FIH

Myrtelle Announces Presentation at Hydrocephalus Association & Rudi Schulte Research Workshop on Developing Non-Invasive Hydrocephalus Therapies: Molecular and Cellular Targets

Retrieved on: 
Thursday, September 28, 2023
Health, Neurology, Genetics, Clinical Trials, Research, Science, Biotechnology, CD, Canavan disease, Inc., Natural history, Gene, Clinical trial, Mutation, ASPA, Associate, Chromosome 11, MRI, Magnetic resonance imaging, Patient, Preyasi Raave, White matter, Hydrocephalus, FIH, Medical imaging

These improvements in treated patients contrast the deterioration in untreated age-matched CD patients based on natural history.

Key Points: 
  • These improvements in treated patients contrast the deterioration in untreated age-matched CD patients based on natural history.
  • MRI-based improvements are correlated with improvements in motor and cognitive function in treated patients, which will be presented at upcoming conferences.
  • In CD, normal brain development is impaired due to a mutation in the ASPA gene that encodes the enzyme aspartoacylase.
  • The oligodendrocyte-targeting rAAV vector-based gene therapy is intended to restore ASPA function and brain development in patients with CD.

EnCompass receives FDA conditional IDE approval to commence a US pilot study of its F2 cerebral embolic protection (CEP) system in patients undergoing transcatheter aortic valve replacement (TAVR)

Retrieved on: 
Wednesday, September 27, 2023
Boston Scientific, US Foods, Investigational device exemption, Society, Interventional neuroradiology, Encompass Technologies, F2, Stroke, Quality of life, Brain, Calcium, Patient, TAVR, FIH, IDE, Longevity, UCLA, FDA, Embolism, Food, CEP, Medical device, Medical imaging, Encompass

All cardiovascular procedures cause the release of particulate debris (calcium, vessel wall, blood clot) and air bubbles, called emboli.

Key Points: 
  • All cardiovascular procedures cause the release of particulate debris (calcium, vessel wall, blood clot) and air bubbles, called emboli.
  • During the TAVR procedure, 360-degree wall apposition of the F2 filter in the aortic arch is designed to prevent migration.
  • Because the F2 filter is attached to a self-expanding nitinol stent, it is easy to insert, deploy, and retrieve.
  • In September 2023, a similar pilot study began in Australia and now with FDA conditional IDE approval, EnCompass plans to commence its first US pilot study.

Xencor to Present Multiple Posters at the SITC Annual Meeting

Retrieved on: 
Wednesday, September 27, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Society, Cancer, SITC, Immunotherapy, Antibody, Patient, FIH, Poster, Cytokine, Vaccine

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced three poster presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held in San Diego, November 1-5, 2023.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced three poster presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held in San Diego, November 1-5, 2023.
  • Abstract 764, “A Phase 1, first-in-human (FIH), open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors”
    Posters will be available in the poster hall and virtually to registrants of the SITC Annual Meeting, beginning at 9:00 a.m. PT on Friday, November 3.
  • In the poster hall, odd-numbered posters will be displayed on Friday, November 3, and even-numbered posters will be displayed on Saturday, November 4.
  • Posters will be archived under “Events & Presentations” in the Investors section of the Company’s website located at www.xencor.com .

Benitec Biopharma Releases Full Year 2023 Financial Results and Provides Operational Update

Retrieved on: 
Thursday, September 21, 2023
Oculopharyngeal muscular dystrophy, REB, Dysphagia, Natural history, Oropharyngeal dysphagia, Principal investigator, RNA-dependent RNA polymerase, Form 10-K, Research, RNA, Investigational New Drug, 52 Weeks Make A Year, HIV disease progression rates, FIH, Dispute board, FDA, Annual report, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Clinical, Food, Safety, Nursing, Pharmaceutical industry, Medical imaging, Health insurance, Cryptocurrency, Benitec Biopharma, OPMD

HAYWARD, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary DNA-directed RNA interference ("ddRNAi") platform, today announced financial results for its Fiscal Year ended June 30, 2023. The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2023, with the U.S. Securities and Exchange Commission.

Key Points: 
  • The Company has filed its annual report on Form 10-K for the quarter ended June 30, 2023, with the U.S. Securities and Exchange Commission.
  • Dosing with BB-301: 1-day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study.
  • In December 2022, Benitec began screening OPMD subjects at the lead clinical study site in the United States.
  • In January 2023, Benitec announced the enrollment of the first OPMD subject into the OPMD NH Study in the United States.

Microbot Medical Gains Global Recognition; Professor Vincent Vidal to Present an Abstract on The LIBERTY® Robotic Surgical System at CIRSE 2023

Retrieved on: 
Friday, September 8, 2023
Cardiovascular and Interventional Radiological Society of Europe, Miniature, ZEUS robotic surgical system, Clinical trial, Coronavirus Scientific Advisory Board, CIRSE, Doctor of Philosophy, Aix-Marseille University, MDR, Professor, Circulatory system, FIH, FDA, Microbotics

BRAINTREE, Mass., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) is honored to announce the continuous growing global recognition of its LIBERTY® Robotic Surgical System, to be presented in an abstract at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 9, 2023.

Key Points: 
  • BRAINTREE, Mass., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) is honored to announce the continuous growing global recognition of its LIBERTY® Robotic Surgical System, to be presented in an abstract at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 9, 2023.
  • The abstract is to be presented by Professor of Interventional Radiology Vincent Vidal, M.D.
  • PhD, from the Aix-Marseille University and a Scientific Advisory Board Member of Microbot.
  • The team expressed their positive experiences and satisfaction from using the Company’s Robotic Surgery System.

Trevena Announces Preliminary TRV045 Data from Two Proof-of-Concept Studies Evaluating S1PR Mechanism of Action and CNS Target Engagement

Retrieved on: 
Wednesday, September 6, 2023
Epilepsy, Learning, Male, Senior, TMS, Sleep, EMG, Brain, CNS, RMT, Arousal, MEP, Plasma, Central nervous system disease, EEG, Webcast, FIH, POC, Headache, Memory, Skin, Safety, Medical imaging, Pharmaceutical industry

CHESTERBROOK, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced preliminary topline data from two Phase 1 proof-of-concept studies of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1.

Key Points: 
  • TRV045 did not show a statistically significant difference or trend compared to placebo in other pain modalities.
  • The goal of the study was to provide further insight into TRV045 CNS target engagement and mechanism of action for the potential treatment of epilepsy and other CNS disorders.
  • This statistically significant increase in power was observed in the frontal region for beta waves (P=0.0235) and gamma waves (P=0.0343).
  • Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.

TransCode Therapeutics Announces First Subject Dosed with Radiolabeled TTX-MC138 in First-In-Human Clinical Trial

Retrieved on: 
Wednesday, August 23, 2023
Triple-negative breast cancer, TNBC, Glioblastoma, Therapy, Drug discovery, Clinical trial, Cancer, Pharmacokinetics, Hope, Transcoding, Breast, RNA, Investigational New Drug, Animal, FIH, Recurrence, Metastasis, Safety, TTX, Pharmaceutical industry, Medical imaging

BOSTON, Aug. 23, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced the dosing of the first subject in its First-in-Human Phase 0 clinical trial.

Key Points: 
  • BOSTON, Aug. 23, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced the dosing of the first subject in its First-in-Human Phase 0 clinical trial.
  • The subject received a single subtherapeutic dose of radiolabeled TTX-MC138 and appeared to tolerate the dosing well.
  • “We are pleased to have commenced our First-in-Human (FIH) clinical trial,” said TransCode’s Chief Executive Officer and co-founder, Michael Dudley.
  • The trial could yield critical data regarding therapeutic dosing, timing, and potential safety that could inform later clinical trials, including a Phase 1 trial planned to commence in 2024.

Advanced NanoTherapies (ANT) Secures $4M Strategic Investment to Accelerate Clinical Development of SirPlux Duo Drug-Coated Balloon (DCB) for Treating de novo Coronary Artery Disease (CAD)

Retrieved on: 
Tuesday, August 22, 2023
Auckland City Hospital, Cleveland Clinic, Cleveland Clinic Akron General, Structural heart disease, Restenosis, CAD, Paclitaxel, Doctor of Philosophy, De novo, DCB, Sirolimus, Interventional cardiology, MD, Patient, DCB Bank, Vascular disease, ANT, Education minister, FIH, Entrepreneurship, LOS, Coronary artery disease, Nanotechnology, Safety, Pharmaceutical industry

LOS GATOS, Calif., Aug. 22, 2023 /PRNewswire/ -- Advanced NanoTherapies Inc. (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through the creative applications of nanotechnology, today announced a $4M Series A extension from a prominent undisclosed strategic medical device company. Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB). The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).

Key Points: 
  • Additionally, ANT successfully treated the first cohort of study participants in its ADVANCE-DCB first-in-human (FIH) trial, demonstrating initial short-term safety data for the next-generation SirPlux Duo Drug-Coated Balloon (DCB).
  • The trial is evaluating the safety and performance of the SirPlux Duo DCB in de novo coronary artery disease (CAD).
  • "Today, we celebrate two remarkable accomplishments for ANT and SirPlux Duo DCB," said Marwan Berrada, Co-Founder and CEO of ANT.
  • "I welcome the participation of a new strategic partner as this additional investment will bolster ANT's clinical programs and accelerate the path toward U.S. IDE approval for the SirPlux Duo DCB.

BaroPace, Inc. Announced First Patient Enrolled in Non-Pharmacologic Hypertension and Heart Failure Treatment Trial

Retrieved on: 
Tuesday, August 22, 2023
Health, Medical Devices, Health Technology, General Health, Clinical Trials, Cardiology, Biotechnology, Blood pressure, Exercise, Heart failure, Atrial fibrillation, Clinical trial, Quality of life, Heart failure with preserved ejection fraction, Hypertension, Patient, FIH, Longevity, Human, Safety, Medical device

Pacemaker programming adjustments are made twice daily at the patient’s home in the treatment group (BaroPacing) with sham programming performed in the standard treatment (placebo) group.

Key Points: 
  • Pacemaker programming adjustments are made twice daily at the patient’s home in the treatment group (BaroPacing) with sham programming performed in the standard treatment (placebo) group.
  • Primary endpoints of the trial are safety, improved exercise performance (modified BRUCE treadmill protocol and six-minute walk test), and the Minnesota Living with Heart Failure Questionnaire.
  • Secondary endpoints include blood pressure control (systolic and diastolic blood pressure and 24-hour blood pressure monitoring), atrial fibrillation incidences, and hospitalization frequency.
  • "We’re pleased to initiate this First-in-Human trial of PressurePace™,” said Michael Burnam MD, BaroPace’s Co-founder and CEO.

TransCode Therapeutics Reports Second Quarter 2023 Results; Provides Business Update

Retrieved on: 
Monday, August 14, 2023
GMP, Tissue, Pancreatic cancer, Therapy, TTX, Bank statement, SBIR, Neoplasm, Drug discovery, Clinical trial, Cancer, Pharmacokinetics, Transcoding, RNA, Glioblastoma, White Lion, National Cancer Institute, Protein, Investigational New Drug, PFW, Patient, IRB, Metastasis, FIH, Mortality, Research, Phase, FDA, IND, Dana, Pharmaceutical industry, Vaccine, Cryptocurrency, Video game

BOSTON, Aug. 14, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for the second quarter ended June 30, 2023, and recent business progress.

Key Points: 
  • BOSTON, Aug. 14, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for the second quarter ended June 30, 2023, and recent business progress.
  • Research and development expense was $3.0 million in the second quarter of 2023, compared to $2.6 million in the second quarter of 2022.
  • General and administrative expense was $2.2 million in the second quarter of 2023, compared to $2.1 million in the second quarter of 2022.
  • TransCode expects that its cash of $3.6 million as of June 30, 2023, is sufficient to fund planned operations into September 2023 but not for a full 12 months from the date of its financial statements.