IIBR, a governmental research institute that normally works on projects for the Ministry of Defense.
As part of its project to identify antiviral drugs and a vaccine for Covid-19, IIBR scientists tested an analogue of the FDA-approved Cerdelga and an analogue of a second drug in advanced stages of the approval process.
The IIBR study on cell cultures demonstrated that antiviral treatment using both drugs led to a significant reduction in the replication capacity of the coronavirus and to the destruction of the infected cell. This, in turn, prevents further cell damage following infection with SARS-CoV-2.
The two drugs are currently being tested for their effectiveness in treating animals infected with the coronavirus.
The mixture proved effective against several strains of viruses, including those that cause influenza and West Nile fever. This indicates their potential in treating future outbreaks of new viruses once they are clinically approved. Using existing, approved drugs may be an effective short-term solution because of the lengthy research and approval processes for new drugs.
---------------------------------------------------------------
The full article on the IIBR study.
https://www.biorxiv.org/content/10.1101/2020.05.18.103283v1
6 coronavirus vaccine developments from Israel to watch
Israeli companies and academies are working feverishly to invent effective inoculations against SARS-CoV-2.
By Abigail Klein Leichman MAY 25, 2020, 7:05 AM
Research groups across the world are using a variety of approaches to formulating vaccines that could protect people from coronavirus SARS-CoV-2 (Covid-19).
Big money and urgent demand are accelerating the normally lengthy process of vaccine development (see our companion story, “In the race for a coronavirus vaccine, first doesn’t mean best,” to read what two Israeli experts have to say about this).
Vaccine candidates from the US, UK, China, Japan and Germany are on the fast track, and Israel has at least six projects on the go. This international effort may lead to multiple products.
“We expect more than one could make it to market,” says Ronald Ellis, an Israel-based consultant to the industry and editor in chief of Human Vaccines & Immunotherapeutics.
Let’s see what vaccine candidates are being cooked up in Israeli labs.
MigVax
David Zigdon, CEO of Migal Galilee Research Institute and interim CEO of MigVax. Photo courtesy of OurCrowd
The new startup MigVax was spun out of Migal Galilee Research Institute in Kiryat Shemona, the largest regional R&D center of the Israeli Science and Technology Ministry.
Over the past four years, Migal developed a vaccine against a coronavirus strain affecting chickens. Safety and effectiveness were proven in animal trials at Israel’s Veterinary institute.
MigVax is translating methods from the poultry vaccine program to develop an oral human vaccine against Covid-19.
This is a “sub-unit” vaccine, containing pieces of coronavirus protein (not live or dead virus) delivered orally to the immune system via a bacterial protein to stimulate antibodies and immune cells against coronavirus in mucosa, blood and cells.
“The experiments we have carried out so far show that because the vaccine does not include the virus itself, it will be safe to use in immune-suppressed recipients, and has fewer chances of side effects,” said David Zigdon, CEO of the Migal Galilee Research Institute and interim CEO of MigVax.
Zigdon said the material could be ready for clinical trials within a few months.
If the trials are successful, MigVax will partner with a GMP (Good Manufacturing Practices) facility to produce the vaccine in mass quantities quickly and at low cost using bacterial fermentation.
On April 22, Jerusalem-based OurCrowd venture investment platform announced a $12 million funding round in MigVax.
IIBR
The Israel Institute of Biological Research, a Defense Ministry laboratory in Ness Ziona, has reportedly completed successful Covid-19 vaccine trials on rodents.
The vaccine candidate will now be tested on other animals for safety and efficacy and then, if successful, would be tested in humans, according to Israeli media.
The IIBR did not release any official statement about its vaccine progress.
However, Chief Innovation Coordinator Eran Zehavy previously said the institute is also developing an antibody-based treatment for Covid-19 using plasma from recovered patients. He said this treatment is expected to take less time to develop than the vaccine.
Earlier this month, the IIBR isolated a key coronavirus antibody that successfully neutralized aggressive coronavirus in lab tests. Since then, the institute filed patent applications for eight separate coronavirus antibodies it has isolated.
TransAlgae
TransAlgae in Rehovot has opened a $5 million investment round to support development of an oral sub-unit coronavirus vaccine in pill form.
The essence of this vaccine candidate is an edible delivery vehicle based on engineered algae.
Bioencapsulated inside the algae, a specific coronavirus protein molecule travels intact through the digestive system to stimulate its target, the immune system.
Eyal Ronen, VP for business development, says TransAlgae invested over $25 million over the past 11 years in developing this technology for animal and fish vaccines as well as crop insecticides.
“We are not a pharma company and were not interested in going into human health at this moment. But our shareholders were asking us, why not use this for human beings? We took the challenge,” says Ronen.
“Our algae for this project are genetically modified so they can grow in a fermenter, like yeast, for low-cost mass production. This increases production rate 30-fold over wild algae. And we can control all the inputs in an accurate way for consistency,” says Ronen.
With mouse trials to begin in a few months, TransAlgae is seeking collaborations and strategic partnerships with American companies to advance development.
University vaccine research
Israel’s academic labs are also contributing to Covid-19 vaccine research. The Israeli Council for Higher Education announced a $4 million KillCorona grant fund to support research on preventing, diagnosing and treating Covid-19.
Tel Aviv University Prof. Jonathan Gershoni recently received a US patent on a coronavirus vaccine design that his lab spent 15 years developing.
TAU technology-transfer company Ramot signed a research and license agreement with Swiss biopharmaceutical company Neovii to develop a Covid-19 vaccine based on Gershoni’s design.
His lab isolates and reconstructs the receptor binding motif (RBM), a critical structure of the coronavirus “spike” protein that enables the virus to infect a target cell.
“The moment the genome of the new virus was published in early January 2020, we began the process of reconstituting the RBM of SARS CoV2, the virus that causes Covid-19,” Gershoni said.
“The virus takes far-reaching measures to hide its RBM from the human immune system, but the best way to ‘win the war’ is to develop a vaccine that specifically targets the virus’s RBM.”
Bar-Ilan University Faculty of Medicine scientists from Moshe Dessau’s Structural Biology of Infectious Diseases Lab are developing a system of harmless viruses, containing components such as the coronavirus envelope protein, to test their response to substances including vaccine candidates.
Working in collaboration with a Swedish pharmaceutical company, Dessau’s lab aims to contribute valuable information for vaccine development and for testing drugs that may inhibit the virus.
Technion-Israel Institute of Technology researcher Avi Schroeder, head of the Targeted Drug Delivery and Personalized Medicine Group, is developing a Covid-19 vaccine based on his novel immune-boosting food additive that protects farmed shrimp from viral infection.
“Viruses infect us by multiplying inside our cells and to do this the virus produces proteins,” Schroeder says, describing a process called RNA interference. “We stop the production of these proteins inside the body.”
https://www.israel21c.org/6-coronavirus-vaccine-developments-from-israel-to-watch/
PSTI -Positive top line results from IC Phase 2 Study.
Congratulations KTOV (and longs, me included)
Hurrrray KTOV.
Bon chance
Mazzel Tov.
KTOV-Kitov Pharmaceuticals Announces Phase III/IV Clinical Trial for KIT-302 Successfully Meets Primary Endpoint, and also Demonstrates Drug Candidate Improves Renal Function
#msg-135723422
I do not follow
ZION oil, hence
no idea!
This board contains various
Israeli companies.
Hebrew U tech chief seeks balance between academia and industry
Yaron Daniely, the new head of Hebrew University's tech transfer unit, wants technology created in the academic world to get a fair chance to market
By SHOSHANNA SOLOMON
September 13, 2017, 11:46 am
https://www.timesofisrael.com/hebrew-u-tech-chief-seeks-balance-between-academia-and-industry/
Coming of age, Israel biotech sector gets ready for market.
After billion-dollar NeuroDerm sale, life science firms Gamida Cell, BiondVax, RedHill and Vascular Biogenics are gearing up for commercialization
BY SHOSHANNA SOLOMON August 17, 2017, 12:44 pm
The sale of Israeli drugmaker NeuroDerm to Japanese pharma giant Mitsubishi Tanabe for $1.1 billion last month in the largest ever purchase of an Israeli healthcare company, has put the spotlight on Israel’s biotech sector, where a number of other firms are gearing up for commercialization of their product.
http://www.timesofisrael.com/coming-of-age-israel-biotech-sector-gets-ready-for-market/
“This is a big deal,” said Anya Eldan, vice president of the Israel Innovation Authority’s Startup Division, about the NeuroDerm deal. “We don’t see this kind of valuation often for a biotech company; it is more typical of an internet company. It shows big support for the Israeli biotech industry.”
NeuroDerm develops treatments for patients suffering from Parkinson’s disease, as well as other disorders related to the central nervous system.
The firm’s leading product candidate is not even on the market yet, but is in advanced clinical trials in both Europe and the United States. The product could hit the market as early as 2019, Mitsubishi Tanabe said last month.
NeuroDerm was founded in one of the Innovation Authority’s technological incubators in 2003 and received the authority’s financial support for seven years, Eldan said. “It is very gratifying that one of our companies has done so well. The company now has a strategic partner that will help bring its product to the market.”
Biotechnology firms typically have a long and painful journey to success. Much money and patience and a lot of luck is needed to develop a drug, a process that takes years and goes through identifying a need, getting an idea for a drug, developing the drug and then undertaking clinical trials that may ultimately lead to regulatory approvals worldwide and commercialization. The chances of failure at each of these stages is huge. And little successes bring much joy.
“In biotech, it is very difficult to succeed, and building an ecosystem in Israel requires patience,” said Eldan.
The NeuroDerm deal, she said, “is the beginning of the coming of age of the Israeli biotech industry, and it is the result of a long-term government policy. We are very happy to see this kind of maturation, and there is still a lot of work to do.”
But, she added, “eventually out of these young innovative companies the next big Israeli pharma firm will emerge.”
An active biotech scene
There are some 1,350 life sciences companies active now in Israel, 612 of them having been created in the last decade, 2007-2016, according to a 2016 Life Sciences Report by the Israel Advanced Technology Industries (IATI) released in May. The IATI is an umbrella organization of the high-tech and life sciences industries in Israel.
Some $823 million flowed into the industry last year, accounting for 20% of all investments in Israeli high-tech, the report showed. And the industry is becoming more mature, with some 33% of companies in preliminary revenue phase, and 5% in the revenue growth stage.
Indeed, companies like BiondVax, a developer of a universal flu vaccine candidate; Gamida Cell, a maker of cell and immune therapy technologies; RedHill Biopharma Ltd, a developer of drugs for gastrointestinal diseases; and Vascular Biogenics Ltd. (VBL), a maker of drugs that targets blood vessels to stop the spread of cancer are all gearing up toward commercialization of their products.
Getting ready to sprint
RedHill Biopharma, the biotech company founded by two kibbutz dwellers, Dror Ben-Asher and Ori Shilo, is traded both in Tel Aviv and on the Nasdaq. The firm is conducting late-stage clinical trials for several drugs, including two that aim to tackle Crohn’s disease and H. pylori, the bacteria that is the root of ulcers and a major cause of gastric cancer, respectively.
RedHill also has a pipeline of other advanced clinical-stage experimental medications in the works, as a way to spread out risk.
RedHill is currently setting up its US commercial infrastructure and salesforce, headquartered in Raleigh, North Carolina, as it waits for its other products to ripen and get the potential approvals needed from the US FDA.
Vascular Biogenics, founded in 2000 by its CEO Dror Harats, a professor at Tel Aviv University and a doctor at the Sheba Medical Center in Ramat Gan, develops anti-cancer gene therapies. Its flagship drug, VB-111, targets glioblastoma multiforme, an aggressive and difficult to treat type of brain tumor.
