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Monthly Archives: April 2022
UI professor to research collaborative regenerative medicine in Ireland – UI The Daily Iowan
Posted: April 19, 2022 at 2:00 am
James Ankrum, a University of Iowa biomedical engineering professor, will bring his expertise in cell biology to a world-renowned research lab in Dublin.
A University of Iowa professor will travel to Ireland for a collaborative effort aimed at advancing research in the field of regenerative medicine.
James Ankrum, UI associate professor of biomedical engineering, was one of over 400 professionals, artists, and scholars who received the competitive Fulbright Scholar Award to fund his journey.
He said his work with the Royal College of Surgeons in Ireland will be an ongoing effort that combines its renowned tissue engineering program with his cell biology expertise to tailor the cells of the body for ailment therapy and relief.
This isnt just a six-month [thing], where we work together for a semester, Ankrum said. The plan is that were going to lay the foundation for a collaborative project that will last for years to come. Thats really the goal is to put in the work so that weve got a great base foundation.
Ankrums trip, he said, looks to research replicating the bodys natural signals to help those with chronic wounds.
Chronic wounds are often seen in individuals with diabetes, as well as military personnel, who are facing increasingly complex injuries from big explosions.
If we can learn how the cells in the body communicate with each other to heal rather than scar, Ankrum said. We can actually mimic those properties, those signals, those communication tactics and employ them as medicines.
Ankrums research with his Irish colleagues will continue to further their research as well.
He said the Royal College of Surgeons combines gene therapies with biomaterial scaffolding, the surface where cells are encouraged to grow.
The scaffolding has gene therapies embedded in the scaffolding and when cells migrate onto the surface of that scaffolding, the cells begin to receive the signals to reproduce.
Ankrums research allows larger-scale research into how to maximize the therapeutic aspect of the structure, Ankrum said.
The ultimate goal of research on regenerative medicine, Ankrum said, is to help reverse the effects of disease and restore the functionality of tissues that have devolved.
With heart disease, for example, tissues become diseased and are failing and no longer function as they once did, Ankrum said. Can we actually turn back the clock by understanding, What are the signals and cues and necessary players to restore true function?
Kristan Worthington, member of the Member Institute for Vision Research and UI assistant professor of biomedical engineering, focuses her research on regenerative medicine within the human retina, the part of the eye responsible for sensing light.
Lots of older people experience vision loss that is, at this point, irreversible, Worthington said. That really impacts someones quality of life in a very big way.
Worthingtons latter research focus mirrors Ankrums focus in Ireland with the biometric scaffolding.
She said regenerative research is important because researchers are still far away from being able to mimic the human bodys ability to stimulate tissue.
For me, its a lifelong pursuit of understanding and being able to modulate the human body to increase quality of life and improve the experience of humans all over the world, Worthington said.
Ankrum said regenerative medicine helps target individual suffering and alleviate it.
Being able to offer [veterans] something that isnt just, Heres pain medication, but something that can actually restore their body to what it once was before they were deployed, that plays into it, Ankrum said.
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The Advanced Pain-Free Treatment as Promoted by QC Kinetix (Murfreesboro) Regenerative Medicine in Murfreesboro, Tennesee – Yahoo Finance
Posted: April 19, 2022 at 2:00 am
MURFREESBORO, TN - (NewMediaWire) - April 15, 2022 - via QC Kinetix -- QC Kinetix (Murfreesboro) has unveiled a series of therapies designed to reduce pain, improve range of motion, and enhance the overall quality of life. Their medical team carefully engineers the biologic therapies to provide lasting relief against joint pain and musculoskeletal injuries. For patients seeking regenerative medicine to calm the throes of chronic pain, the clinic offers zero obligation consultation with a medical provider who will explain the treatment and determine the patient's eligibility.
Chronic pain patients searching for effective regenerative medical solutions in Murfreesboro, TN, will be hard-pressed to choose QC Kinetix (Murfreesboro) as their next stop. The clinic has an experienced medical team ready to give their best to help patients overcome persistent pain and its long-term effects. These natural treatment protocols target knee pain, pain due to sports injuries, elbow pain, and shoulder pain. In addition, patients with sports injuries will readily find experts ready to attend to conditions like golfer's elbow, tennis elbow, and torn rotator cuff. Immediate intervention by QC Kinetix (Murfreesboro) providers will help the patient forgo the uncomfortable knee brace and expensive surgery. It also helps to know that the clinic is top-rated in the Murfreesboro regenerative medicine circles.
The clinic is part of QC Kinetix, a premier regenerative medicine group on a mission to improve patients' overall quality of life by easing their worries about pain and musculoskeletal injuries. Patients are also visiting the QC Kinetix (Murfreesboro) clinic due to QC Kinetix's nationwide network and personalized, concierge-level services touted to be among the very best. The non-invasive treatments also promise long-lasting results, which translates to reduced pain, improved body function and enhanced quality of life. Patients booked at the pain clinic will have their condition carefully assessed before a fitting regenerative therapy plan is created to treat the chronic pain and associated symptoms.
With as many as 80 million Americans suffering from pain, the emergence of regenerative medicine is welcome news for many people. The alternative treatment to surgery has been found effective in treating and managing chronic pain and sports injuries. It works at the cellular level by sparking organic self-repair and restoration of damaged or degenerated body tissues. For patients suffering from pain due to arthritis, regenerative medicine takes away the suffering and replaces it with long-term relief. The state-of-the-art pain control clinic in Murfreesboro, TN, provides treatment with the help of highly experienced providers trusted to administer safe and efficient biologic therapies. Joint pain patients are also invited for a dose of the breakthrough treatment targeting the fingers, toes, ankles, shoulder, wrist, and other joint areas.
QC Kinetix (Murfreesboro) is fully aware of the perils of chronic pain and its net negative impact on depriving patients of the joys of enjoying an improved quality of life. The immediate effects of chronic pain are limited mobility and the inability to perform normal day-to-day activities. To ensure transformative treatment, the providers always target the root cause of the problem before applying the non-invasive treatment protocols to overcome pain and its symptoms once and for all. People who are busy or those seeking to get on with their lives will love the idea that treatment with regenerative medicine carries little to no downtime. Leading the team of providers at the QC Kinetix (Murfreesboro) clinic are Erin Bryan, PA, and Dr. Morgan Keningston, MD, who has been working in the regenerative medicine sphere for five years. She has been a primary-care outpatient physician for eight years and an in-house hospitalist at Williamson Medical Clinic for four years.
Erin Bryan, PA, is an NCCPA-certified Physician Assistant who focuses on delivering quality care to all chronic pain patients. She holds a Bachelor's Degree in Science and a minor in Psychology. The clinic's website has testimonials that show real-life experiences and sentiments of patients treated under the QC Kinetix nationwide network. A YouTube testimonial by a severe knee pain patient shows how he could not run a full half marathon but managed to return to full racing after undergoing treatment. To learn more about their Murfreesboro office, check out their website for first-hand information about the biologic therapies, medical providers, amenities, and more personal accounts of patients who have undergone treatment.
To contact the biologic therapy medical providers, call (615) 249-4024 or visit the clinic that is strategically stationed at 1747 Medical Center Parkway, Suite 110, Murfreesboro, Tennessee, 37129. The cost of treatment using regenerative medicine is revealed during the round of consultation. Their in-house providers will disclose the actual cost after determining the patient's exact treatment, as they strive to provide affordable treatment regimens. A major plus about regenerative medicine is the correspondingly low downtime or recovery time of six to nine months after the safe and effective treatment is administered.
Source: GetFeatured
Company Name: QC Kinetix (Murfreesboro)
Contact Person: Scott Hoots
Phone: (615) 249-4024
Address: 1747 Medical Center Parkway, Suite 110
City: Murfreesboro
State: TN
Postal Code: 37129
Country: US
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The Advanced Pain-Free Treatment as Promoted by QC Kinetix (Murfreesboro) Regenerative Medicine in Murfreesboro, Tennesee - Yahoo Finance
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Hearing Loss Can Be Reversed With New Regenerative Therapy, Say MIT Scientists – IFLScience
Posted: April 19, 2022 at 2:00 am
If you know at least two random people, then chances are you know somebody with somedegree of hearing loss. For many of those people, its just a minor thing an annoying reason to turn the TV volume up. But for others, it candrastically impact quality of life no longer able to make out what loved ones are saying, cut off from the music and social lifethey used to enjoy, and maybe living with endless ringing and buzzing in its place.
