Palifermin | Jotup

Aimmune’s PALISADE-ARC004 Longitudinal Study Showed PALFORZIA® Safety and Efficacy Increased Over Time in Patients with Peanut Allergy

Retrieved on:

Wednesday, August 4, 2021

The manuscript, titled Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy, was published online.

Key Points:

The manuscript, titled Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy, was published online.
Patients who completed the PALISADE trial were eligible to enter the ARC004 open-label follow-on study, which evaluated the long-term efficacy and safety of daily PALFORZIA dosing beyond one year (52 weeks).
After two years of daily PALFORZIA treatment, 80.8% of study participants tolerated 2000 mg of peanut protein in the double-blind, placebo-controlled food challenge.
PALISADE (Peanut Allergy oral Immunotherapy Study of AR101 for Desensitization) was an international, randomized (3:1), double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of AR101 in patients with peanut allergy.

Prometheus Biosciences Announces Initiation of APOLLO-CD Phase 2a Clinical Trial of PRA023 in Moderate-to-Severe Crohn’s Disease

Retrieved on:

Monday, August 2, 2021

Receptor antagonists, Pyrimidines, Draft:PPP001, Palifermin

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the initiation of the APOLLO-CD Phase 2a clinical trial evaluating PRA023 for moderate-to-severe Crohn’s disease (CD), with first patient enrollment.

Key Points:

We believe PRA023 has the potential to address the highest unmet need of fibrostenotic disease in this patient population.
The APOLLO-CD Phase 2a trial is an open-label study designed to evaluate the proof-of-concept efficacy and safety of PRA023 in moderate-to-severe Crohns disease with centrally read endoscopy as the primary endpoint.
Prometheus has recently completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled trial to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers.
Safety and tolerability observed to date supports the initiation of this Phase 2a trial.

Dicerna Initiates Patient Dosing in ESTRELLA Phase 2 Clinical Trial of Belcesiran for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Retrieved on:

Tuesday, June 22, 2021

We are very pleased to have now begun patient dosing in our Phase 2 ESTRELLA trial to better understand belcesirans potential to treat the underlying cause of AATLD.

Key Points:

We are very pleased to have now begun patient dosing in our Phase 2 ESTRELLA trial to better understand belcesirans potential to treat the underlying cause of AATLD.
ESTRELLA ( NCT04764448 ) is a randomized, multidose, double-blind, placebo-controlled Phase 2 trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of belcesiran in participants with AATLD.
The ESTRELLA clinical trial is part of Dicernas SHINE clinical development program to evaluate the safety and efficacy of belcesiran, formerly known as DCR-A1AT, for the treatment of AATLD.
A Phase 1 trial of multiple doses of belcesiran in healthy volunteers is ongoing, with initial data from the Phase 1 trial expected in mid-2021.

Synlogic Presents Data Demonstrating Activity of a Solid Oral Formulation of SYNB1618 at American College of Medical Genetics (ACMG) Annual Meeting

Retrieved on:

Tuesday, April 13, 2021

Palifermin

A solid oral lyophilized powder formulation was evaluated in a Phase 1 study in healthy volunteers.

Key Points:

A solid oral lyophilized powder formulation was evaluated in a Phase 1 study in healthy volunteers.
In this study, the safety, tolerability and pharmacodynamics of multiple doses of SYNB1618 were assessed.
A solid oral lyophilized formulation of SYNB1618 was found to be safe and well-tolerated, and consumes Phe in the GI tract of healthy volunteers.
These forward-looking statements should not be relied upon as representing Synlogic\'s view as of any date subsequent to the date hereof.\n'

Pinteon Therapeutics Announces First Patient Dosed in Phase 1 Study of PNT001 in Patients with Acute Traumatic Brain Injury

Retrieved on:

Tuesday, April 6, 2021

Biotechnology, Pharmaceutical, Health, Clinical trials, Treatment of Alzheimer's disease, Clinical trials, Monoclonal antibodies, Palifermin, Bapineuzumab

Based on preclinical and human data, as well as promising safety results from our study of PNT001 in healthy volunteers, we believe our investigational therapy has the potential to block the spread of neurotoxic tau observed in traumatic brain injury.