The company plans to set up a new manufacturing facility in Modiin in central Israel, which will bring the company closer to the potential commercialization of the VB-111 drug.
BiondVax, a Ness Ziona-based company whose shares are traded on the Nasdaq and in Tel Aviv, is a developer of a universal flu vaccine candidate.
The company said last month it has signed an agreement to lease a space of approximately 1,800 square meters in the Jerusalem BioPark, located in the Ein Kerem Hadassah Campus. The mid-sized facility is expected to have the capacity to annually produce tens of millions of doses of its flagship M-001 universal flu vaccine candidate, either in single-dose syringe or in bulk. M-001 is designed to provide protection against current and future seasonal and pandemic flu strains.
File: Illustrative photo of a vaccination: Miriam Alster/Flash90)
Illustrative photo of a vaccination (Miriam Alster/Flash90)
“This new planned mid-size commercial manufacturing facility will mark the culmination of BiondVax’s transformation into a fully integrated pharmaceutical company,” operating under international standards, said Dr. Shimon Hassin, BiondVax’s chief operating officer, at the time of the announcement.
Jerusalem-based Gamida Cell has started enrolling patients for a last-stage clinical trial for a drug it believes will help increase the success of bone marrow transplants in blood cancer patients, and help them better withstand the ordeal of the lifesaving procedure. The company hopes that if the trial is successful, it will lead to the launch of a commercially available product in 2020.
“We are at an exciting transition point, and moving from being a research and development firm, based in Israel, to an international commercial firm,” Gamida Cell’s CEO Yael Margolin, who has headed the privately held company for the past 12 years, said in an interview earlier this month. Pharma giant Novartis is one of the investors in the firm.
As shown in the IATI report, over the last decade, Israeli life sciences companies have raised more than $6.7 billion on NASDAQ exchange, with $5 billion raised since 2013. The Nasdaq remains the main source for public offerings for Israeli life sciences companies, with more public offerings and more money raised than on all other exchanges combined, including on the Tel Aviv Stock Exchange (TASE).
The shares of 60 life sciences firms are listed on TASE, the report said, of which 21, like BiondVax and RedHill, are dual-listed on foreign markets. These include biotechnology firms, holding companies that invest in life sciences technologies and firms, medical device companies and pharma companies.
The Israeli government continues to focus on providing a support network for R&D through various programs providing grants and other incentives, the IATI report said.
Mazor Robotics Receives FDA Clearance for Spinal Deformity Correction Planning Software for the Mazor X Surgical Assurance Platform
Business Wire Business WireApril 12, 2017
CAESAREA, Israel--(BUSINESS WIRE)--
Mazor Robotics Ltd. (MZOR.TA)(MZOR), a pioneer and leader in the field of surgical guidance systems, has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.
Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.
According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”
Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.
During AANS, Mazor Robotics will be hosting the following special presentations at booth #1423:
Presentation: Clinical Experience with Mazor Robotics Guidance Systems
Presenter: Dr. Jae Y. Lim
Date: Monday, April 24
Time: 1:00 – 2:00 pm
Presentation: Initial Case Series with Mazor Robotics’ Next Gen System: Mazor X™
Presenter: Dr. Donald M. Whiting
Date: Monday, April 24
Time: 3:30 – 4:00 pm
About Mazor
Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.
BiondVax Approved for Grant from Israel's Ministry of Economy and Industry to Build Facility for Commercial Scale Production of its Universal Flu Vaccine
NESS ZIONA, Israel, March 30, 2017 /PRNewswire/ --
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced that the Israel Investment Center, a unit of the Government of Israel's Ministry of Economy and Industry, approved a grant representing 20% of a NIS 20M budget to be utilized towards the construction of a factory for the production of Phase 3 and commercial batches of BiondVax's universal flu vaccine candidate M-001. The grant is subject to certain terms and conditions including those outlined under the Encouragement of Capital Investment Law 1959.
BiondVax plans to build the mid-sized factory in Jerusalem, with potential capacity to annually produce up to tens of millions of doses of M-001. M-001 is designed to provide protection against current and future seasonal and pandemic flu strains. Five completed Phase 1/2 and Phase 2 human clinical trials have shown the vaccine to be safe and immunogenic to multiple flu strains.
Dr. Ron Babecoff, BiondVax's CEO, commented, "This significant milestone signifies the evolution of BiondVax from a biotech start-up to a pharmaceutical company positioned for significant growth and contributions to society. I would like to thank the Ministry of Economy and Industry for helping translate BiondVax's vision to reality."
Dr. Shimon Hassin, BiondVax's COO noted, "In the past few years BiondVax focused on establishing a small scale GMP facility, one that was approved by the European Union. Our current facility laid the foundation for manufacturing quality excellence that will be implemented in the new factory."
An ongoing Phase 2b trial is being conducted in collaboration with the UNISEC consortium. The research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012. Positive preliminary safety results were announced[1] in November 2016. BiondVax's consortium partners are continuing to analyze study samples. BiondVax expects the consortium will finalize and release results in Q2 2017.
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit http://www.biondvax.com.
--------------------------------------------------
1. http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/
Back to the Future: Study Published in Vaccine Journal Indicates BiondVax's Universal Flu Vaccine Candidate May Cover Strains Which Don't yet Exist
#msg-127810036
Nice Creative Headline!
PLX 42c With Positive Phase 2 Data A Major Partnership Is Just Around The Corner. 12-Mo Target $3/Share
http://seekingalpha.com/instablog/44479986-leny-hettmansperger/4946870-plx-42c-positive-phase-2-data-major-partnership-just-around-corner-12-mo-target-3-share
Jan. 4, 2017 5:42 AM ET|1 comment |Includes:Protalix BioTherapeutics, Inc (PLX)
Investment Highlights:
On January 3, 2016, Protalix Reported positive interim results in a Phase 2 clinical trial assessing AIR DNase (alidornase alfa) in patients with cystic fibrosis (NYSE:CF).
Continued success of AIR DNase (alidornase alfa) suggests that it will become a key treatment for all CF patients unlike other treatments that only benefit a portion of CF patients.
AIR DNase is going after $700M/year Roche's Pulmozyme (dornase alfa) and other FDA-approved drugs. Today's results show significant advantages over Pulmozyme's performance.
Protalix pipeline has a $10B billion addressable market - a drug in Phase 3 to treat Fabry disease, AIRDNase for CF, and another in Phase 2 to treat ulcerative colitis.
The company believes that it is funded through the end of 2019 with current cash on hand and sales of its FDA-approved drug alfataliglicerase to treat Gaucher patients in Brazil.
Discussion:
Protalix BioTherapeutics (NYSE:PLX) is a clinical-commercial biotec company focused on the development and commercialization of recombinant therapeutic proteins based on its proprietary ProCellEx platform. More details about the company can be found in my December 28, 2016 article "Protalix BioTherapeutics Receives $24M Order, Is Well Funded, And Has Significant Upside."
On May 1, 2012 Protalix and its partner Pfizer (NYSE:PFE) announced that the FDA approved ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (NASDAQ:ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. This was the first FDA-approved plant cell-expressed drug that is derived from ProCellEx, Protalix's proprietary manufacturing system, using genetically engineered carrot cells.
David Aviezer, Ph.D., MBA, the then President and CEO of Protalix commented,
"We believe that this great news is a recognition of our technology, which is a plant cell manufacturing system from Protalix. This technology is the production process behind taliglucerase alfa and other plant-based Protalix product candidates using our ProCellEx, proprietary manufacturing system."
At the time of the FDA news PLX traded at $7.6/share corresponding to a market cap of over $500M, or ten times higher than today's fully-diluted market cap.
Protalix Engineered Plant-Based Drugs Are Batting 1000
Protalix, having the first genetically-engineered plant cell-based protein approved by the FDA, has paved the way for its other drugs developed by the company's ProCellEx technology platform.
Let me first review today's positive interim Phase 2 news related to AIR DNase (alidornase alfa) to treat Cystic fibrosis. This phase of the trial is a 28-day switch-over study in cystic fibrosis patients previously treated with $200B Roche's (OTCQX:RHHBY) dornase alfa or Pulmozyme.
Moshe Manor, Protalix's President and Chief Executive Officer commented on the interim results:
"We are enthusiastic about the data generated in this trial as we were able to see meaningful improvements in efficacy in a way that have not been reported for a long time in the challenging CF space. We are looking forward to reporting full results from the study before the end of the first quarter of 2017."
Professor Eitan Kerem, Chairman of Pediatrics, Head of The Cystic Fibrosis Center, Hadassah University Hospital added:
"The preliminary efficacy results of alidornase alfa are very encouraging, even when compared to past trials of approved drugs for the treatment of CF. Although the study was performed on a small number of patients, the data is very encouraging since it shows clinically meaningful results. I look forward to following the results of upcoming trials of alidornase alfa. If the data continues to be as positive, clearly alidornase alfa will be a key treatment for all CF patients."
Key results shared by the company for this interim report were:
Interim Phase 2 data showed that alidornase alfa improved lung function by 4.1 points from baseline as measured by percent predicted forced expiratory volume in one second (ppFEV1). This compares favorably to a mean of 2.5 achieved by a commercially available CFTR modulator.
A mean reduction of approximately 60% in DNA content from baseline in sputa was observed, and a mean reduction of approximately 90% from baseline was observed for sputa visco-elasticity.
No serious adverse events were reported, and all adverse events that occurred during the study were mild and transient in nature.
Before I discuss the importance of the findings above, I believe that it is necessary for investors to understand some basics about Cystic fibrosis.
Cystic fibrosis is a complex disease and the types and severity of symptoms can differ widely from person to person.
In people with cystic fibrosis, a large defective gene or DNA causes a thick, buildup of mucus in the lungs allowing germs to multiply. Lung infections, caused mostly by bacteria, are a serious and chronic problem for many people living with the disease. Additionally, as the patient swallows these secretions, often while they are asleep, the pancreas becomes compromised as it is blocked and unable to secrete enzymes that normally breakdown food and enable the body to absorb vital nutrients. In the liver, the thick mucus can block the bile duct, causing liver disease. Men with cystic fibrosis are often to have children.
The cost of CF to the US economy has been estimated to exceed $20B as CF patients, their relatives, and even friends and coworkers can have their lives adversely affected in many ways.
According to the Cystic Fibrosis Foundation Registry, more than 30,000 people are living with cystic fibrosis in the United States and more than 70,000 worldwide. Approximately 1,000 new cases of CF are diagnosed each year. The majority of CF patients are Caucasians-Americans and estimated to carry the disease 1 in 2,500 to 3,500 individuals.
There are currently two main FDA-approved treatment classes being used to treat cystic fibrosis. One of them is mucus thiners like Roche's (OTCQX:RHHBY) dornase alfa or Pulmozyme, and the other category is known as CFTR modulator therapies represented by ivacaftor (Kalydeco) and lumacaftor/ivacaftor (Orkambi). Together they represent almost $2B in yearly sales with Pulmozyme reportedly representing $700M in 2015 according to estimates by GlobaData.
Protalix AIR DNase is a disruptor CF treatment going head-to-head against Pulmozyme, and indirectly against CFTR treatments.
AIR DNase is a plant cell recombinant form of deoxyribonuclease I (DNase I) with Actin Inhibition Resistance or AIR formulated and engineered exclusively by Protalix scientists. AIR DNase, which is administered via inhalation, cleaves large DNA that accumulates in the lungs causing a viscosity reduction of the sputum making it easier to clear up the lungs of CF patients. AIR DNase was designed to be very stable and resistant to chemical alterations.