Atherapy that could reverse hearing loss would be life-changing for millions and thats what biotechnology company Frequency Therapeutics, a spinout company from MIT, says theyve created. Not a hearing aid, not an implant, but a new drug that can give people their hearing back.
Hearing is such an important sense; it connects people to their community and cultivates a sense of identity, said Jeff Karp, Frequency Therapeutics co-founder and professor of anesthesia at Brigham and Womens Hospital, in a statement. I think the potential to restore hearing will have enormous impact on society.
So how does this potential cure for hearing loss work? Its kind of amazing: the drug stimulates progenitor cells a descendent of stem cells that live in the inner ear to start new making hair cells.
Making your ears more hirsute may not sound like the obvious cure for hearing loss, but it actually makes a lot of sense. We sometimes think of hearing as finishing when the noise hits our eardrum, but thats only half of the story: after that, the vibrations from the sound waves move on to the ossicles the three smallest bones in your body. These tiny bones are really neat: they basically act like a hammer hitting a gong thats next to a loudspeaker. Except teeny.
That loudspeaker, aka the cochlea, is where the hair cells come in. Its a hollow bone in the shape of a spiral the name actually means snail shell filled with fluid. When that fluid is moved by the vibrations from the noise, up to 15,000 hair cells in the cochlea pick it up, and theyre what finally send the signals to the auditory nerve so that we can hear the original noise.
So: no hair cells, no hearing. The problem is, those cells are very fragile they can be damaged by certain illnesses and medications, or even just too many loud noises. And once theyre gone, they dont come back.
Until now, apparently.
Some of these people [in the trials] couldnt hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying, said co-founder and MIT Institute Professor Robert Langer. Its so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me.
Frequency Therapeutics says theyve already given the treatment to more than 200 people, and seen significant improvements in patients hearing in three out of four clinical trials. The therapy is long-lasting hearing has been improved for nearly two years in some cases and it comes in the form of a single injection into the inner ear, making it much simpler and quicker than alternatives like gene therapy.
I wouldn't be surprised if in 10 or 15 years, because of the resources being put into this space and the incredible science being done, we can get to the point where [reversing hearing loss] would be similar to Lasik surgery, where you're in and out in an hour or two and you can completely restore your vision, Karp says. I think we'll see the same thing for hearing loss.
However,perhaps the most tantalizing aspect of this new therapy is its future potential.
Tissues throughout your body contain progenitor cells, so we see a huge range of applications, explained Frequency co-founder and Chief Scientific Officer Chris Loose. We believe this is the future of regenerative medicine.
When we were conceiving of this project, we meant for it to be a platform that could be broadly applicable to multiple tissues, added Karp.
To me its the tip of the iceberg in terms of what can be done by taking small molecules and controlling local biology.
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FDA Grants Direct Biologics Regenerative Medicine Advanced Therapy (RMAT) Designation for the use of ExoFlo in COVID-19 Related ARDS – PR Newswire
Posted: April 19, 2022 at 2:00 am
AUSTIN, Texas, April 12, 2022 /PRNewswire/ -- Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clinical evidence indicating the ability to address an unmet medical need for a serious life-threatening disease or condition. Under the RMAT designation, the FDA provides intensive guidance on drug development and post-market requirements through early and frequent interactions. Additionally, an RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA).
"After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicenter, double blinded, placebo controlled randomized clinical trial, the FDA has recognized ExoFlo as a lifesaving treatment for patients suffering from Acute Respiratory Distress Syndrome (ARDS) due to severe or critical COVID-19," said Mark Adams, Chief Executive Officer. "The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US," he said.
"We are very pleased that the FDA has recognized the lifesaving potential of our platform drug technology ExoFlo. The RMAT has provided a pathway to expedite our drug development to achieve a BLA in the shortest possible time," said Joe Schmidt, President. "I am very proud of our team. Everyone has been working around the clock for years in our mission to save human lives taken by a disease that lacks treatment options, both in the US and abroad. We are grateful for the opportunity to accelerate development of ExoFlo under the RMAT designation as it leads us closer to our goal of bringing our life saving drug to patients who desperately need it."
ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) derived extracellular vesicle (EV) product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC.
Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com.
