Month: June 2023

AISA Pharma Announces Start of Phase 2b Profervia® Study for Raynaud’s Phenomenon in Systemic Sclerosis (SSc)


Phase 2 Data at EULAR Suggested Profervia® Treatment Might Influence Systemic Sclerosis (SSc) Disease Severity Excerpt from the Press Release: BOSTON, June 21, 2023 /PRNewswire/ — Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company today announced initiation of Part 2 of the RECONNOITER Phase 2 study, evaluating Profervia®, a once-daily novel, oral calcium-channel antagonist (CCB) in patients with SSc…

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Oncolytics Biotech’s® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial


Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic…

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Epic Bio Presents Compelling Preclinical Data Supporting Clinical Initiation of EPI-321 for FSHD


– NHP studies demonstrate EPI-321’s favorable safety and pharmacokinetic profile – – IND and CTA applications planned for 2023 – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., June 16, 2023 (GLOBE NEWSWIRE) — Epic Bio, a biotechnology company developing therapies to modulate gene expression using compact, non-cutting dCas proteins, today presented new non-human…

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Pulmatrix Presents PUR3100 Phase 1 Data at the 65th Annual Meeting of the American Headache Society


Excerpt from the Press Release: LEXINGTON, Mass., June 15, 2023 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology, today announced it will present data at the American Headache Society 65th Annual Meeting, being held from June…

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Simplified Trial Management With Integrated Randomization / IWRS Functionality


TrialStat EDC provides integrated IWRS functionality, allowing for any degree of randomization complexity. Tied into screening (inclusion / exclusion criteria) as well as with pain scores or other qualifying metrics to randomize patients into cohorts. Using TrialStat IWRS will enable sites to trigger randomization codes directly without leaving TrialStat EDC, and without the need or…

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Allogene Therapeutics Provides Additional ALLO-501/501A Phase 1 Data in an Oral Presentation at the International Conference on Malignant Lymphoma (ICML) Lugano


Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., June 15, 2023 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland presented updated data from the Phase 1…

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Verge Genomics Announces Positive Safety and Tolerability Data from the Phase 1 Clinical Trial of VRG50635, a Potential Best-in-Class Therapeutic for All Forms of ALS


Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Verge Genomics, a clinical-stage biotechnology company transforming drug discovery using artificial intelligence and human data, today announced the completion of the Phase 1 clinical trial of VRG50635 in healthy adult volunteers. VRG50635 was dosed up to the maximum single and repeated doses planned, demonstrating a favorable…

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Anokion Announces Publication in The Lancet Gastroenterology & Hepatology Highlighting Safety and Preliminary Effects of KAN-101 in Celiac Disease in its ACeD Phase 1 Clinical Trial


KAN-101 represents the first agent to modulate the IL-2 biomarker associated with symptomatic responses to gluten exposure in celiac patients KAN-101 advancing in a Phase 1b/2 clinical trial in celiac disease and immune tolerance Excerpt from the Press Release: CAMBRIDGE, Mass. & LAUSANNE, Switzerland–(BUSINESS WIRE)–Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease…

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4DMT Presents Positive Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial in Patients with Cystic Fibrosis at the ECFS 46th Annual Meeting


Excerpt from the Press Release: EMERYVILLE, Calif., June 07, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic…

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Gritstone bio Announces Publication of Interim Results from Phase 1 Study of Self-amplifying mRNA (samRNA) Vaccine Against COVID-19 in Nature Communications


— Potent and durable immunogenicity achieved with low dose self-amplifying mRNA vaccine (samRNA) candidate — — Immunity boosted for at least 6 months in previously vaccinated-older adults (administration post-primary series of Vaxzevria®, Comirnaty® or Spikevax®) — — Data underscore the potential of Gritstone’s samRNA candidates to serve as next-generation vaccines against COVID-19 and other infectious…

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