It is believed that the molecule used in Pulmozyme tends to binds to actin. The actin-bound dornase alfa becomes enzymatically inactive and therefore unable to breakdown large DNA in CF patients' lungs.
With this background I will now discuss the main two interim results from today's announcement and why I believe AIR DNase is a disruptor treatment that could make a big dent on sales of dornase alfa or Pulmozyme, and ivacaftor (Kalydeco) as well as lumacaftor/ivacaftor (Orkambi).
The easiest comparison of AIR DNase is with Pulmozyme because the mechanism of action is basically the same, to cleave large DNA strands so that the resulting lower intact DNA content in mucus thus reducing mucus viscosity. This in turn makes phlegm and sputum easier to evacuate from the lungs, and also helps prevent swallowing it to minimize liver, pancreas, digestive, and reproduction complications.
The results so far are very dramatic. The ability of AIR DNase to resist actin binding contributed to a 60% reduction in DNA content from baseline in sputa. This is turn cause a mean reduction of approximately 90% from baseline for sputa viscosity. Remember that all these parameters are comparing to Pulmozyme performance. The 90% reduction in sputum viscosity is even better than the one observed in vitro in Phase 1.
There is no direct comparison against Kalydeco and Orkambi because they are different mechanisms used for treating CF. According to the Cystic Fibrosis Foundation,
"CFTR (cystic fibrosis transmembrane conductance regulator) modulator therapies are designed to correct the function of the defective protein made by the CF gene. Because different mutations cause different defects in the protein, the medications that have been developed so far are effective only in people with specific mutations."
Ivacaftor (Kalydeco) is prescribed for people ages 2 and older who have at least one of 10 different mutations in the CFTR gene. The lumacaftor/ivacaftor (Orkambi) combination therapy is prescribed for people ages 6 and older who have two copies of the F508del mutation, which is the most common CF mutation. Neither of these treatments can be administered to all CF patients because they only handle a few mutations of the CFTR gene. Although the concept for these treatments is great in that they attempt to address the root cause of the CF problem they have great limitations.
Common side effects of Kalydeco include: Headache, upper respiratory tract infection (common cold, including sore throat, nasal or sinus congestion and runny nose), stomach pain, rash, nausea, dizziness.
Common side effects of Orkambi include: Shortness of breath and/or chest tightness, Upper respiratory tract infection (common cold, including sore throat, nasal or sinus congestion, and runny nose), nausea, diarrhea, rash, fatigue, abnormal or irregular menstrual periods, increased bleeding, and flu-like symptoms including the flu.
Because AIR DNase will be able to treat any CF patient regardless of what gene mutation is causing cystic fibrosis, it is a possible replacement for Kalydeco, Orkambi, and more directly Pulmozyme. Its improved safety profile is another bonus, particularly over Kalydeco and Orkanbi both having serious side effects.
The company website does an excellent job discussing pegunigalsidase alfa PRX 102 in Phase 3 for the treatment of Fabry disease. The data shown there clearly indicates that this molecule has many advantages over the molecules it aims to replace.
The website describes pegunigalsidase alfa as a "plant cell culture expressed and a chemically modified version of the recombinant alpha-Galactosidase-A protein. Protein sub-units are covalently bound via chemical cross-linking using PEG chains, resulting in a more active and stable molecule than the current available versions. PRX 102 demonstrated enhanced circulatory half-life, with higher enzyme activity in target organs affected by Fabry disease."
Investors will also find excellent information on Phase 2 results of OPRX-106 for the treatment of ulcerative colitis. The website describes this compound as a "plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc), in development for oral administration. When administered orally and while passing through the digestive tract, the plant cells function as a natural delivery vehicle, having the unique attribute of a cellulose cell wall which makes them resistant to degradation compared to proteins produced via mammalian cell expression."
The following slide from the December 2, 2016 company presentation summarizes the status of the current pipeline
(click to enlarge)
In summary, Protalix plant-base genetically engineered molecules have many advantages over their mammal-derived counterparts. The key here is the ProCellEx proprietary platform which I discussed in some detail in my December 28, 2016 article.
Every step of every clinical trial performed thus far, including an already FDA-approved drug, demonstrates the robustness of the company's ProCellEx technological platform. It also shows the ingenuity and vision of the company's scientists to design molecules aimed at overcoming the limitations of currently available FDA-approved treatments.
Valuation
The current $50M fully-diluted market cap is only one tenth of what it was after the company's 1st FDA approved drug. The company now has three programs with high probability of success, one in phase 3 and the other two in phase 2. At the time of the FDA approval, the pipeline was very weak. With almost $80M in cash, expected $40M revenues in 2017, one FDA-approved drug, and three potentially blockbuster drugs in the pipeline, the company should have a market cap of at least $250M. Analysts covering the stock have a STRONG BUY rating on the stock with a $2.4/share price target. This corresponds to a fully-diluted market cap of almost $300M.
The price action after today's Phase 2 announcement was not a complete surprise to me. This is because with Stocktwits and services like that there are many more short-term traders than ever before looking to make "easy money." The buildup of interest in the stock was significant in the last few days, but it was obvious that posters were pretty ignorant about PLX from the comments they were making. Deep-pocketed pro traders saw this and they shorted the stock from the opening bell until they felt that the resistance was great enough that they could not drive the price lower without some risks. This was actually good for long-term holders like myself because I expect strong hands to enter the stock going forward. I've already discussed that institutional buying has been very strong in my December 28, 2016 article. I expect more of this going forward. In fact, I believe that PLX is at point where AMD was at this time of the year last year. I expect the same type of steady upward move for PLX in 2017:
(click to enlarge)
Potential partnerships
Rest assured that the progress that Protalix is making on the clinical end is not going unnoticed by big pharma. Pfizer for instance is already in bed with them with their FDA-approved treatment for GD. Furthermore, PFE owns over 5 million shares of PLX and they think very highly of the Protalix as seen in this video. The other logical partner would be Roche. I don't think they would be happy to lose a $700M high-margin Pulmozyme revenue stream. Company officials already stated that they will be looking for partnerships as soon as Phase 2 Cystic fibrosis results would be known. Their PFE partnership has already yielded over $100M since inception, and the money keeps flowing in as PLX makes the GD product for them.
Conclusions
PLX is grossly undervalued at current prices. I believe the stock performance in 2017 will start resembling AMD's performance in 2017.
It is not often that I can say with confidence "buy this clinical-stage biotec without fear." I say this because the company has stated that they are well funded at least through the end of 2019. And this is not even considering a potential partnership which would extend their runway to commercialize new products significantly. Most biotecs are more than eager to execute one equity raise after another causing the erosion of shareholder value.
The success so far of Phase 2 Cystic fibrosis can not be overstated. This is a significant, highly-disruptive program that I am confident will benefit shareholders greatly in the long run. The two other programs in the pipeline are also on strong footing and they address a combined $6B addressable market.
I expect final Cystic fibrosis Phase 2 results scheduled to be revealed before the end of 1Q 2017 to be a success. I believe this will accelerate the path to a lucrative partnership now that Protalix has more leverage than it did when it entered into a partnership with Pfizer.
Investors interested in investing in PLX shares should read all the risks and uncertainties as detailed in the most recent filings with the SEC, in addition to considering the ones that I've listed above.
Disclosure: I am/we are long PLX.
Protalix BioTherapeutics Announces Positive Interim Results from Phase II Clinical Trial of alidornase alfa (AIR DNase™) for the Treatment of Cystic Fibrosis
CARMIEL, Israel, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX), announced today positive interim results from the Company’s phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF) for the first 13 CF patients enrolled in the study. Fifteen patients have been enrolled in, and are expected to complete, the study. alidornase alfa is a plant cell expressed, chemically modified recombinant DNase enzyme resistant to inhibition by actin, which the Company has specifically designed to enhance the enzyme’s efficacy in CF patients.
The phase II trial is a 28-day switch-over study to evaluate the safety and efficacy of alidornase alfa in CF patients previously treated with Pulmozyme®. Participation in the trial is preceded by a two-week washout period from Pulmozyme® before treatment with alidornase alfa via inhalation.
The initial primary efficacy result shows that alidornase alfa improves lung function as demonstrated by a mean absolute increase in the percent predicted forced expiratory volume in one second (ppFEV1) of 4.1 points from baseline. A commercially available small molecule CFTR modulator for the treatment of CF has reported a mean absolute increase in ppFEV1 of 2.5 from baseline in its registration clinical study. This score was achieved while 74% of the patients participating in the trial of the CFTR modulator were also treated with Pulmozyme® on top of the modulator. While this marketed CFTR addresses a certain mutation applicable to less than 50% of CF patients, alidornase alfa is being developed to treat all CF patients.
Sputa available DNA samples were analyzed for approximately half of the patients. A mean reduction of approximately 60% in DNA content from baseline was observed, and a mean reduction of approximately 90% from baseline was observed for sputa visco-elasticity. This data provides further supportive evidence of improved lung function after treatment with alidornase alfa, as demonstrated by the increase in ppFEV1.
No serious adverse events were reported, and all adverse events that occurred during the study were mild and transient in nature.
“We are enthusiastic about the data generated in this trial as we were able to see meaningful improvements in efficacy in a way that have not been reported for a long time in the challenging CF space,” commented Moshe Manor, Protalix’s President and Chief Executive Officer. “We are looking forward to reporting full results from the study before the end of the first quarter of 2017.”
“The preliminary efficacy results of alidornase alfa are very encouraging, even when compared to past trials of approved drugs for the treatment of CF. Although the study was performed on a small number of patients, the data is very encouraging since it shows clinically meaningful results,” said Professor Eitan Kerem, Chairman of Pediatrics, Head of The Cystic Fibrosis Center, Hadassah University Hospital. “I look forward to following the results of upcoming trials of alidornase alfa. If the data continues to be as positive, clearly alidornase alfa will be a key treatment for all CF patients.”
Protalix BioTherapeutics
Protalix BioTherapeutics Inc. (NYSEMKT: PLX) just finished its final patient enrollment for its Phase 2 clinical trial of AIR DNase (PRX-110) for the treatment of cystic fibrosis. Interim results are expected in the first week of January 2017, with the full results from this mid-stage trial coming before the end of the first quarter of 2017.
Protalix shares were last trading at $0.46 apiece. The stock has a consensus price target of $2.40 and a 52-week trading range of $0.26 to $1.04.
http://247wallst.com/healthcare-business/2016/12/30/7-key-fda-decisions-and-catalysts-expected-in-january-and-february/
Elbit Imaging Ltd. Announces That Gamida Cell Has Received FDA Breakthrough Therapy Designation for Nicord
#msg-125706447
NASH event today to inform investors
Oct 5 2016, 11:21 ET | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.SA subscribers should use their 90-day coupon code SA_Sub16.NASH-related tickers: (NYSE:PFE)(NASDAQ:GALT)(NASDAQ:BLRX)(NASDAQ:GLMD)(NASDAQ:CNAT)(NASDAQ:MNOV)(NASDAQ:RGLS)(NASDAQ:ICPT)(NASDAQ:SHPG)(NYSEMKT:CANF)(NASDAQ:VBLT)(OTCPK:ISLT)(OTCPK:GNFTF)
Allergan's $1.7 Billion Acquisition of Tobira for NASH Drug Sets 1750% Potential Premium on Can-Fite Stock
#msg-125465359
Thanks Roy! Too bad KTOV is
no US company otherwise i
am of the opinion it's price
would be over $ 8 with today's
news and company's prospects!
Hi, Dubi. Are you still long KTOV?
