OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial for Hypertrophic Scars

SUWON, Republic of Korea, Oct. 30, 2020 (GLOBE NEWSWIRE) -- OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to evaluate the efficacy of OLX10010 as an adjunct therapy to reduce the recurrence of hypertrophic scars after scar revision surgery.

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OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial for Hypertrophic Scars

Medexus Announces Engagement of Westmount Capital and Equity Incentive Grants to Insiders

TORONTO and CHICAGO and MONTREAL, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced today that it has entered into a consulting agreement (the “Consulting Agreement”) with Westmount Capital (“Westmount”) to provide European investor relations services to the Company in compliance with the policies and guidelines of the TSX Venture Exchange and applicable legislation. Under the terms of the Consulting Agreement, Westmount will receive C$5,000 per month for an initial trial period of 3 months, commencing on November 1, 2020, following which a possible extension will be reviewed by the Company. The services contemplated under the Consulting Agreement include introducing the Company to various institutional investors, fund managers, family offices and other potential investors throughout Europe.

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Medexus Announces Engagement of Westmount Capital and Equity Incentive Grants to Insiders

CymaBay Therapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020

NEWARK, Calif., Oct. 30, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that it will host a conference call and live audio webcast on Thursday, November 5, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the third quarter and nine months ended September 30, 2020 and to provide a business update.

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CymaBay Therapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020

Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger Largest studies in POMC and LEPR deficiency obesities demonstrate that treatment with setmelanotide reduced body weight and hunger

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Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trials of Setmelanotide in The Lancet Diabetes & Endocrinology

Stem Cell Therapy for Autism: Effects & Costs in 2020

As a parent of an autistic child, you want to see your child live to their fullest potential. When a clinic offers stem cell therapy for autism, which seems like a miracle cure, you may want to immediately pursue it. You want to try anything that could help your child function better in the world.

Many clinics offer stem cell therapies to treat a range of conditions, including autism. While there is some important new medical research being conducted on how well stem cells work in mitigating symptoms of autism, none of these treatments have received FDA approval.

In 2020, these stem cell therapy treatments are not considered safe for children with autism.

Stem cell therapy is a new field in medicine that offers huge potential to treat conditions that have few other options.

However, there are questionable operations claiming to use stem cells to rejuvenate, improve, or even cure conditions that have no immediate cure. It can be difficult to know the difference between what is advertised as a legitimate medical treatment and what might actually be harmful for someone with a long-term condition like autism.

Stem cells are sometimes referred to as the bodys master cells because they are like a blank slate for creating new cells. Bones, organs, blood, and brain cells all start as stem cells.

In some instances, these cells might regenerate, restore, or even replace these tissues. This means that, when used in some medical treatments, stem cells have the potential to fix many underlying issues. The United States Food and Drug Administration (FDA) regulates stem cell products in the U.S.

The FDA has approved limited use of stem cells in treatments for some types of cancer or disorders of blood and bone marrow. As more stem cell treatments are tested in clinical trials in tightly controlled human studies, more conditions may appear to have prescribed stem cell treatments associated with them. While these clinical trials are very important and can help study participants, few of these clinical trials lead to cures or even therapies to manage the condition.

Before pursuing a clinic offering stem cell therapy, check whether the practitioners have received FDA approval for the treatment.

Autism is one of the conditions that could potentially one day benefit from stem cell treatments. This developmental disorder mainly impacts behavior, socializing, communication, and cognition.

Some anecdotal evidence exists that clinics offering unapproved stem cell treatments benefit people with autism; however, there is very little evidence through medical studies that this is possible. Currently, the best treatment for autism is behavior therapy like applied behavior analysis (ABA).

There are several clinics offering stem cell treatments for a range of conditions, including autism, joint pain from any source, and multiple sclerosis. The cells used in treatment tend to come from fat cells donated or sold after liposuction treatment.

Typically, these cells are autologous , meaning they are extracted from the patient to create the stem cell therapy and then infused back into the patient. Some clinics use bone marrow or umbilical cord tissues, which come from different donors who are not genetically related to the person receiving treatment.

While clinics report happy testimonials from people who undergo these therapies, it is important to note that many of the reported benefits are associated with conditions that have symptoms that fluctuate over time. For example, arthritis symptoms may come and go, with flareups of pain and inflammation persisting for several weeks or months and then going away as the condition temporarily goes into remission.

