Clinical trial Archives

News and Trends 9 Feb 2023

First toxic shock syndrome vaccine phase 2 study completed

The first vaccine to potentially prevent Staphylococcal-induced toxic shock syndrome (TSS) has successfully completed a phase 2 study. TSS is a life-threatening condition caused by toxins that can lead to multiple organ failure and death. Nosocomial pathogen methicillin-resistant Staphylococcus aureus (MRSA) bacteria are resistant to widely-used antibiotics. Infections with MRSA are harder to treat and […]

February 9, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 9 Feb 2023

Cleveland Clinic breast cancer vaccine study moves forward

Researchers from global health system Cleveland Clinic have launched the next step in their novel study of a vaccine aimed at preventing triple-negative breast cancer, the most aggressive and lethal form of the disease. Funded by the U.S. Department of Defense, the new phase 1b study will enroll cancer-free individuals at high risk for developing […]

February 9, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 7 Feb 2023

Certa scleroderma study shows improvement in more than 60% of patients

Certa Therapeutics has announced what it says are ground-breaking clinical trial data for FT011, its novel therapy for the treatment of serious inflammatory and fibrotic diseases. Certa Therapeutics has recently completed a global phase 2, multi-centre, randomized, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in patients with scleroderma. […]

February 7, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 3 Feb 2023

Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug

Genoscience Pharma has announced that its lead candidate, ezurpimtrostat, a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor, has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of hepatocellular carcinoma (HCC). ODD qualifies ezurpimtrostat for a potential seven years of market exclusivity after approval. The FDA’s ODD program provides […]

February 3, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 2 Feb 2023

Almost 20% of cancer trials have recruited only one patient

Phesi Inc., a global provider of clinical development data analytics, has published an analysis of site-level enrolment data from 173 cancer clinical trials conducted in the past three years. The data, spanning 83,916 cancer patients from 57 countries, reveals that of the 11,826 investigator sites participating in these trials, 2,298 (19%) enrolled just one patient […]

February 2, 2023 - 3 minutesmins - By Jim Cornall

In Depth 1 Feb 2023

Expanding the world of biomarkers with proteogenomics

By Michael Pisano, executive vice president, proteomics, Discovery Life Sciences In oncology, characterizing genetic markers is a powerful tool, but it only tells part of the story. A burgeoning field called proteogenomics is helping uncover downstream biomarkers that represent the functional changes resulting from gene expression that will launch research and development of new, targeted […]

February 1, 2023 - 7 minutesmins - By External Contributor

News and Trends 31 Jan 2023

Active Biotech trial confirms eye treatment safety

Active Biotech has announced the completion of the phase I clinical study testing the safety and tolerability of its newly-developed laquinimod eye drop formulation in healthy subjects. According to the results, the eye drop was safe and well tolerated both at single ascending doses and after repeated doses for up to 21 days. No serious […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 31 Jan 2023

BiVictriX announces positive data from leukemia study

BiVictriX Therapeutics plc has announced positive in vivo data from a toxicity evaluation study with BVX001, the company’s lead program, compared to gemtuzumab ozogamicin (GO). GO, marketed as Mylotarg, is the only approved antibody drug conjugate (ADC) indicated for the treatment of acute myeloid leukemia (AML). One of the significant toxicities of GO is the […]

January 31, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Psoriasis drug may help treat type 1 diabetes

A large clinical study is now beginning on an approved drug for treating psoriasis. The drug will be tested on patients who were recently diagnosed with type 1 diabetes. The theory is that the drug could preserve the patient’s remaining insulin production. Many hospitals in Sweden are participating in the project, which is funded by […]

January 27, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

Onxeo to study prostate cancer drug

French biotech company Onxeo S.A. has given an update on the clinical development program of its first-in-class drug candidate AsiDNA. Onxeo has activated its first U.S. clinical study site, Next Oncology San Antonio. This phase 1b/2 multicenter, basket trial intends to assess the safety and preliminary activity of AsiDNA in combination with olaparib in patients […]

January 27, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 27 Jan 2023

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. The clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or J-Pouch) who experience excessive stool frequency. “Excessive stool frequency […]

January 27, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 26 Jan 2023

Orbsen Therapeutics happy with interim diabetic kidney disease study results

Orbsen Therapeutics Limited has announced what it says are encouraging headline interim results from the EU Horizon 2020-funded NEPHSTROM clinical trial for diabetic kidney disease. NEPHSTROM is a randomized, double-blind, placebo-controlled phase 1/2a, trial evaluating the safety, tolerability and preliminary efficacy of an off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell immunotherapy, ORBCEL, in adult study […]

January 26, 2023 - 3 minutesmins - By Jim Cornall

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The twelve hottest biotech companies in the Boston area

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Clinical trial

First toxic shock syndrome vaccine phase 2 study completed

Cleveland Clinic breast cancer vaccine study moves forward

Certa scleroderma study shows improvement in more than 60% of patients

Genoscience Pharma receives orphan drug designation for hepatocellular carcinoma drug

Almost 20% of cancer trials have recruited only one patient

Expanding the world of biomarkers with proteogenomics

Active Biotech trial confirms eye treatment safety

BiVictriX announces positive data from leukemia study

Psoriasis drug may help treat type 1 diabetes

Onxeo to study prostate cancer drug

FDA clearance for ‘revolutionary’ approach to J-Pouch issue

Orbsen Therapeutics happy with interim diabetic kidney disease study results

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