Osteoarthritis, Hip

New study shows promising results for allograft from Regenative Labs PENSACOLA, Fla., July 31, 2024 /PRNewswire/ -- More than 350,000 hip replacements are performed in the U.S. each year. Typically, patients in need of hip cartilage repairs seek minimally invasive options first, making Wharton's jelly a promising alternative for musculoskeletal defects. Continue Reading Albert Lai MD A recent study, titled Retrospective Evaluation of Cryopreserved Human Umbilical Cord Tissue Allografts in the Supplementation of Cartilage Defects Associated with Hip Osteoarthritis, showed that patients reported less pain and stiffness when receiving an application of a Wharton's Jelly allograft from Regenative Labs. The overall objective of this study was to evaluate the improvement of patient-reported pain, quality of life, and functionality scales after applying Wharton's jelly in hip defects. Dr. Albert Lai of Desert Pain Specialists and Centers of Rehabilitation and Pain Medicine in California and Dr. Conrad Tamea of Orthopedic Associates of Tampa Bay participated in the study. A double board-certified physician with specialties in physical medicine rehabilitation and pain medicine, Dr. Lai said the Wharton's jelly therapy was providing relief for their patients. "Incorporating Wharton's jelly into our practice has provided an effective conservative option for patients with hip defects that outperforms conventional therapies," said Dr. Lai. "Using the structural connective tissue allografts has allowed many patients to avoid surgery altogether and significantly improve their quality of life." The study follows 69 patients with hip defects from 26 private practices who received an application of a Wharton's jelly allograft from Regenative Labs. Prior to the study, these patients had failed at least 8 weeks of conservative treatment. Patient outcomes were tracked on a 90-day calendar using three scales including the Numeric Pain Rating Scale (NPRS), Quality of Life Scales (QOLS), and the Western Ontario and McMaster University Arthritis Index (WOMAC) covering pain, stiffness, and functionality. There were statistically significant differences between the initial application and day 90 for the NPRS and WOMAC scales. The application of Wharton's jelly allografts in this retrospective cohort was observed to promote decreases in patient-reported NPRS scores, pain and stiffness and to improve function. These improvements were consistent across age groups but were most notable for the elderly, who generally have a slower and less effective recovery rate after conservative treatment and surgical procedures. Because of the success shown by NPRS and WOMAC in decreasing pain in the elderly population, Regenative Labs CEO Tyler Barrett said more studies are warranted to evaluate the safety and efficacy of Wharton's Jelly, specifically in patients older than 65. "Total hip replacements by Medicare alone are estimated to make up somewhere between $7 billion to $10 billion in annual healthcare expenditures in the U.S. It's clear that the need for this type of research is necessary and quite frankly overdue," said Barrett. The positive results from this study and the current literature provide a foundation to study applications of Wharton's Jelly in other musculoskeletal injuries to ultimately improve the quality of life and reduce the economic burden of multiple conservative treatments or surgical procedures. Dr. Tamea said Wharton's jelly allografts have reduced pain and stiffness for his patients — and in some cases — reduced the need for surgery. "As a board-certified Orthopedic Surgeon with more than 25 years of operative experience, I can say after using Wharton's jelly allografts in more than 200 cases, I have found them to be extremely beneficial to my patients," said Dr. Tamea. "Orthopedic applications using Wharton's jelly — including in the knee, shoulder, hip, and spine — are more often than not preventing the need for surgery that results in a prolonged recovery time, lost wages and great financial cost." Barrett and the Regenative Labs' team hope to enlist physicians to take part in studies regarding uncovered uses. Physicians will have their outcomes highlighted, furthering the understanding of regenerative medicine and uncovering new applications for this groundbreaking field. Physicians can contact Regenative Labs to get their practice involved today. Read the full study here. Wharton's jelly explained: About Regenative Labs Regenative Labs produces regenerative medicine products to address the root cause of a patient's debilitating situation using Wharton's Jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with the daily challenges of innovations in healthcare, the company provides effective and minimally invasive options for patients. Regenative Labs' expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at About Dr. Albert Lai A southern Californian native, Dr. Lai completed his medical training at Tufts University, where he subsequently served as a clinical instructor. He is board certified in Physical Medicine and Rehabilitation. He also holds board certifications in Pain Medicine and Independent Medical Examiners. Dr. Lai has served as the managing partner at the offices of Desert Pain & Rehabilitation Associates based in Rancho Mirage for the past 18 years and as medical director of Centers of Rehabilitation and Pain Medicine in Placentia, California. Learn more at the Centers of Rehabilitation website: Pain Clinic Orange County | Professional Pain Management in OC (ocpain.net) About Dr. Conrad Tamea Dr. Tamea is a board-certified Orthopedic Surgeon, who now focuses solely on regenerative medicine. He received his education from the College of William and Mary, Drexel University, Hahnemann Medical University, and the University of Kansas Orthopedic Residency Program. Dr. Tamea utilizes his knowledge and experience from over three decades as a surgeon and over a decade of regenerative medicine and combines this knowledge with state-of-the-art equipment at his clinic at Orthopedic Associates of Tampa Bay. SOURCE Regenative Labs