Children with autism tend to be diagnosed at a young age, often around 2 or 3 years old . It is well established that autistic children should receive evidence-based treatment like ABA therapy to reduce later problems with communication, cognition, and socializing. The efficacy of many new treatments for autism is unproven.

It can be difficult for medical studies into any therapy, including a new treatment like stem cell injections, to definitively know if improvements in symptoms are associated with the therapy or with natural developmental changes that can lead to improvements in autism symptoms as the child gets older. More research is needed to solidify conclusions, and currently, the research into stem cell therapy for autism is lacking.

There are concerns that companies may be preying on autistic parents , offering the hope of a cure for autism or a dramatic improvement in symptoms that just hasnt been proven. Some stem cell therapy companies charge tens of thousands of dollars for this treatment. Regulators warn that the treatments may be illegal, unsafe, and potentially harmful.

While parents should be wary of commercial stem cell therapy offerings, studies into the practice are ongoing.

As of a 2018 meta-survey , there were several clinical trials using stem cells to manage autism symptoms.

Overall Improvement With Potential for Adverse Effects

For example, one study followed 32 school-aged participants whose ages averaged about 10.5 years old. The group received bone-marrow-derived mononuclear cell (BMMNC) transplantation, which uses stem cells from blood. The protocol involved the intrathecal cellular therapy as well as other important therapies for autism, including occupational, sensory integration, psychological, dietary, and speech therapy.

During the course of the study, three participants developed seizures, and a small percentage of the group developed mild increases in hyperactivity as a result of the stem cell treatment. However, as a group, there were noted improvements in social relationships and reciprocity like smiling and eye contact; thinking, attention, and cognition; and speech and language patterns and usage. There was also a decrease in inappropriate emotional responses, self-stimulating behaviors, excitement or agitation for no clear reason, and exaggerated emotional responses.

While there were some adverse side effects, many improvements were also seen in the small group.

More Benefits for Nonverbal Children With Higher IQs

Another clinical trial examined a group of diagnosed autistic children between the ages of 2 and 7 to see if autologous umbilical cord blood (AUCB) transplantation could improve some autism symptoms. Subjects were randomly divided into two groups, with one receiving the stem cell transplant and the other receiving saline injections.

At a six-month follow-up, the group who received infusions had better socialization, communication, and adaptive behavior scores compared to the control group. The improvement was sustained at a one-year follow-up.

Unlike some other studies, nonverbal children with higher IQs seemed to benefit the most from this type of stem cell infusion. The researchers stated that the improvements could also be associated with natural development as the children entered preschool.

The Necessity of FDA Approval

There have been three other major stem cell studies involving children with autism, but they have all had a wide variance in the treatments used, study participants, how outcomes were measured, and even how the studies were designed.

More importantly, clinical trials do not prove that stem cell therapies work. Pursuing any that do not have FDA approval could cause harm to your child. Problems With Getting Stem Cell Therapy for Autism in 2020

While you want to do everything possible to help your child, there are some serious risks with attempting unapproved treatments like stem cell therapy. These risks remain even if the clinic is managed by medical personnel, has a good reputation, or appears clean.

If you participate in an unproven treatment that is not FDA-approved, like stem cell therapy, you could put your child at risk for:

Infections.

Tumors.

Inflammatory conditions due to unfamiliar cells.

Skin irritation at injection sites.

Damage to the central nervous system when using lumbar punctures.

Because these clinics are not real medical clinics , they dont have licenses or oversight. You will not receive any health insurance coverage for these treatments as they are considered experimental.

These clinics are essentially boutique operations. They often charge a lot of money while falsely raising your hopes about the outcome. Parents suffer through grief and frustration when the treatment doesnt work, and they are left with a major financial setback.

The best way to help your child when they receive an autism diagnosis is to pursue evidence-based treatments that are recommended by your pediatrician and other specialists.

Treatment will most likely involve behavior therapy like ABA. This therapy has been shown over decades of practice and numerous medical studies to help people with autism manage behaviors associated with the condition. Speech therapy and occupational therapy are also commonly part of an autism treatment plan, depending on the severity of the disorder and the childs specific needs.

Complementary treatments like art therapy or music therapy can round out a treatment plan. These creative therapies help to improve behaviors, socializing, communication, and motor skills.

