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Bubba Wallace isn't interested in making headlines for what he says or does off the track. They're the real deal. From Good Housekeeping. The results indicate that a single injection of rexlemestrocel-L may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred.
Patients were randomized to receive a single intra-discal injection of either rexlemestrocel-L using a unit dose of 6 million allogeneic mesenchymal precursor cells MPCs , with or without hyaluronic acid HA carrier, or saline control, and stratified for opioid use at baseline to ensure all three treatment arms were equally represented in this pre-defined population. The study was conducted across 48 sites, predominantly in the United States.
Key analyses were performed on the total study population and on the pre-specified subsets of opioid users at baseline and patients with CLBP duration shorter or longer than the median for the whole study population.
Regulatory approval of pharmaceutical agents, such as opioids, in the treatment of chronic pain syndromes generally requires reduction in pain as the primary outcome. Mesoblast Chief Medical Officer Dr. On the basis of the Phase 3 trial results, we intend to meet with the FDA and discuss potential pathways towards approval for rexlemestrocel-L, including as an opioid sparing treatment in patients with DDD.
Back pain causes more disability than any other condition9 and inflicts substantial direct and indirect costs on the healthcare system9, including excessive use of opioids in this patient population. There are few treatment options for patients with CLBP who fail conservative therapy, including opioids, spinal injections and surgery e. About Mesoblast Mesoblast is a world leader in developing allogeneic off-the-shelf cellular medicines for the treatment of severe and life-threatening inflammatory conditions.
The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least in all major markets. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome.
For more information, please see www. Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled month study of safety and efficacy. The Spine Jnl. Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain: a systematic review and meta-analysis.
Epidemiology of regular prescribed opioid use: results from a national, population-based survey. Hyaluronic acid coatings as a simple and efficient approach to improve MSC homing toward the site of inflammation. Pain Med. Pathophysiology, diagnosis, and treatment of discogenic low back pain. World J Orthop. PloS One. Comparison of lumbar total disc replacement with surgical spinal fusion for the treatment of single-level degenerative disc disease: a meta-analysis of 5-year outcomes from randomized controlled trials.
Glob Spine J. Opioids compared to placebo or other treatments for chronic low-back pain. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med ; 4 —86Annual surveillance report of drug-related risks and outcomes United States, Centers for Disease Control and Prevention Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse.
You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. The securities described above were offered and sold in this offering pursuant to a shelf registration statement on Form S-3 File No.
Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: H. This press release does not constitute an offer to sell, or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Iterum Therapeutics plcIterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements include all matters that are not historical facts.
Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. We will deploy these additional funds prudently to continue to build the business and strengthen the balance sheet. The Company is pursuing a rollup strategy of cannabis assets in mature markets.
The Company's website address is www. Although General Cannabis Corp believes that the expectations and assumptions on which such forward-looking statements are based are reasonable, caution must be exercised in relying on forward-looking statements because General Cannabis Corp can give no assurance that they will prove to be correct.
Actual results and developments may differ materially from those contemplated by these statements. Forward-looking statements are subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking statements. The statements in this press release are made as of the date of this release.
General Cannabis Corp undertakes no duty to update any forward-looking statements made herein. Contact:Steve Guttermansgutterman generalcann. Fantasy basketball expert Josh Lloyd looks at who might be available to give you the edge in your fantasy league. The Biden administration is backing off former president Donald Trump's attempts to ban the video app TikTok, asking a judge to postpone a legal dispute over the proposed ban as the government begins a broader review of the national security threats posed by Chinese technology companies.
A court filing says the US Commerce Department is reviewing whether Trump's claims about TikTok's threat to national security justified the attempts to ban it from smartphone app stores and deny it vital technical services. Now the first batch are shipping world wide and will be in the hands of eager users soon enough. One of Michigan's top Republicans stands by his false claims that it is a "hoax" to blame supporters of then-President Donald Trump for the Jan.
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