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Ocugen Highlights Modifier Gene Therapy Platform at Cell & Gene Meeting on the Mesa

  • Ocugen's CEO, Dr. Shankar Musunuri, presented the company's modifier gene therapy platform at the 2024 Cell & Gene Meeting on the Mesa.
  • The presentation included updates on OCU400 for retinitis pigmentosa (Phase 3), OCU410 for geographic atrophy (Phase 2), and OCU410ST for Stargardt disease (Phase 1/2).
  • Ocugen remains on track for a 2026 BLA and MAA approval target for OCU400, with Phase 3 dosing currently underway.
  • Ocugen's executive team also conducted one-on-one meetings to discuss the company’s business and clinical development strategy.

Amsel Medical Awarded $7.45M Phase III SBIR Contract for Hemorrhage Control Device

  • Amsel Medical secures a $7.45 million Phase III SBIR contract from the U.S. Air Force to advance its SCureTO™ hemorrhage control solution.
  • The SCureTO™ device offers rapid, minimally invasive arterial clamping for acute and prolonged hemorrhage control, especially in junctional injuries.
  • This technology aims to improve survival rates in both military and civilian trauma settings by extending the "golden hour" for safe evacuation.
  • The contract supports the commercialization of SCureTO™, addressing a critical need for prehospital hemorrhage control and limb preservation.

Genenta Science's Temferon Receives Approval for Phase 1 Trial in Metastatic Renal Cell Carcinoma

• Genenta Science has received AIFA approval for a Phase 1 clinical trial of Temferon™ in metastatic Renal Cell Cancer (mRCC). • The mRCC trial, set to begin in Q4 2024, will target high-risk patients with limited survival after multiple therapies. • Prior Phase 1 trial of Temferon™ in Glioblastoma Multiforme (GBM) showed a 25% increase in 2-year overall survival. • Preclinical data indicates Temferon™ demonstrates synergy with other immunotherapies in solid tumors, enhancing its potential.

Time-Restricted Eating Improves Metabolic Health in Adults with Metabolic Syndrome

  • A clinical trial reveals that time-restricted eating (TRE) improves cardiometabolic health markers in adults with metabolic syndrome.
  • Participants following an 8-10 hour eating window showed improvements in blood sugar, cholesterol, and body weight compared to standard treatment.
  • The TIMET study demonstrates TRE's potential as a practical, low-cost intervention alongside existing treatments for metabolic syndrome.
  • Personalized TRE protocols, tailored to individual schedules, enhance adherence and effectiveness in managing metabolic dysfunction.

Surmodics' Pounce XL Thrombectomy System Receives FDA Clearance

  • Surmodics has received FDA 510(k) clearance for its Pounce XL Thrombectomy System, expanding its Pounce platform for peripheral artery thrombus removal.
  • The Pounce XL is designed for use in 5.5–10mm diameter vessels, including iliac and femoral arteries, addressing a broader range of vessel sizes.
  • Surmodics plans a limited market release in the first half of 2025, aiming to provide a comprehensive mechanical thrombectomy solution without thrombolytics.
  • The Pounce platform offers rapid blood flow restoration, potentially reducing the need for follow-up procedures and intensive care admissions.

Insilico Medicine Named a Fierce 50 Honoree for AI-Driven Drug Discovery

• Insilico Medicine has been recognized as a Fierce 50 honoree for its pioneering work in AI-driven drug discovery and development. • The company's Pharma.AI platform has facilitated the nomination of 20 preclinical candidates, with 9 molecules receiving IND approval. • Positive Phase IIa trial results for ISM001_055, an AI-discovered and designed drug, showed favorable safety and dose-dependent efficacy in patients. • This award highlights Insilico's commitment to using AI and robotics to accelerate the creation of innovative therapies for unmet medical needs.

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

NCT05938920Active, Not RecruitingPhase 2
InSilico Medicine Hong Kong Limited
Posted 6/19/2023

HER2-Directed ADCs Expand Treatment Spectrum Across Solid Tumors

• Trastuzumab deruxtecan (T-DXd) shows promise across breast, gynecologic, gastrointestinal, lung, and genitourinary cancers, targeting HER2-positive, -mutated, and -amplified diseases. • In gynecologic cancers, the DESTINY-PanTumor02 trial demonstrated significant response rates with T-DXd in endometrial, cervical, and ovarian cancers, particularly in HER2 IHC3+ patients. • T-DXd has received FDA approval for HER2-mutant NSCLC and HER2-positive solid tumors, marking advancements in targeted therapies for previously hard-to-treat cancers. • Clinical trials like DESTINY-Breast03 and DESTINY-Gastric01 support T-DXd's efficacy, showing improved PFS and OS compared to standard treatments in breast and gastric cancers.

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

NCT04379596RecruitingPhase 2
AstraZeneca
Posted 6/3/2020

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT04644237CompletedPhase 2
Daiichi Sankyo
Posted 3/19/2021

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

NCT03529110Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 8/9/2018

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT02289833CompletedPhase 2
Hoffmann-La Roche
Posted 12/15/2014

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

NCT04538742Active, Not RecruitingPhase 1
AstraZeneca
Posted 12/28/2020

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

NCT04482309RecruitingPhase 2
AstraZeneca
Posted 8/18/2020

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

NCT00829166CompletedPhase 3
Hoffmann-La Roche
Posted 2/1/2009

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

NCT01772472CompletedPhase 3
Hoffmann-La Roche
Posted 4/3/2013

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

NCT03329690CompletedPhase 2
Daiichi Sankyo Co., Ltd.
Posted 11/2/2017

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/24/2020

Flashing Lights and Gamma Waves: A Novel Approach to Stalling Alzheimer's

• Researchers are exploring the use of flashing lights and rhythmic sounds to stimulate gamma waves in the brain, potentially combating Alzheimer's disease. • Early clinical trial data shows encouraging evidence of neuroprotection and cognitive benefits with 40-hertz sensory stimulation, without serious side effects. • A large, randomized trial involving over 600 participants is underway to further validate the efficacy of this unconventional therapy. • Concerns exist regarding unregulated 'wellness' devices that market similar technology, potentially outpacing scientific validation and harming consumers.

Deep Brain Stimulation Shows Promise in Restoring Arm and Hand Function After Brain Injury

  • New research demonstrates that deep brain stimulation (DBS) could help patients regain arm and hand function after stroke or traumatic brain injury.
  • The study found that DBS of the motor thalamus significantly improved muscle activation and grip strength in both monkeys and a human volunteer.
  • The participant with arm tremors caused by brain injury was able to lift weights and grasp objects more efficiently with DBS.
  • Researchers are now studying the long-term effects of DBS and whether continued stimulation can further improve upper-limb motor function.

Fizzy Drinks and Fruit Juice Linked to Increased Stroke Risk, Water May Lower Risk

  • A global study of nearly 27,000 people links carbonated drinks to a 22% higher risk of stroke, with risk rising sharply with two or more drinks a day.
  • Fruit juice drinks were found to boost the odds for a bleeding stroke by 37%, with the risk tripling with two or more drinks a day, especially in women.
  • Drinking more than four cups of coffee a day was associated with a 37% increase in stroke risk, while drinking more than seven cups of water daily may reduce the risk of stroke caused by a blood clot.
  • Researchers advise minimizing fizzy and fruit drinks, opting for water, and being cautious about fruit juices made from concentrates with added sugars and preservatives.

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