Key Points:

Based on preclinical and human data, as well as promising safety results from our study of PNT001 in healthy volunteers, we believe our investigational therapy has the potential to block the spread of neurotoxic tau observed in traumatic brain injury.
The randomized, double-blind, placebo-controlled multiple ascending dose study will enroll 64 patients across two dose level cohorts that, based on the Phase 1 study in healthy volunteers, will provide potentially therapeutic cerebrospinal fluid concentrations of PNT001.
Patients will be randomized to receive three monthly intravenous doses of PNT001 or placebo, and will receive their first dose within 24 hours of documented traumatic brain injury.
Pinteon Therapeutics is advancing clinical studies of a novel antibody that aims to interrupt the spread of toxic tau and protect and preserve brain function in patients with neurodegenerative disease.

Revance to Showcase Phase 3 Results Evaluating DaxibotulinumtoxinA for Injection for the Treatment of Cervical Dystonia at the American Academy of Neurology Annual 2021 Virtual Meeting

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Thursday, April 1, 2021

Biotechnology, Pharmaceutical, Health, Clinical trials, Health sciences, Clinical research, Design of experiments, Health, Medical research, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Lanadelumab, Palifermin, Cervical Dystonia, Revance Therapeutics, Inc.

Revance will present results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults.

Key Points:

Revance will present results from its ASPEN-1 Phase 3 clinical trial evaluating the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults.
Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo.
Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period.
Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection.

HUTCHMED Initiates International Phase I Trials of IDH1/2 Dual Inhibitor in Patients with Advanced Solid Tumors or Hematological Malignancies

Retrieved on:

Monday, March 29, 2021

Monoclonal antibodies, Drugs, Clinical medicine, Milatuzumab, Palifermin

One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies.

Key Points:

One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies.
The first international patient was dosed on March 25, 2021, following a Phase I trial that was initiated in China in the second half of 2020.
These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306.
The second stage is a dose expansion phase where patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity at the RP2D.

Revelation Biosciences Inc. Completes Dosing of Five Single Dose Cohorts and Receives Approval to Initiate a Multiple Dose Cohort to Phase 1 Clinical Study of REVTx-99, an Experimental Treatment for Respiratory Viral Infection, Including COVID-19

Retrieved on:

Wednesday, February 3, 2021

REVTx-99 is in development for the treatment and prevention of respiratory viral infection, including SARS-CoV-2 Infection (COVID-19).

Key Points:

REVTx-99 is in development for the treatment and prevention of respiratory viral infection, including SARS-CoV-2 Infection (COVID-19).
RVL-NHV01 is a single site, placebo-controlled, single dose, escalating dose, followed by multiple dose arm to determine the safety and tolerability of intranasal REVTx-99 in healthy adult volunteers.
The Phase 1 study single dose escalation portion of the study was completed in January 2021, in which 40 study participants were dosed with REVTx-99 (n=6) or placebo (n=2).
Revelation plans to initiate a Phase 1/2 study during the first half of 2021 in early stage COVID-19 patients at risk for hospitalization.

Selva Therapeutics Announces Successful Completion of Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

Retrieved on:

Tuesday, February 2, 2021

Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19.

Key Points:

Selva Therapeutics, Inc. today announced that the Phase 1 clinical study met its primary objective of demonstrating safety and tolerability of SLV213, a potential oral treatment for COVID-19.
The company plans to rapidly advance SLV213 into a Phase 2 study in non-hospitalized COVID-19 patients.
The Phase 1 study was a randomized, placebo-controlled, double-blinded study conducted in healthy volunteers.
We successfully completed our Phase 1 study with no dose-limiting toxicity, said Ken Krantz M.D., Ph.D., Chief Medical Officer of Selva Therapeutics.

Arch Biopartners Receives Ethics Committee Approval in Turkey to Dose Additional Patients in the Phase II Trial for LSALT Peptide

Retrieved on:

Tuesday, February 2, 2021

Clinical research, Design of experiments, Medical research, Health sciences, Chemical compounds, Placebo-controlled study, Randomized controlled trial, Palifermin, Clinical trial

Clinical sites in Istanbul and Ankara originally were approved to dose twenty patients who have since been successfully randomized into the double blind, placebo-controlled trial.

Key Points:

Clinical sites in Istanbul and Ankara originally were approved to dose twenty patients who have since been successfully randomized into the double blind, placebo-controlled trial.
The Ethics Committee approval will be followed by a regulatory review conducted by the Turkish Ministry of Health (MoH) before the additional patients can be randomized into the trial.
To date, there have been approximately 20 patients dosed in North America in addition to the 20 patients dosed in Turkey.
Additional information about the Phase II trial can be found at:
The Phase II results will be used to design the Phase III program, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients.