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Prevail Infoworks •

The future of cancer is now.

Six CAR-T cell therapies are now approved in the US, and cell therapy’s impact on cancer care is growing at a rapid pace. One of the next goals in cell therapy is to improve efficiency by reprograming patients’ cells in vivo – that is, inside their own bodies. How do you think the evolution of CAR-T cell therapy is impacting lives and medicine as we know it? “The promise of changing the ability of a cell to alter the course of disease with a simple injection is very exciting and helped tremendously by efforts and success of the Covid-19 mRNA vaccines.” #celltherapies #CARtcelltherapy #mRNA #bioscience

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HIV vaccine being developed by Johnson & Johnson and the U.S. National Institute of Health fails clinical trial

An experimental HIV vaccine being developed by Johnson & Johnson and the U.S. National Institute of Health wasn’t effective at preventing infection in a large study, independent trial monitors determined after reviewing initial results. The trial will be discontinued as a result. What do you think will be the next step for researchers in preventing infection? “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV.” - Penny Heaton, M.D., Global Therapeutic Area Head for Vaccines at Janssen #HIVvaccine #HIV #HIVprevention #clinicaltrial https://lnkd.in/eWmhYZ2y

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The rollout and readout of Alzheimer drugs is one of the biggest biotech trends that is shaping 2023.

The accelerated approval of lecanemab, branded as Leqembi, signaled a hopeful development for the treatment of Alzheimer’s disease. What else do you think is on the horizon for Alzheimer’s disease treatment? “Beta amyloid directed antibodies have become one of the most controversial drug classes in recent history,” said Fady Riad, CEO of the consulting firm Centurion Life Sciences. “The approval of Aduhelm in 2021 led to significant scrutiny with regards to the efficacy and safety profiles of this drug and its entire class.” #Alzheimersdisease #biotech #Alzheimers hashtag#Alzheimerstreatment https://lnkd.in/evUdeFEs

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Awakn Initiates Investigative Study Of Novel Formulation Of (S)-Ketamine to assess dissociative effect.

The thoughtful team Awakn Life Sciences initiated an investigative study of a novel formulation of (S) – Ketamine to assess dissociative effect. Awakn is a biotechnology company focused on developing therapeutics to treat addiction. With a near-term focus on Alcohol Use Disorder (AUD), the study’s participants will consist of harmful drinkers. If the results of this study are positive, it will potentially lead to a global licensing agreement of their patent pending oral thin film (S) – Ketamine formulation. Anthony Tennyson, Awakn CEO said, “This is an exciting development for Awakn which we believe will strengthen our innovative pipeline of therapeutics. Critically, it also has the potential to improve treatment options and experiences for so many people suffering from Alcohol Use Disorder, with so few effective options available to them, there has never been a greater need.” #AlcoholUseDisorder #therapeutics #Phase1 #Ketamine https://lnkd.in/eUeQagei

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Sparrow Pharmaceuticals Announces First Patient Dosed in RESCUE, a Phase 2 Clinical Trial

The devoted team Sparrow Pharmaceuticals, Inc., dedicated to developing innovative therapies to address unmet needs in both endocrinology and rheumatology, are excited to share some great news. The first patient has been dosed in the phase 2 clinical trial, for the treatment of ACTC-dependent Cushing’s syndrome. “Dosing our first patient in this phase 2 trial is an important milestone in our clinical development process of SPI-62. Cushing is a devastating rare disease with debilitating morbidities such as depression, bone loss, and diabetes, and if left untreated, high levels of mortality. Current treatments have limited efficacy or serious side effects, so there is a pressing need for new treatments that help these patients mitigate the effects of hypercortisolism.” -Frank Czerwiec, MD, PhD, Chief Medical Officer of Sparrow #biopharma #cushingssdynrome #clinicaltrial #depression #diabetes #hypercortisolism

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XORTX Announces Positive Topline Results from XRX-OXY-101 Clinical Trial

The forward-thinking team at XORTX Therapeutics Inc. Therapeutics is pleased to announce some exciting news. The late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, generated positive topline results from the XRY-OXY 101 clinical trial. Results from the study showed that XORLO was well tolerated across the various dosing regiments and no safety issues were identified in the four parts of the study. “We are pleased to have achieved this important milestone in the development of XORLO, the Company’s proprietary oral formulation of oxypurinol. The comprehensive characterization of this drug and its unique proprietary formulation provides a substantial understanding of how the XORLO formulation behaves pharmacokinetically in individuals.” -Dr. Allen Davidoff, CEO of XORTX #kidneydisease #biotech #newtherapies #clinicaltrial https://lnkd.in/evMtjnqy

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The diligent team at Intrommune Therapeutics is pleased to announce its completion of enrollment in the Phase 1 OMEGA Study for peanut allergy.

The results of this 48-week trial will provide long-term safety data and inform the starting dose while further defining the clinical profile of INT301. INT301 is a novel peanut desensitization immunotherapy formulated in a fully functioning toothpaste conveniently administered during a patient’s daily toothpaste routine. https://lnkd.in/ewMaeH4A “Fully enrolling the OMEGA Clinical Study is a significant milestone for Intrommune as we continue to progress our innovative platform of products to help patients with food allergies, including peanut allergies.” – Michael Nelson, CEO of Intrommune Therapeutics #biotech #foodallergy #foodallergyawareness #Phase1 #peanutallergy

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Prevail InfoWorks is proud to be the full service Clinical Research Organization for BriaCell Therapeutics Corp.'s upcoming pivotal study.

Expected to commence in 2023, the advanced metastatic breast cancer study will be utilizing Prevail’s clinical site coordination, project management, clinical monitoring and pharmacovigilance (safety management) services, and proprietary integrated real-time data analytics platform, The Single Interface®, for clinical support and real-time data analysis. Please take a look at the below press release, as picked up by Bloomberg: https://lnkd.in/evYWNU6q #Briacell #clinicaltrials #CRO #cancer #oncology #Prevail

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Prevail InfoWorks •

Prevail’s clinical experts are here to support your trial from start to finish every day.

As a CRO/FSP based in Philadelphia, there is local excitement about the Eagles being Super Bowl bound. One of their advantages, noted by ESPN, is that “every decision the Philadelphia Eagles make as an organization is informed by analytics, including the most consequential in-game decision in franchise history.” To inform your decisions throughout your clinical studies, give yourself the same advantage by using the patented Single Interface® to make early observations and analysis of your data in real time, without alpha spend. After all, that in-game decision was the “Philly Special” when the Eagles successfully “went for it” on 4th and goal on their way to winning Super Bowl LII. Visit our website today to schedule an interactive walkthrough: https://lnkd.in/eQG8K63T #Biotechnology #Data #ClincialTrials #Efficacy