Kitov Reports Successful Results for Additional KIT-302 Pharmacokinetic Bioequivalence Study
TEL AVIV, Israel, September 27, 2016 /PRNewswire/ --
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 has successfully completed an additional pharmacokinetic (PK) bioequivalence (BE) study and once more successfully met the U.S. Food and Drug Administration's (FDA) standards for establishing bioequivalence to the reference drugs. The current study evaluated a lower dosage (2.5 mg) of amlodipine than in Kitov's previous PK bioequivalence study for the KIT-302 product containing 10 mg of amlodipine, the results of which were announced by Kitov on May 10, 2016.
"We are pleased with the results of our additional pharmacokinetic BE study, which brings us closer towards submitting our New Drug Application to the FDA for KIT-302 as planned," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
The study compared the PK of Kitov's combination drug KIT-302 in a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5 mg of amlodipine, indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib capsules and 2.5 mg amlodipine tablets. These evaluations were conducted under both fed and fasted conditions. The results demonstrated that for both the Cmax (the maximum blood level achieved) and Area Under the Curve (the area under the concentration time curve for drug levels), the 90% confidence intervals for both the amlodipine and celecoxib components of KIT-302 were documented to be between 80% and 125% of the values obtained with the off-the-shelf drugs. With these study results, Kitov has again met the FDA standard for demonstrating BE under both fed and fasted conditions.
About KIT-302
KIT-302 is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer's Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer's Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration within the coming months.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.
BioLineRx Announces In-licensing of Novel Treatment for Liver Failure Conditions Under Strategic Collaboration
#msg-125342093
Pivotal Study Results Published in New England Journal of Medicine (NEJM) Confirm Safety and Efficacy of INSIGHTEC's Exablate Neuro System for the Treatment of Essential Tremor
#msg-124763104
Elbit Imaging Ltd. Announces That INSIGHTEC Has Signed a Cooperation Agreement With Siemens
#msg-124529385
Will Pluristem Therapeutics Succeed in CLI Where Sanofi Failed?
http://marketexclusive.com/will-pluristem-therapeutics-inc-nasdawqpsti-succeed-cli-sanofi-sa-adr-nysesny-failed/24337/?icd1
RedHill Biopharma Announces Last Patient Visit in Phase IIa Study with RHB-104 for Multiple Sclerosis
The Phase IIa proof-of-concept study evaluates the safety and potential efficacy of fixed oral dose RHB-104 as an add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (RRMS)
Analysis of the study is ongoing, with top-line final results expected in the fourth quarter of 2016
Previously announced interim results after completion of the 24-week RHB-104 treatment period of the study demonstrated positive safety and efficacy signals and support further clinical development
2016 U.S. and worldwide sales of multiple sclerosis therapies are estimated to exceed $12 billion and $18 billion, respectively
RHB-104 is also being evaluated as a treatment for Crohn's disease with an ongoing first Phase III clinical study (the MAP US study) with interim DSMB analysis expected in the fourth quarter of 2016
#msg-124230833
A company worth following imho.
(I own a bunch)
Coverage of INSIGHTEC's Exablate for Pain Palliation of Bone Metastases Expands to 99.8 Million Members in the US
#msg-124146165
Gamida Cell Announces First Patient with Sickle Cell Disease Transplanted in Phase 1/2 Study of CordIn™ as the Sole Graft Source
CordIn has the potential to be a sole graft source for rare genetic diseases where transplantation is the only clinically established cure
#msg-124144482
RedHill Biopharma Receives Additional U.S. Patent Covering RHB-105 Ahead of Confirmatory Phase III Study for H. pylori Infection
#msg-124017693
BrainStorm Announces Positive Top Line Results from the U.S. Phase 2 Study of NurOwn® in Patients with Amyotrophic Lateral Sclerosis
#MSG-123938587
{I have no holdings in BCLI}
THE U.S. FOOD AND DRUG ADMINISTRATION APPROVES EXABLATE NEURO SYSTEM FOR THE TREATMENT OF ESSENTIAL TREMOR
July 12, 2016
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.
Earlier this year, Exablate was also approved by Health Canada for essential tremor.
“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.
Israel-Ontario Agreements to Promote Advancements in Life Sciences
$3 Million Agreement Will Position Ontario as a Leader in Focused Ultrasound Technology
May 24, 2016 10:15 A.M.Office of the Premier
Premier Kathleen Wynne visited Toronto Western Hospital today to showcase an Ontario-Israel partnership that is bringing new technology to the province to treat neurological disorders such as Parkinson's disease and epilepsy.
This partnership is one of 44 agreements announced during Premier Wynne's mission to Israel and the West Bank. Together, these agreements are valued at over $180 million and are expected to create over 200 jobs in Ontario. The focus of the mission was to spur economic growth and job creation -- particularly in the life sciences, technology and innovation sectors.
The Premier toured the Magnetic Resonance-guided Focused Ultrasound (MRgFUS) Lab at Toronto Western Hospital, which is benefiting from a $3 million Memorandum of Understanding that was signed during the mission.
The agreement, between Israeli-based Insightec and Ontario's University Health Network, will enable Insightec to provide technology to the University Health Network for clinical research and development. This partnership will contribute to making Ontario a world centre of excellence for research and training in the use of focused ultrasound technology and will help create new jobs in Ontario's life sciences sector.
Insightec -- a world leader in focused ultrasound technology -- has developed a unique technology that enables doctors to treat patients suffering from neurological disorders, with no incisions, no implants and no radiation.
Building new relationships and helping businesses compete globally are part of the government's economic plan to build Ontario up and deliver on its number-one priority to grow the economy and create jobs. The four-part plan includes investing in talent and skills, including helping more people get and create the jobs of the future by expanding access to high-quality college and university education. The plan is making the largest investment in public infrastructure in Ontario's history and investing in a low-carbon economy driven by innovative, high-growth, export-oriented businesses. The plan is also helping working Ontarians achieve a more secure retirement.
Quick Facts
The Premier’s first mission to the Middle East, which included a business delegation of around 130 people, ran from May 15 to 20.