In 2020, there is no known cure for autism . While it can be tempting to pursue any therapy that is promising a miracle treatment, be aware that these claims are not based in science. Unfortunately, parents who pursue these false treatments are wasting money and experiencing immense stress.

There are ongoing clinical trials into the efficacy of stem cell therapy for autism, so well learn more about this possibility in the coming years. Until then, stick with therapies your treatment team recommends. This will ensure the safety and progress of your child.

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Stem Cell Therapy for Autism: Effects & Costs in 2020

aHSCT Gets a Boost in US With NMSS Recommendations – Multiple Sclerosis News Today

Is the United States a step closer to approving a form of stem cell transplantation as a treatment for multiple sclerosis? I believe it may be.

Thats because the National Multiple Sclerosis Society (NMSS) has slightly changed its view of autologous hematopoietic stem cell transplantation, or aHSCT.

aHSCT involves removing a patients own stem cells from the blood or bone marrow, using chemotherapy to kill off most of the immune system, and then injecting the stem cells back into the patient. Those stem cells regenerate the immune system, hopefully without any of the rogue immune cells that attack the nervous system and create MS symptoms.

In the past, the National MS Society has failed to make recommendations about how any form of stem cell treatment should be used, at least as far as my research can determine. Now, in an article in JAMA Neurology, a group of neurologists, including members of the NMSS National Medical Advisory Committee, are outlining parts of a stem cell protocol.

The NMSS is now being specific about who might be a candidate for aHSCT:

The National Multiple Sclerosis Society believes that AHSCT may be a useful treatment option for people with relapsing multiple sclerosis who demonstrate substantial breakthrough disease activity (ie, new inflammatory central nervous system lesions and/or clinical relapses) despite treatment with high-efficacy disease-modifying therapy or have contraindications to high-efficacy disease-modifying therapies.

That language seems more aggressive than what the NMSSwrote about an Italian study published earlier this year. In that commentary, the society suggested the procedure might be appropriate for people with secondary progressive MS, and it suggested further study with a larger group:

These results suggest that HSCT might be appropriate in a subgroup of people with SPMS that have significant inflammatory activity as measured by MRI. Further study in larger numbers are needed to understand who among those with secondary progressive MS might benefit from HSCT.

The new guidelines clearly outline which people with relapsing-remitting MS might benefit. They are younger than 50 and have lived with an MS diagnosis for less than 10 years.

The authors recommend that stem cell transplantation be performed in medical centers with substantial experience and expertise. A follow-up regime is proposed, along with the creation of a single database to track people who undergo the procedure. But the article cautions that more research is needed to establish best practices for handling the stem cells and other technical processes.

Some hospitals and clinics in Russia, Mexico, and other locations offer aHSCT to MS patients at a cost of about $50,000. aHSCT also is provided to some MS patients through the U.Ks National Health Service. A list of aHSCT facilities worldwide is available at http://www.hsctstopsms.com.

The authors of the JAMA Neurology article suggest a clinical trial may be the place for someone who wants their MS treated with a stem cell transplant right now. A well-known trial by Dr. Richard Burt shut down about a year ago. However, a trial called BEAT-MS has been enrolling patients at several locations in the U.S. You can find information about other studies at clinicaltrials.gov.

The authors note that joining a trial would assure the patient of quality care with an acceptable protocol and provide the personal satisfaction of knowing they are contributing to answering a very important question for people with MS.

That sounds like a pretty good suggestion to me since the U.S. likely has a long way to go before aHSCT for MS becomes common here, even with the NMSS backing. But its encouraging that finally it is gaining some traction.

Youre invited to follow my personal blog at http://www.themswire.com.

***

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Diagnosed with MS at age 32 in 1980, Ed has written the MS Wire column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. Hes won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. Hes the author of Were Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis. Ed and his wife split time between the Washington, D.C. suburbs and Floridas Gulf Coast.

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aHSCT Gets a Boost in US With NMSS Recommendations - Multiple Sclerosis News Today

Optimal Health: Cutting Edge Restorative Treatments Cityview – Knoxville City View

For 36 years the professionals at Optimal Health have served the people of the greater Knoxville area. Licensed chiropractor and founder J. Scott Brown and his family established their first clinic in West Knoxville. As his family grew so did Dr. Browns vision. He began to bring on medical doctors, nurse practitioners, and physical rehabilitation professionals, all trained in the most cutting-edge treatments for acute and chronic pain. His practice evolved to become one of the largest integrated medical groups in Knoxville, with four locations in the greater Knoxville area, the newest of which is in Turkey Creek. Integrated Medical Optimal Health in Turkey Creek will offer the same integrated medical treatments as the other three locations, but they have just launched a new, cutting-edge pain management treatment called RP Softwave. It uses gentle radial pulse technology to penetrate deep into the soft tissue area of any joint in the body to relieve pain. Patients typically feel relief after the first treatment.

Dr. Brown has a heart for people and wants to see them live their best lives. Hes wants to help them to fully rehabilitate and regenerate naturally. Having been at the forefront of cutting-edge medical advancements and technologies, in early 2019 the family branched out again and opened Optimal Health Regenerative Aesthetics Medical, which is Knoxvilles only full-service regenerative medicine facility.

He identified ways to help people achieve optimal health through regenerative therapies rather than using traditional methods such as surgery or pain medications. The new practice, Optimal Health Regenerative Aesthetics Medical, in Turkey Creek, uses proven, safe regenerative therapies to restore and repair tissue in the joints as well as to treat other inherited or acquired, acute or chronic conditions. They offer a full range of regenerative services. One of their more sought-after services is stem cell therapy for joint repair. Stem cell therapy uses growth factors to repair and rebuild damaged tissue.

They also offer treatments for vaginal rejuvenation and erectile dysfunction. Many of their female patients have overcome urinary incontinence with the revolutionary O-Shot. As one of only four providers of the innovative GAINSwave erectile dysfunction treatment, Optimal Health has provided results for hundreds of men using this treatment combined with regenerative therapies such as the P-shot for truly life-changing results.

Their medical staff also oversees and provides nutritional counseling through a variety of medical weight loss options. They provide regenerative facial aesthetics using the latest innovative practices and equipment such as combining PRP with micro-needling, also known as the Vampire Facial. The clinics licensed aesthetician begins each consultation with a comprehensive facial scan using the PEAR facial scanner. Optimal Health is the only aesthetics clinic in East Tennessee with this technology. The scan can pinpoint with great accuracy the age of your skin as well as help to identify areas that may need immediate protection or treatment. Optimal Health is also known as the Tennessee Center for Excellence as they are the only provider in the state of Tennessee with exclusive rights for the minimally-invasive hair restoration treatment, SmartGraft. Developed by physicians, medical scientists and engineers, SmartGraft allows Optimal Health to perform hair restoration procedures safely and rapidly while delivering natural, permanent results.

The doctors and other providers at Optimal Health have decades of practice in the fields of physical and regenerative medicine. With a well-rounded knowledge of the human body, medically and holistically, the staff at Optimal Health provide the most effective, non-invasive wellness, aesthetics, and pain management services available. At Optimal Health they love to say, You only live once, so take care of yourself! #YOLOTCOY

11668 Parkside Drive

865.288.4200

Knoxvilleoptimalhealth.com

11660 Parkside Drive

865.288.4300

2905 Tazewell Pike

8906 Kingston Pike

217 N. North Calderwood Street, Alcoa

865-690-1455

Integratedmedicaltn.com

Matt cut his writing teeth at NY ad agencies selling colas, credit cards, frozen confections and more for companies like Sealtest, Coke, and American Express. Over the course of the past few decades, he has made the switch from selling to storytelling, and can spend his days doing the two things he loves most; learning and writing. When not writing, Matt keeps pretty busy simply trying to keep up with his four daughters, three cats, two dogs, and a guinea pig named "Rosie." Luckily, his wife is there to help keep him sane.

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Optimal Health: Cutting Edge Restorative Treatments Cityview - Knoxville City View

How pain changes your brain – News – The University of Sydney

Professor Paul Glare at the Pain Management Research Institute.

Opioids are good for acute pain. With chronic pain they only work short to medium term, he says. But after about six months, you become tolerant and have to take bigger doses. Then theres the growing risk of accidental overdose, even accidental death.

For many people though, opioids seem like the only way to numb the pain that constantly attacks them. But do they in fact, numb the pain?