About Direct BiologicsDirect Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in San Antonio, Texas. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust EV platform technology. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving segment of next generation regenerative biotherapeutics. Direct Biologics has obtained and is pursuing multiple additional clinical indications for ExoFlo through the FDA's investigational new drug (IND) process. For more information visit http://www.directbiologics.com.
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FDA Grants Direct Biologics Regenerative Medicine Advanced Therapy (RMAT) Designation for the use of ExoFlo in COVID-19 Related ARDS - PR Newswire
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What is Australian govt doing to boost stem cell research? – Kalkine Media
Posted: April 19, 2022 at 2:00 am
There are different types of cells designed for a specific job in the human body. To cite a few, white blood cells help in defence, while red blood cells carry oxygen. Stem cells are exceptional cells that possess unique regeneration abilities. They can also create more specialised kinds of cells that can replace the cells lost by the human body either through an injury or in the daily wear and tear process.
Do read: Living Cell (ASX: LCT) surges over 14% on clinical trial for Parkinson's disease
In a broader category, there are generally two types of stem cells
Advances in stem cell research have laid a strong foundation for regenerative medicine. Stem cells have become a frontier of regenerative medicine due to their unlimited self-renewal and differentiation potential.
Regenerative medicine is a division of medicine that works on rebuilding tissues or organs to resume their functions in human beings affected by several injuries or chronic diseases. It has the capability to treat complicated medical conditions that are otherwise impossible by conventional methods.
Image source: German101 | Megapixl.com
Stem cell therapy has proven its potential in treating blood disorders including leukaemia, Hodgkins disease, and non-Hodgkins lymphoma. Stem cells also hold the possibility to cure many other types of complicated medical conditions, boosting hopes for the treatment of incurable diseases.
Also read: Precision medicine: All you need to know
Stem cell research in Australia
Australian scientists have made a considerable contribution to the knowledge about stem cells found in human beings and their potential, particularly in adult stem cells.
Both private and government institutions/firms are involved in stem cell research in the nation. These efforts got a further boost when the National Stem Cell Centre was established in 2002.
Govt pours AU$25 million into stem cell research
According to a report by the Australian Department of Health, the Australian government has provided grants worth AU$25 million for enhancing Australia-led stem cell research. Starting from 2021-22, the fund will be available for over five years through two funding streams.
Stream 1 up to AU$15 million: for developing treatments based on novel stem-cell by large scale multidisciplinary teams.
Stream 2 up to AU$10 million: for large scale multidisciplinary teams. This will be directed towards examination and pre-clinical assessment of novel treatments that deploy human tissues made from stem cells.
Stem Cell Therapies Mission
The Australian government has established the Stem Cell Therapies Mission intending to develop innovative, safe, and efficient treatments to enhance the health conditions of people. It has teamed up with patients and carers and is investing an amount of AU$150 million for the mission.
Also read: How to boost your immunity and maintain distance from pathogens?
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World Liver Day 2022: Expert answers frequently asked questions – The Indian Express
Posted: April 19, 2022 at 2:00 am
Liver is the second largest and one of the most complex organs in the body, yet awareness regarding liver diseases continues to be low. This is why, World Liver Day is observed on April 19 every year to create awareness about diseases related to the liver. Dr Prashant Vilas Bhangui, associate director, Institute of Liver Transplantation and Regenerative Medicine, Medanta Hospital, Gurugram answers some frequently asked questions related to liver diseases.
What is cirrhosis of the liver?
Liver disease initially starts off with fatty liver (where there is an accumulation of excess fat in the liver). This then progresses to fibrosis of the liver which leads to stiffness, and ultimately end-stage liver disease or cirrhosis, the expert added.
Causes
The most common causes of liver disease are viral hepatitis i.e., hepatitis C and hepatitis E, excessive consumption of alcohol, and an unhealthy lifestyle that may cause obesity. A patient who drinks alcohol for prolonged periods of time in substantial quantity ultimately develops cirrhosis. Additionally, people who are overweight, lead an unhealthy lifestyle, have unhealthy diet, lack physical activity, and suffer from co-morbid conditions like diabetes, hypertension, thyroid disorders, and abnormal cholesterol levels are at a risk of developing non-alcoholic fatty liver disease (NAFLD), which progresses to cirrhosis. NAFLD has become a leading cause of cirrhosis of the liver in many countries. Other congenital causes of cirrhosis in children are biliary atresia, metabolic disease of the liver. Some rare causes include autoimmune hepatitis, Wilsons disease, and hemochromatosis.
Symptoms
Initially, a patient may experience constant lethargy, fatigability, swelling of the feet after walking, jaundice, fluid in the abdomen, episodes of bleeding, portal hypertension in the later stage leading to vomiting of blood, blood in stools, internal bleeding. Liver failure also affects other organs like kidney, and even leads to memory loss, and drowsiness.
Diagnosis
If someone has a genetic pre-disposition to cirrhosis and has symptoms of liver disease or is suffering from viral hepatitis for a long period of time, they must get some blood tests, liver function tests, abdominal ultrasound, CT scan, and endoscopy done to understand the stage of cirrhosis they are at.
Stages
Compensated cirrhosis The liver functions get damaged to a great extent; however, the body somehow copes with that liver function, sometimes to an extent of 50-60 per cent.
Decompensated cirrhosis When the liver damage becomes more than about 70-80 per cent. The patients gets symptoms like swelling of the feet, accumulation of fluids in the abdomen, bleeding tendencies, and effects on other organs e.g., on kidneys and brain.
Can cirrhosis be cured?
Once the liver reaches the stage of cirrhosis, the disease becomes irreversible. Fatty liver and early stage of liver fibrosis can be cured through medications along with diet control, understanding causes, and taking proper actions to reverse the condition. Patients at the stage of cirrhosis are highly recommended medical therapies, to support the liver and prevent the progression of the disease. The doctor, based on the CTP (Child-Turcotte-Pugh) score, and other additional scores, determines the treatment procedure i.e., medical treatment or to undergo liver transplantation.
Prevention tips
There are some high-risk individuals who may get exposed to hepatitis B and C like healthcare workers, and patients having blood transfusions, hould be extra vigilant and take extra precautions. The viral markers used to identify a range of Hepatitis B, C, and other viral infections needed to be checked at regular intervals. Experts suggest undergoing an annual check-up including a liver function test, and an ultrasound after the age of 45-50, blood tests are done for early detection, especially for the people who are diabetic, hypertensive, and have thyroid disorders.
People should avoid excessive consumption of alcohol, have a healthy diet, avoid fried and junk food, exercise regularly, avoiding smoking, etc.
Is it possible to cleanse the liver? Is it a myth?
Its more of a myth than reality. There is nothing called cleansing a liver. One can take effective measures including liver-friendly juices, staying hydrated, and eating healthy foods that help in maintaining the healthy liver.
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Pioneering Therapy Gives New Hope to Babies Lacking Thymus – Duke Today
Posted: April 19, 2022 at 2:00 am
Pediatric immunologist Louise Markert, MD, PhD, spent 30 years working to develop a viable treatment to save children born with congenital athymia, a group of rare diseases such as complete DiGeorge Syndrome that are characterized by the lack of a functioning thymus. Without the gland, which trains the bodys T-cells to fight pathogens, minor infections can be fatal; untreated children with congenital athymia typically die by the age of three.
On October 8, 2021, Markert's long journey came to fruition whenthe U.S. Food and Drug Administration (FDA) approved a regenerative medicine based on her pioneering work as the only therapy for congenital athymia.The therapy, licensed to Ezyvant Therapeutics, uses cultured thymus tissue to generate a functioning immune system in children without a thymus. In clinical trials, children who received the treatment showed dramatically improved survival rates. FDA approval makes the new therapy available beyond clinical study.
"This really has been the culmination of my career at Duke. It's just overwhelming how happy one can be, helping these children," Markert said.
There's more to come. The foundation set by herresearch is expanding transplant opportunities, as seen by the recent combinationheart/thymus transplant in a baby at Duke that represents a milestone in heart transplantation.
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Oakhill Veterinary Practice in Windermere employs groundbreaking technology | The Westmorland Gazette – The Westmorland Gazette
Posted: April 19, 2022 at 2:00 am
STEM cell technology, rivalling that used on humans, is being employed in the treatment of animals by a cutting-edge veterinary practice.
Oakhill Veterinary Practice is attracting interest from pet owners and professionals across Cumbria with its innovative approach to maximising animal welfare.
The practice, based in Windermere, has just taken delivery of its latest high-tech equipment including a Stance Analyser and Regenerative Medicine kit, allowing the practice to now offer platelet-rich plasma (PRP) and stem cell therapy to be used in a variety of conditions.
Regenerative Medicine is an established treatment option in the equine world but is gaining more traction with canine companions.
Principally the anti-inflammatory, regenerative and healing capacity of the animals own cells are harnessed and then employed to treat the dogs orthopaedic or neurological condition.
The equipment can separate stem cells from harvested bone marrow or can be used to concentrate platelets which are then injected into parts of the animals body requiring treatment, such as arthritic joints, tendon and ligament injuries, muscle sprains, acute and chronic soft tissue injuries and certain spinal conditions.
Because the cells come from the animals own body there is minimal risk of rejection or side-effects, according to the practice.
And by using regeneration to heal the tissue, the use of drug therapy can be minimised.
Stem cells are immature cells that dont know what their job as an adult cell will be, said practice partner Alex Kirby.
As they mature, their destiny is dictated by neighbouring tissues in the body, whether that is cartilage, skin, nerve or tendon, essentially allowing those damaged tissues to heal, repair and regrow.
The practice is one of only a handful in the country using these techniques which have been pioneered and refined for use in dogs in America.
The equipment is also used to prepare platelet-rich plasma, which is hugely anti-inflammatory and again stimulates healing. Depending on the condition of an arthritic joint, the beneficial effects can last up to 24 months and means some dogs can live life off most, if not all, medication.
The practice has also invested in a specialised stance analyser which measures the distribution of weight carried through each leg, expressed as a percentage of bodyweight. This allows the vets to pinpoint problem areas at an earlier stage than waiting for the dog to show overt signs of pain.
Vet Marcelle Cassar, clinical director of the Animal Rehabilitation Centre (ARC), said: There are many potential yet subtle orthopaedic issues with dogs; this equipment will help to highlight them for us.
Additionally, it will be instrumental in tracking the progress of the dog as it goes through its rehabilitation programme in the Animal Rehabilitation Centre, for example after orthopaedic surgery.
The idea behind investing in this piece of equipment is to help us measure how well we are progressing with our treatment in a quantifiable way, she said. It gives us hard data and will be used alongside other pain-scoring measures, such as questionnaires, which are more subjective. Our aim is always to improve a dogs comfort and mobility and this will help us to do that.
The new equipment is the latest phase of development in a practice, run by Alex and partner Matthew Stables, that offers end-to-end care, from initial consultation and diagnosis, to surgery, regenerative medicine and rehabilitation including hydrotherapy, physiotherapy, laser treatment, acupuncture and massage therapy.
Oakhill Vet Group also shares its expertise with other vet practices taking referral work in soft-tissue and orthopaedic surgery, rehabilitation and behaviour cases.
Alex, who also sits on the Lakeland Veterinary Association Committee, said: We are trying to get as close to perfect as possible with the management and treatment of a host of degenerative conditions in our pets. This technology is the next bit of the jigsaw and now that it is available to us we can use it to learn what we need to do together to maximise animal care.
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European Wellness Signs MOU in Dubai Expo 2020 to Strengthen Medical Tourism into Malaysia and Develop Advanced Biological Regenerative Medicine in…
Posted: April 19, 2022 at 2:00 am
DUBAI, UAE, April 13, 2022 /PRNewswire/ -- European Wellness Biomedical Group (EW Group), through its Malaysian subsidiary European Wellness Academie, and Dubai- based healthcare distribution and technology group, AK International LLC, have signed a Memorandum of Understanding (MOU) on 30th March 2022 that aims to strengthen the medical tourism linkages and access to Biological Regenerative Medicine services in the United Arab Emirates and Malaysia.
EW Group and AK International's MOU signing was the first to be finalised during the signing ceremony, under the witness of Malaysias Prime Minister YAB Datuk Seri Ismail Sabri Yaakob, Science, Technology and Innovation Minister Datuk Seri Dr Adham Baba, International Trade and Industry Minister Datuk Seri Mohamed Azmin Ali, Rural Development Minister Datuk Seri Mahdzir Khalid, and Deputy Minister of Works Datuk Arthur Joseph Kurup.
Logo (PRNewsfoto/European Wellness Biomedical Group)
The signing marks a significant milestone in EW Group's effort to scale up the global adoption of rapidly emerging German and Swiss medical paradigms and cell-based bio- therapeutics for the integrative management of chronic degenerative conditions and untreatable rare diseases.
Witnessed by YAB Dato' Sri Ismail Sabri Yaakob, Prime Minister of Malaysia, the MOU were signed by Prof. Dato' Sri Dr. Mike Chan, European Wellness Group Chairman and Dr. Aasif Ali Siddiqui, Managing Director of AK International.
The strategic collaborations seeks to setup two Centers of Excellence, one specializing in the rehabilitation, education and holistic management of pediatric neurodegenerative and neurodevelopmental disorders such as Autism Spectrum Disorder, Cerebral Palsy, Down Syndrome and Global Developmental Delay, and another specializing in the management of untreatable and rare diseases such as CHARGE Syndrome, Multiple Sclerosis, Rheumatoid Arthritis, Parkinson's Disease etc.
EW Group Chairman Prof. Dato' Sri Dr. Mike said, "We are confident that our 30 years of cell therapeutic research efforts across Europe, along with a passionate team of international top clinicians trained in Germany and Switzerland, can support the delivery of an impactful and personalized disease management model to the communities in UAE."
"Moreover, these Centers are also vital frontlines to assist local patients seeking for biological regenerative medicine solutions at our overseas destinations to have easy access to an efficient and collaborative case referral network from initial inquiry, to preliminary medical investigation, to assisted medical travel, and finally to follow-up care," he said.
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Since 2017, EW Group has embraced the growth strategies of licensing its proprietary clinical systems, protocols and patented bio-therapeutics to new joint-ventures, rendering the rapid expansion of its healthcare facility division from 2 flagship centers in Switzerland and Malaysia in 2016 to a global network of 26 medical and healthcare centers today.
In addition, EW Group and AK International are looking into the development of a technology driven 'Digital Wellness Service Corridor', in the form of an AI-driven application pioneered by AK International's subsidiary Artelir Inc. that shall seamlessly connect patients from United Arab Emirates with healthcare service providers in Malaysia.
AK International Director Dr. Aasif Ali Siddiqui commented, "One of the goals of this MOU is to increase medical and wellness tourism in Malaysia while also offering Emiratis modern medical treatments in other countries. Patients with incurable uncommon diseases or neurodegenerative disorders, for example, may have restricted access to innovative treatment alternatives, such as cell-based or biomolecular therapies, in their local area."
The partnership is also set to explore potential investments into Iskandar Malaysia Development Area in Johor for the development of a world-leading Halal Hub for Biotechnology and Regenerative Medicine. The unique development project valued at USD 60million shall comprise a 100-bed integrative medicine hospital modelled after EW Group's medical facility in Germany, Muslim-centered aged care retirement villas and assisted living apartments, and a GMP-certified halal biologics and botanical drug manufacturing facility.
"Our Group is ever ready to extend more than 50 of our proprietary plant-based pharmaceuticals with German approval for immediate production in Malaysia and export to meet the growing global demand for natural medicine," Dato' Sri Mike said.
"This project will bring a tremendous opportunity to strengthen Malaysia's vision and current positioning as the world's Muslim hub for innovative biotechnology developments, especially on herbal medicine research and botanical drug manufacturing."
EW Group is a recipient of multiple awards for its pioneering biotech innovations in Paris, Geneva, London and Kuwait, and currently holds multiple international patents on innovative biotechnological processes and formulation for its Cell and Gene Therapy Products (CGTP) and Biologics, including precursor (progenitor) stem cells, biological peptides and anti-idiotypic antiobodies for immunology and botanical formulation for parenteral nutrition.
About European Wellness Biomedical Group
European Wellness Biomedical Group (EW Group) is an award-winning European group founded by Prof. Dato' Sri Dr. Mike Chan and Prof. Dato' Sri Dr. Michelle Wong in early '90s in Switzerland through the culmination of early cell therapeutic research efforts spanning across Switzerland, Germany, Russia and Austria since the mid '80s.
Today, EW Group is most renowned for its pioneering developments in organ-specific precursor (progenitor) stem cell therapeutics, biological and synthetic peptides, biological regenerative medicine, immunotherapies, nutraceuticals and cosmeceuticals. EW Group's multinational business divisions include research and development; bio-manufacturing; biomedical academies for continuing education and training (including 20+ published medical books, 50+ scientific journals and 20+ international accreditations); medical facilities and anti-ageing centres; and nutraceutical product distribution to licensed practitioners and consumers across 80 countries worldwide.
EW Group also owns and operates a growing network of internationally accredited Hospital and Medical Centers specialising in Regenerative Biomedicine and luxury Wellness Centres globally. Currently, the Group is headquartered in Germany and Malaysia (Asia Pacific) with its own research and biopharmaceutical manufacturing facilities vested in Germany, Switzerland, United States, Czech Republic, and United Kingdom.
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SOURCE European Wellness Biomedical Group
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Actinium Pharmaceuticals, Inc. and Immedica Announce Commercialization Agreement for Iomab-B (131I apamistamab) in Europe, the Middle East and North…
Posted: April 19, 2022 at 1:59 am
-Potential for up to $452 million in milestone payments with royalties in the mid-twenty percent range
-Actinium receives $35 million upfront payment
-Immedica obtains exclusive rights to Iomab-B in Europe, the Middle East and North Africa
NEW YORK and STOCKHOLM, April 12, 2022 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs, and Immedica Pharma AB ("Immedica") today announced entering a license and supply agreement for Iomab-B, an Antibody Radiation Conjugate comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131 that is being developed for targeted conditioning to facilitate bone marrow transplant (BMT) and other cell and gene therapies. A pivotal Phase 3 trial, Study of Iomab-B versus Conventional Care in Elderly, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA), of Iomab-B completed patient enrollment in the third quarter of 2021 with topline data expected in the third quarter of 2022. BMT is the only potentially curative treatment option for patients with active, relapsed or refractory acute myeloid leukemia (AML).
Sandesh Seth, Actinium's Chairman and CEO, said, "Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant."
"We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica.
Under the terms of the agreement, Actinium will receive an upfront payment of $35 million and will be eligible to receive an additional $417 million in regulatory and commercial milestones as well as royalties in the mid-twenty percent range on net sales. Immedica receives commercialization rights in Europe and MENA countries. Actinium retains all rights related to Iomab-B in the United States and the rest of the world, and will be responsible for certain clinical and regulatory activities and the manufacturing of Iomab-B.
Shadow Lake Group (SLG) served as the advisor to Immedica.
About Iomab-BIomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient's cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient's cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.
Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B also has patent terms extending to at least 2036/2037 in the US and EU. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.
About the SIERRA Phase 3 TrialThe SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician's choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician's choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.
About Actinium Pharmaceuticals, Inc.Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs not addressed by traditional cancer therapies. Actinium's current clinical pipeline is led by ARCs or Antibody Radiation-Conjugates that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. Actinium's targeted conditioning ARCs seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning that complete patient enrollment in the third quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. Iomab-ACT, low dose I-131 apamistamab is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center. In addition, we are leaders in the field of Actinium-225 alpha therapies. Actimab-A, our clinical stage CD33 targeting ARC alpha therapy has been studied in nearly 150 patients including our ongoing combination trials with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 170 patents and patent applications, know-how, collective research and expertise in the field are leveraged to design and study novel targeted radiotherapies and combinations to strategically bolster our pipeline. Our AWE technology platform is currently being utilized in collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc.to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRP inhibitor. Website: https://www.actiniumpharma.com/
About Immedica ABImmedica is a fast-growing private niche pharma group with its headquarter in Stockholm, Sweden, and commercial coverage across Europe and the Middle East. Immedica has significant know-how and experience in commercialization of specialty care products across Europe and the Middle East, and the company's management team has an outstanding track record of operating niche pharma products internationally. Immedica has capabilities to provide optimal access of specialty care medicines to patients with significant medical needs, including key areas such as regulatory affairs, pharmacovigilance, medical affairs, pricing & reimbursement, quality assurance and product distribution.
More information is available at http://www.immedica.com
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Actinium Contacts
Investors:Hans VitzthumLifeSci Advisors, LLC[emailprotected](617) 430-7578
Immedica Contacts
Chief Executive OfficerAnders EdvellImmedica Pharma AB[emailprotected]+46 (0)70 544 6126
SOURCE Actinium Pharmaceuticals, Inc.
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Actinium Pharmaceuticals, Inc. and Immedica Announce Commercialization Agreement for Iomab-B (131I apamistamab) in Europe, the Middle East and North...
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