Ontario’s life sciences sector is the largest in Canada. It employs more than 61,000 people in approximately 1,900 firms, and generates $8.3 billion in exports. In 2012, Ontario’s life sciences sector generated more than $38 billion in revenue.
In September 2015, Ontario established a new Chief Health Innovation Strategist, William Charnetski, to promote the province’s health technology innovation sector and help new products get to market.
Insightec has two clinics in Toronto, at Toronto Western Hospital and Sunnybrook Hospital.
Additional Resources
Learn about Ontario’s competitive advantages
Quotes
Kathleen Wynne
“This partnership between UHN and Insightec is an exciting opportunity for Ontario to pursue new technology to help people suffering from neurological disorders. It is also an opportunity to position Ontario as a world-leading centre in this field, create jobs and boost the province’s life sciences sector, which is a major contributor to Ontario’s economy.”
Kathleen Wynne
Premier of Ontario
“Introducing a disruptive technology to the healthcare system can only be done in tight collaboration between leading academia and industry. It takes years-long effort to research, develop and educate the healthcare system before making it available for the patient’s benefit. We see this initial collaboration as a starting point since the technology has many more potential applications that can benefit additional neurological diseases.”
Eyal Zadicario
General Manager, Insightec
https://news.ontario.ca/opo/en/2016/05/israel-ontario-agreements-to-promote-advancements-in-life-sciences.html
Methinks KTOV can still
'go places' product-wise.
(If such a term exists)
Health Canada Approves Insightec's Exablate Neuro System For The Treatment Of Essential Tremor
HAIFA, Israel, May 24, 2016 /CNW/ - INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announces today that Health Canada has approved its Exablate Neuro system for the treatment of essential tremor.
INSIGHTEC's Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcomes.
Essential tremor is the most common movement disorder, affecting millions of people worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk.
Exablate Neuro was investigated as a treatment alternative for these patients.
Data presented to Health Canada demonstrated a clinically meaningful effect of the treatment making the disease more manageable and less debilitating. Due to its non-invasive nature, the procedure is performed while the patient is fully conscious, with no incisions and no anesthesia. The results are immediate and the patient is able to return to normal activities within days.
"Thanks to this favorable decision, Canadian essential tremor patients suffering significant disability now have access to a new incision-less treatment option that offers immediate results," said Richard Schallhorn, INSIGHTEC's VP of Neurosurgery. "Previous treatment options for patients who do not respond to drugs have either involved ionizing radiation or have been significantly more invasive involving implanted hardware," he added.
"This is a major breakthrough in the treatment of Essential Tremor," said Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto. "We are excited to offer our patients a new, minimally-invasive therapy to control their tremors and effectively treat their debilitating symptoms. The patients we have treated so far with this technique have had significant relief of their tremor and a very quick recovery with minimal adverse events", he emphasized.
Maurice R. Ferré, MD, CEO and Chairman of INSIGHTEC said, "INSIGHTEC is at the forefront of the global shift towards non-invasive procedures. Ultimately, our goal is to transform medical practices as we know them today and to improve patient outcomes, reduce morbidity and trauma while reducing costs. Health Canada's regulatory approval of our Exablate Neuro technology is an important milestone in our path to fulfilling our mission," said Dr. Ferré.
INSIGHTEC's Exablate Neuro system was CE marked for the treatment of essential tremor, tremor dominant Parkinson's disease and neuropathic pain in 2012 and is currently under FDA review for the treatment of essential tremor. The Health Canada approval includes Exablate Neuro 3T, 1.5T systems and the 1.5 head coil.
About INSIGHTEC
INSIGHTEC is a world leader in MR-guided Focused Ultrasound (MRgFUS). The company, founded in 1999, develops and distributes a non-invasive therapy platform that is transforming medicine. INSIGHTEC is continuously expanding its applications ranging from functional neurosurgery to oncology and gynecology. MRgFUS is embraced by world-renowned physicians in more than 120 leading medical facilities around the world, who value both its clinical and economic value. The company has received numerous innovation awards, including the Wall Street Journal, European Union and TIME magazine among others. For more information, please visit: http://www.insightec.com
I was heavily invested in KTOV
at a $3.40 average level.
Sold most of it and remained
with half my profit in, a
quite pretty penny!
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) Anchors Israeli Takeover?
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) closed the chapter of Israeli IPOs in the U.S. in 2015. But more Israeli technology and biotech companies are expected to list in the U.S. this year depending on market demand. Kitov seems poised to benefit from a surge in interest in Israeli stocks.
According to EVP of Listings Services at NASDAQ, Nelson Griggs, at least three Israel-based companies have already done their initial filing for IPO in the U.S. for this year. Those companies will be looking to enter the U.S. public market when the environment is conducive.
Some four Israeli companies with market value in the band of $500 to $750 million could raise between $75 and $130 million when they IPO in the U.S., according to Griggs. Of the various non-U.S. companies listed on NASDAQ, the majority are based in Canada, China followed by Israel. That’s a sign of appetite for Israeli stocks in the U.S. and more companies in the country are hoping to capitalize on that goodwill to tap in the U.S. investor pool.
Kitov closes chapter on a slow year
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV)’s September 2015 listing in the U.S. closed the chapter of Israeli companies that listed in the U.S. on that year. But the year only saw 7 Israeli IPOs compared to 12 in the previous year. Nevertheless, Kitov shares could edge up as investors show more love for Israeli companies.
Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) beyond the IPO wave
But beyond the IPO wave, Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) has company-specific catalysts that could drive gains in the stock in the next few years. The company recently updated on its clinical programs, saying that a study of its drug candidate called KIT-302 met key FDA standards.
Following the success of the study, Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ: KTOV) said it had moved closer to seeking FDA approval of KIT-302 later this year. The company is also gearing up to bring the drug to market in 2017.
Followers
|
14
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
1367
|
Created
|
09/23/05
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |