Latest news with #MichaelHaller
Time of India
7 days ago
- Health
- Time of India
Inhaled insulin as good as injection for children at mealtime
London: Children with diabetes who inhaled their mealtime doses of insulin did just as well as those who injected insulin under the skin, researchers reported at the American Diabetes Association scientific meeting in Chicago. To regulate their blood sugar, patients with type 1 diabetes usually require an injection of a long-acting basal insulin once a day, plus additional injections of rapid-acting insulins at mealtimes. MannKind's inhaled insulin Afrezza is approved for use by adults but not yet for children, which prompted the study. The 230 children with type 1 diabetes, ages 4 to 17, who participated in the trial received either Afrezza at mealtimes, or their usual mealtime injections of insulin, for 26 weeks. Everyone continued to receive their basal insulin injections. Control of hemoglobin A1c, a marker of blood sugar control over the past several months, was comparable with the inhaled insulin and the injected insulin, the researchers found. Inhaled insulin was also associated with less weight gain and slightly higher child and parent preference scores. The inhaled formula did not have any adverse effects on patients' lungs, the researchers reported. "Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin," study leader Dr. Michael Haller of the University of Florida said in a statement. "Afrezza should be available as an option to all children and adults with type 1 diabetes." ONCE-WEEKLY INSULIN PROMISING FOR TYPE 2 DIABETES Eli Lilly's experimental once-weekly insulin efsitora was comparable to daily insulins in nearly a thousand adults with type 2 diabetes in three late-stage trials, researchers reported at the ADA meeting. The trials, which were designed to study patients at different stages of insulin use, each found efsitora to be just as effective as daily insulins for bringing HbA1c levels - a common measure of blood sugar over time - under control. "Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Lilly's senior vice president of product development, Jeff Emmick, said in a statement. One trial, reported in The New England Journal of Medicine, involved patients with type 2 diabetes who were using insulin for the first time. A second trial in patients who had been using daily basal insulin degludec and a third trial in those who had been taking basal insulin glargine plus extra mealtime insulin doses were both reported in The Lancet. Efsitora "has the potential to facilitate and simplify insulin therapy , reducing the hesitation often associated with starting insulin to treat type 2 diabetes," Dr. Julio Rosenstock of University of Texas Southwestern Medical Center, who led one of the studies, said in a statement. People newly diagnosed with type 2 diabetes usually start treatment with oral medications, but roughly one-third of them will need to use insulin within 8 years of their diagnosis, according to an editorial in The Lancet. GENETICALLY ENGINEERED SKIN GRAFTS TREAT BLISTERING DISEASE Long-lasting wounds from a painful genetic skin disease can be healed with skin grafts genetically engineered from a patient's own cells, researchers reported in The Lancet. In severe dystrophic epidermolysis bullosa , or EB, the skin is so fragile the slightest touch - even from clothing - causes blistering and wounds, eventually leading to large, open lesions that never heal. "With our novel gene therapy technique, we successfully treated the hardest-to-heal wounds, which were usually also the most painful ones for these patients," study leader Dr. Jean Tang of Lucile Packard Children's Hospital Stanford in Palo Alto, California said in a statement. Severe dystrophic EB is caused by a defect in the gene for collagen VII, a protein that normally holds the skin together. As a result, the layers of the skin separate in response to even slight friction. To create the personalized skin grafts, doctors take a small biopsy sample of the patient's un-wounded skin and introduce a corrected version of the collagen VII gene to the skin cells. These cells are then grown into sheets of healthy skin. For the late-stage study, 11 patients with recessive dystrophic EB had a total of 43 wounds treated with grafts. For each treated wound, the researchers also identified a comparable "control" wound on the same patient that was managed with traditional measures. Six months later, 81% of treated wounds were at least half healed, compared with 16% of control wounds. Roughly two-thirds of treated wounds were at least three-quarters healed, compared with 7% of control wounds, and 16% of treated wounds had completely healed, compared with none of the control wounds. In addition, grafted areas had less pain, itching and blistering. The same research team had previously developed a gene therapy gel for treating smaller EB wounds. "I hope that if these patients are diagnosed as infants and start the gene therapy gel, maybe they won't develop big wounds," Tang said. "But if the gels don't work and a wound does expand, the skin graft therapy is the right treatment. The life arc of their disease will, I hope, be modified, with less suffering." An editorial published with the study notes that EB patients who participated in early-stage trials of the skin grafts still had decreased blistering and wounding, pain, and itch at grafted sites five years later. In April, the U.S. Food and Drug Administration granted Abeona Therapeutics approval for the skin grafts as an EB therapy. (To receive the full newsletter in your inbox for free sign up here)
Yahoo
23-06-2025
- Business
- Yahoo
MannKind (MNKD) Presents Pediatric Insulin Trial Data
MannKind Corporation (NASDAQ:MNKD) is one of the 11 Best US Stocks to Invest in Under $5. MannKind Corporation (NASDAQ:MNKD) reported that it will present its inhaled insulin product at the American Diabetes Association's 85th Scientific Sessions, which is taking place from June 20 to June 23 in Chicago. During a 'Future Ready' symposium, Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will share results from the randomized period of the INHALE-1 clinical trial. Dr. Haller also serves as the Chair for MannKind Corporation's (NASDAQ:MNKD) Phase 3 INHALE-1 study of Afrezza, an inhaled insulin powder, in children and adolescents between 4 and 17 years old. A close-up of a doctor's hand pressing on an inhaler, conveying the effect of the company's therapeutic products. MannKind Corporation (NASDAQ:MNKD) aims to release the topline results from the full pediatric study with safety extension in the second quarter of 2025. The company also expects to submit a Supplemental Biologics License Application in mid-2025 for a possible pediatric indication for Afrezza. MannKind Corporation (NASDAQ:MNKD) is a biopharmaceutical company focused on developing and commercializing innovative inhaled therapeutic products and devices for those living with endocrine and orphan lung diseases. While we acknowledge the potential of MNKD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 11 Stocks That Will Bounce Back According To Analysts and 11 Best Stocks Under $15 to Buy According to Hedge Funds. Disclosure: None.
Yahoo
28-01-2025
- Business
- Yahoo
SAB BIO Announces R&D Webinar Event to Review Phase 1 Topline Results for SAB-142, a Disease-Modifying T1D Therapy
Investor webinar scheduled Tuesday, January 28, 2025, at 8:00 AM EST MIAMI, Jan. 23, 2025 (GLOBE NEWSWIRE) -- SAB BIO (Nasdaq: SABS), ('SAB' or the 'Company'), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D), announced today that the Company will host a Research and Development webinar on January 28, 2025 to discuss the topline data for Phase 1 clinical trial for its lead candidate, SAB-142. The webinar will feature presentations from SAB BIO's management team and T1D Key Opinion Leader (KOL) Michael Haller, MD, the division chief of the Pediatric Endocrinology Division at the University of Florida and Silverstein Family Eminent Scholar Chair in Pediatric Endocrinology. Webinar Details and Registration Information Date: Tuesday, January 28, 2025 Time: 8:00 am ET Register for the event here or join the conference call through the Events section of the SAB BIO Company website. A live question and answer session will follow the formal presentations. A replay of the call will be available in the Presentation section of the SAB BIO Company website upon conclusion of the event. About the Phase 1 Trial for SAB-142 The Phase 1 trial of SAB-142 is designed as a randomized, double-blind, placebo-controlled, single-ascending dose, adaptive design clinical study in healthy volunteers and participants with T1D. The objectives of the study include establishing the safety, tolerability, pharmacokinetic (PK), immunogenicity and pharmacodynamic (PD) profile for SAB-142. 'I look forward to sharing topline results of our Phase 1 trial for SAB-142 alongside an internationally recognized expert in diabetes research, Dr. Michael Haller,' stated Samuel J. Reich, Chairman and CEO of SAB BIO. 'SAB-142 is a therapy with the potential to transform patients' lives through the delay or prevention of the onset of type 1 diabetes, and this event will be an opportunity to discuss clinical milestones and in-depth data results of this important trial.' About SAB BIO SAB BIO (SAB) is a clinical-stage biopharmaceutical company focused on developing human, multi- targeted, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent immune and autoimmune disorders. The Company's lead asset, SAB-142, targets T1D with a disease-modifying therapeutic approach that aims to change the treatment paradigm by delaying onset and potentially preventing disease progression. Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB's DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors. For more information on SAB, visit: and follow SAB on X and LinkedIn. Forward-Looking Statements Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as 'believe,' 'may,' 'will,' 'to be,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'should,' 'would,' 'plan,' 'predict,' 'potential,' 'seem,' 'seek,' 'future,' 'outlook,' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including, the impact members of SAB's leadership team will have on the Company's business and results of operations, the exercise of outstanding warrants for cash, our expected cash runway and the development and efficacy of our T1D program and other discovery programs. These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry's results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned 'Risk Factors' in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. CONTACTS Media Relations:Kaelan HollonVice President of Communications khollon@ Investor Relations:Kevin GardnerLifeSci Advisorskgardner@ Chris CalabreseLifeSci Advisorsccalabrese@