Most people who come off the long term use of opioids realise that the drugs werent doing that much, says Glare. Theyd already stopped working, so the pain without them is often no worse. In fact, the drugs were just messing with their heads. Still its a huge psychological step to let the drugs go.

Gently spoken and with a great sense of compassion for the people he works to help, Glare started his career in palliative care which took him into the area of cancer pain, then pain more generally. Because its difficult to tell people battling chronic pain that there is no satisfactory pharmaceutical answer at this time, the PMRI has a large and active pain education unit.

The Unit offers a Masters of Medicine Pain Management that is also conferred as a Masters of Science for non-medical graduates. It also runs cognitive behavioural therapy classes teaching strategies for rising above the pain.

The classes are challenging, says Glare. But many people who learn the self-management techniques can reduce or even stop their opioid use. Its about them not being afraid of their pain anymore.

Its the nature of chronic pain that the injury its warning you about, sometimes very loudly, isnt actually there. This can be seen in a persons posture as they sit and walk in a way that protects that non-injury. By gently confronting the pain, the person can eventually reclaim their normal posture and walk more confidently. Through that, they feel stronger within themselves and more in control of their pain.

The PMRI is now looking at digital support resources for people dealing with pain, Were developing an SMS based text messaging service and a more sophisticated chat-bot tool, to help people get over the hump of opioid tapering, says Glare. Its new in the pain world.

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How pain changes your brain - News - The University of Sydney

Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market – BioSpace

Global Cell Banking Outsourcing Market: Overview

The global cell banking outsourcing market is likely to be driven by the rising demand for biopharmaceutical production targeting novel active sites, stem cell therapy, and gene therapy. A cell bank is a facility storing cells extracted from various organ tissue and body fluids so as to cater to the needs of the future. The cell banks make storage of cells with an elaborate characterization of the entire cell line as it reduces the possibilities of cross contamination. These benefits are estimated to fuel expansion of the global cell banking outsourcing market over the timeframe of assessment, from 2020 to 2030.

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Cell banking outsourcing industries engage testing, characterization, storage, and collection of tissues, cell lines, and the cells. These activities are done to assist in the production of biopharmaceuticals and in the research and development activities so as to ensure minimum adverse effects and high effectiveness. The procedure of the cell storage involves first proliferation of cells, which then multiplies in a huge number of identical cells and is then put inside cryovials safety for use in future. Cells are primarily utilized in the production of regenerative medicine. A surge in the number of cell banks together with the high demand for stem cell therapies is likely to work in favor of the global cell banking outsourcing market over the tenure of analysis, from 2020 to2030.

The global cell banking outsourcing market has been segmented on the basis of four important parameters, which are bank type, phase, cell type, and region.

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Global Cell Banking Outsourcing Market: Notable Developments

The global cell banking outsourcing market is considered a fairly competitive market and is marked with the presence of many leading market players. The companies in this market are forging mergers, partnerships, and collaborations so as to gain larger revenue and market share. The following development is expected to play an important role in the market:

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Global Cell Banking Outsourcing Market: Key Trends

The global cell banking outsourcing market is characterized by the presence of the following restraints, drivers, and opportunities.

High Demand for Stem Cell Therapies to Trigger Growth of the Market

The rising number of stem cell therapies across the globe primarily influences the global cell banking outsourcing market. According to a survey conducted by World Network for Blood and Marrow Transplantation (WBMN), nearly 1 million hematopoietic stem cell transplantation processes were conducted in between 2006 to 2014. These figure comprised removal of stem cells procedures from peripheral blood or bone marrow, proliferating, and then finally storing them cell banks for future use by patients. Stem cell therapies are able to multiple disease, such as amyotrophic lateral sclerosis, type 1 diabetes, cancer, Alzheimer's disease, Parkinson's disease, and so on. Ability to cure such a wide variety of diseases is expected to propel growth of the global cell banking outsourcing market in the years to come.

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Global Cell Banking Outsourcing Market: Geographical Analysis

North America is expected to dominate the global cell banking outsourcing market throughout the timeframe of analysis, from 2020 to 2030. Such high growth of the North America market is ascribed to the increased production of antibiotics, therapeutics protein, and vaccines. In addition, presence of several biopharmaceutical companies in the region is anticipated to foster growth of the cell banking outsourcing market in North America in the near future.

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Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market - BioSpace