Development program for the treatment of osteoarthritis (OA) chronic knee pain is fully funded through the first-in-human clinical study by a UG3/UH3 grant awarded by NIH/NINDS HEAL program Ongoing progress with IND-enabling studies of ADLR-1001 gene therapy for the treatment of OA chronic knee pain; Additional translational data expected before year-end Plans for data presentations at prominent scientific congresses and publications in premier journals expected throughout 2024 Scale-up of manufacturing process and production of the initial GMP batch for use in human clinical studies underway Company continues to expand patent estate across pipeline DELRAY BEACH, FL / ACCESSWIRE / May 21, 2024 / Adolore BioTherapeutics ("Adolore" or the "Company"), a biotechnology company focused on developing breakthrough opioid-free gene therapy treatments for chronic pain, today outlined recent pipeline development progress and provided a business outlook. Leveraging its innovative CA8*(*Carbonic anhydrase-like analgesic peptides, CA8 variants) gene therapy (ADLR-1001), Adolore is currently advancing two preclinical development programs: ADB-101 for the treatment of patients' chronic pain caused by erythromelalgia, an orphan disease, and our lead program for the treatment of patients with chronic pain caused by knee OA, ADB-102. Based on compelling preclinical data generated to date, the Company is progressing these programs towards IND filings and first-in-human clinical studies. Adolore's highly differentiated approach to treating chronic pain is based on two key innovative aspects: CA8* is a novel therapeutic protein that has the potential to benefit many millions of patients suffering from chronic pain, this in contrast to many other gene-therapy products that are often limited to serving just thousands of patients with rare genetic-defects. CA8* is an endogenous and potent non-opioid analgesic protein that acts within the sensory neuron and avoids the complications of opioids. Additionally, the Company's highly bio-engineered replication-defective HSV-derived vector intracellular delivery system (rdHSV) is highly selective for the targeted pain sensory cells and evades the immune system. With is strictly local delivery approach, Adolore has been able to observe a benign side-effect pro our preclinical studies, which the Company expects to translate into patients treated with ADLR-1001. This benign safety pro in stark contrast with the highly immunogenic AAV vectors that are currently most widely used for delivery of gene-therapies. "We continue to advance the development of our non-opioid analgesic gene therapies for the treatment of chronic pain and execute the most expedient path toward the clinic. While we are initially focused on our lead program, ADB-102 for chronic knee pain due to OA, we are also laying the groundwork for the use of our CA8*-products in other chronic pain indications including hip OA, Erythromelalgia (an Orphan Drug disease), diabetic neuropathy, post-herpetic neuralgia, and cancer pain among many other chronic pain conditions," commented Roelof Rongen, Chief Executive Officer of Adolore. "We are highly confident about the development advancements we will make in 2024 and 2025 and look forward to providing continued updates." Therapeutic Development Update The initial stage of the Company's development program for the treatment of chronic pain in knee osteoarthritis is fully funded by the NIH/NINDS HEAL UH3 Award to the University of Miami that supports all formal pre-clinical GLP/GMP/GCP development work, as well as a first-in-human clinical study in knee OA patients expected to commence in 2026. The NIH/NINDS awarded the UH3 HEAL CDMO contract to Advance Biological Laboratories (ABL, a subsidiary of Institute Merieux) in Rockville, MD for the development of the scale-up manufacturing process and production of the initial GMP batch for use in human clinical studies. Adolore is currently conducting its technology transfer, as well as facilitating the initiation of process and method development work at ABL, with the goal of developing the GMP-grade process and testing methods in 2024. This will enable production of toxicology and clinical batches in 2025. ABL's work will provide formal GLP-toxicology study drug and support the Company's IND filing for osteoarthritis, expected to take place in the first half of 2026. Adolore is also conducting additional pre-clinical animal studies, expected to read out later in 2024. The Company is grateful for the recognition by and support from the NINDS HEAL Program of its very versatile gene therapy technology for the treatment of chronic pain in the NIH's quest to support promising alternatives to opioid analgesics. Given the absence of better options, opioids are currently some of the most widely prescribed classes of pain medications and the cause of the widespread ongoing opioid crisis. Scientific Publications and Intellectual Property Roy Clifford Levitt, MD, Clinical Professor at the University of Miami, Principal Investigator and Program Director of the NIH, NINDS, HEAL Award supporting ADLR-1001 development for the treatment of chronic knee pain due to OA, and Founder & Executive Chairman of Adolore BioTherapeutics, recently submitted two manuscripts covering the mechanism of action, efficacy and safety of ADLR-1001 in preclinical studies. These findings included electrophysiological data demonstrating ADLR-1001 decreased pain-sensing neuronal excitability by activating Kv7 voltage-gated potassium channels (published earlier this month in Frontiers in Molecular Neuroscience). Kv7 channel activation is an accepted therapeutic target for treating chronic pain, including erythromelalgia. Additional publications of efficacy and safety data are expected in prominent peer-reviewed scientific journals in 2024. Moving forward, Adolore remains committed to generating a robust portfolio of scientific reports documenting the exceptional safety and efficacy of ADLR-1001. Additionally, the Company has made notable progress with advancing its intellectual property portfolio. As recently announced, the first U.S. patent covering its innovative CA8* gene therapy (U.S. patent No. 11,911,450) was issued. This patent and pending patent application family, covering the underlying CA8* gene therapy technology were licensed in 2023 by Adolore BioTherapeutics from the University of Miami, Miami, FL. The U.S. Patent and Trademark Office ("USPTO") granted 949 days of patent term restauration for the ‘450 patent which the USPTO projects will expire now in 2041. On the Vector/Cell system patents (licensed from the University of Pittsburgh), Adolore recently received a patent allowance in Korea and expects additional allowances in key markets around the world going forward. A U.S. patent has already been granted for the Vector/Cell system patent family. Financial Update On the financing front, the Company has raised additional cash of $1.0 million, bringing the total to $2.5 million in convertible debt raised so far. Based on management's current planning and expectations, the Company expects its cash reserves to fund operations through mid-2026. For more information, visit adolore.com and stay up to date with Adolore's latest news and events, connect with the Company on LinkedIn, Facebook and Twitter. About Adolore BioTherapeutics, Inc. Adolore BioTherapeutics, Inc., is a biotechnology company focused on developing novel therapies for the treatment of chronic pain and other pain and nervous system conditions or disorders. Our best-in-class programs are long-acting, locally acting gene-therapies that are opioid-free Disease Modifying Anti-Pain therapies (DMAPs) designed to treat many forms of chronic pain. The Company's current CA8* gene therapy programs are in preclinical development for treatment of patients suffering from erythromelalgia, a life-long heritable chronic pain condition representing an orphan drug disease with no approved therapy, and chronic pain due to knee osteoarthritis, affecting a large number of patients that are often treated with opioids due to the lack of good alternatives, thus contributing to the ongoing opioid crisis. For more information, visit adolore.com. Forward Looking Statements To the extent this announcement contains information and statements that are not historical, they are considered forward-looking statements within the meaning of the federal securities laws. You can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "should," "may," "plan," "intend," "assume" and other expressions which predict or indicate future events and trends and which do not relate to historical matters. You should not rely on forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, some of which are beyond the control of the Company. These risks and uncertainties include, but are not limited to, those associated with drug development. These risks, uncertainties and other factors may cause the actual results, performance or achievements of the Company to be materially different from the anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Investor Relations Contact JTC Team, LLC Jenene Thomas 833-475-8247 adolore@jtcir.com SOURCE: Adolore Biotherapeutics, Inc. 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STOCKHOLM, April 30, 2024 /PRNewswire/ -- Preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months. January – March Financial summary for the quarter Net turnover amounted to SEK 0.5 (0.4) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively. Cash flow from operating activities amounted to SEK -35.0 (-16.1) million. Cash and cash equivalents at the end of the period amounted to SEK 153.4 (100.8) million Significant events during the quarter In January Tango Therapeutics announced that it has dosed the first patient with TNG348, a new USP1-inhibitor from the preclinical USP1 program in-licensed from Medivir in 2020. Positive results from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression were presented at the ASCO GI Symposium in San Francisco. In January, a directed issue to Hallberg Management AB was carried out amounting to approximately SEK 20 million before deduction of issuance costs. In February, a change in Medivir's nomination committee announced as Anders Hallberg, appointed by Healthinvest Partners, leaves the nomination committee and is replaced by Stefan Bengtsson, appointed by CA Fastigheter AB. Events after the end of the period In April it was announced that Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701. In April it was announced that Medivir has completed a so-called Type C meeting with the FDA and that the company's preparations for the planned phase 2b study are continuing as planned, with a couple of adjustments in study design with limited impact on the timeline and size of the study. In April MIV-711 was granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), an uncommon hip disorder affecting children aged 2-12 years. Conference call for investors, analysts and the media The Interim Report January - March 2024 will be presented by Medivir's CEO, Jens Lindberg. Time: Tuesday, April 30, 2024, at 10.00 (CET). To access the webcast and find information about the teleconference, please click HERE! The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message "Our goal is that the combination of fostrox and Lenvima® shall become the first approved alternative in second-line for patients with primary liver cancer. Preparations for our planned phase 2b study continue after the Type C meeting with the FDA, strengthened by the fact that patients in the ongoing phase 1b/2a study continue to benefit from treatment with fostrox + Lenvima longer than expected and that the outcome continues to improve. Medivir's proprietary candidate drug fostrox is a targeted, smart chemotherapy that selectively kills cancer cells in the liver. Fostrox + Lenvima constitutes a unique, potential combination of complementary medicines that is showing promising results in Medivir's ongoing phase 1b/2a study. At the international ASCO-GI congress in San Francisco in January, results were presented for fostrox + Lenvima showing that the proportion of patients achieving a clinically relevant reduction in their liver tumor is greater than what would be expected with a second-line treatment. Data evaluated by investigators and local radiologists showed that the Objective Response Rate (ORR) was 25 percent (RECIST v1.1), a significantly higher rate than the 5–10 percent shown for second-line treatment of HCC in previous studies. The update also showed continued good tolerability without any new unexpected side effects. As the patients remain on treatment longer than expected, the clinical efficacy has continued to improve. At the time of writing, ~30 percent of patients remain on treatment in the study. The median time to progression has now increased further to 7 months, compared to 5 months at ASCO GI, significantly longer than previous studies in second-line HCC have shown. The patient who has benefited the longest remains on treatment after 20 months with continued partial response. The readout of the study as a whole is expected to be completed by the end of 2024, depending on how long the last patients continue to benefit from the treatment. Our data has been met with great interest and the discussions with leading global experts, not least at ASCO GI, have confirmed what the combination fostrox + Lenvima could mean in the second-line treatment of HCC, where patients today are without any approved treatment alternative. With the increasingly exciting data from the study, the opportunity emerges to become the first approved drug treatment in a market worth ~$2.5 billion annually. We have therefore put in a higher gear to ensure maximum speed forward in fostrox's development program to create the possibility of a so-called accelerated approval. Somewhat simplified, it can be described as a conditional regulatory approval that enables prescribing to patients where the data must later be substantiated in a follow-up confirmatory phase 3 study. This means an opportunity for fostrox to reach patients up to three years faster than would otherwise be the case. During the quarter, we also had a Type C meeting with the FDA to discuss the study design. The FDA provided clarifying guidance, which means we are now approaching the final study design for the planned phase 2b study, which is proceeding as previously planned. Parallel to these measures, the discussions we are having with potential cooperation partners for fostrox continue. Also, when it comes to the projects Medivir previously licensed out to partners, the development is exciting. In January, Tango Therapeutics initiated a phase 1/2 study and dosed the first patient with TNG348, a USP-1 inhibitor developed from the preclinical USP1 program in-licensed from Medivir in 2020. In April, our partner Vetbiolix, a veterinary biotech company based in France, could report positive results from a clinical Proof-of-Concept study in canine periodontitis disease with its drug candidate VBX-1000, formerly known as MIV-701 which was out-licensed to Vetbiolix in 2019. In addition, our project for partnership MIV-711 was granted Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. Aside from that this creates opportunity for partnerships and future revenue, it also demonstrates the quality of Medivir's research. The continued clinical development of fostrox is our focus and the promising data showing further improvement in clinical efficacy in second-line HCC reinforces our belief that fostrox can become an effective anti -cancer drug that makes a real difference to patients. There is a clear need and an obvious place for fostrox in the treatment landscape. The goal is to become the first approved alternative in second-line for patients with primary liver cancer. I look forward to keeping you informed of Medivir's continued development." Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: [email protected] This report has not been subject to auditors' review. The information was submitted for publication at 08.30 CET on April 30, 2024 This information was brought to you by Cision The following files are available for download: SOURCE Medivir