August’s top news stories

31st August 2018 (Last Updated August 31st, 2018 00:00)

Gradalis started a Phase lll clinical trial of Vigil in combination with irinotecan and temozolomide for the treatment of patients with Ewing’s sarcoma, and Impel NeuroPharma dosed the first subject in the Phase l Safety and Tolerability of Intranasal POD-olanzapine (SNAP 101) trial of INP105. Drugdevelopment-technology.com wraps up the key news stories from August 2018.

Gradalis commenced Phase lll trial of Vigil in Ewing’s sarcoma

Gradalis started a Phase lll clinical trial of Vigil in combination with irinotecan and temozolomide for the treatment of patients with Ewing’s sarcoma (EWS).

The multicentre, randomised, open-label trial intends to analyse the study drug combination as a second-line regimen for EWS, a rare form of paediatric cancer that originates in bone or soft tissue.

Caused by genetic mutation, EWS is currently estimated to affect around 1,000 individuals across the globe every year.


Impel dosed first subject in Phase l trial of INP105

Impel NeuroPharma dosed the first subject in the Phase l Safety and Tolerability of Intranasal POD-olanzapine (SNAP 101) trial of INP105 for the treatment of acute agitation in bipolar I disorder and schizophrenia.

The randomised, double-blind, placebo-and-active controlled crossover trial is designed to evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) of INP105 in 36 healthy subjects.

During the study, three ascending doses of INP105 will be delivered to compare them with two doses of Zyprexa intramuscular and orally disintegrating Zyprexa Zydis.


UC San Diego School of Medicine started Phase Ib breast cancer trial

A team of researchers at the University of California (UC) San Diego School of Medicine initiated a Phase Ib clinical trial to evaluate the safety and tolerability of cirmtuzumab and standard chemotherapy combination for the treatment of metastatic or locally advanced breast cancer.

The trial will enrol up to 15 patients whose cancer cannot be removed surgically in order to administer the combination therapy for a period of six months.

For the trial, the researchers will combine cirmtuzumab with paclitaxel (Taxol), a chemotherapy medication originally derived from the Pacific yew tree and has been proved to be effective in various types of cancer treatments.


MGC Pharmaceuticals received approval for Phase II trial of CogniCann

MGC Pharmaceuticals (MXC) received approval from the University of Notre Dame in Western Australia’s (UNDA) Human Research Ethics Committee (HREC) to carry out a Phase II clinical trial to examine the effects of CogniCann for the treatment of patients with mild dementia and Alzheimer’s disease.

The approval was granted following the completion of an ethical review by HREC, in line with Australia’s National Statement on Ethical Conduct in Human Research rules.

Subject to Australia’s Therapeutic Goods Administration (TGA) approval, the 16-week, randomised, double-blind, crossover, placebo-control trial is expected to start early next year.


AstraZeneca reported negative top-line results from AERISTO trial

AstraZeneca reported negative top-line results from the AERISTO trial, a Phase IIIb study of Bevespi Aerosphere (glycopyrronium/formoterol fumarate) against umeclidinium/vilanterol for the treatment of patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The results revealed that Bevespi Aerosphere showed non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1), but did not show improvement on peak FEV1 or non-inferiority on trough FEV1.

The trial, however, showed that the safety and tolerability data of Bevespi Aerosphere were consistent with the known profile of the medicine.


DrugCendR began CEND1-001 trial for pancreatic cancer

DrugCendR started the Phase l CEND1-001 trial to examine the safety, tolerability, and biologic activity of CEND-1 in combination with nabpaclitaxel and gemcitabine to treat patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

The open-label, multicentre, dose-escalation, safety, pharmacodynamic, and pharmacokinetic trial intends to enrol 34 PDAC patients being treated with combination therapy of nabpaclitaxel and gemcitabine.

As part of the trial, the patients will receive the study combination weekly for three weeks followed by one week off over 28 days.


Imago BioSciences completed enrolment in Phase l/lla trial of IMG-7289

Imago BioSciences completed patient enrolment in a Phase I/IIa clinical trial of IMG-7289 for the treatment of high-risk acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS).

A total of 45 patients have been enrolled in the trial, which aims to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-neoplastic activity of IMG-7289.

The trial already completed its Phase I multiple-ascending dose portion to analyse IMG-7289 as a single agent and has moved towards the Phase IIa expansion arm.


Inovio dosed first patient in Phase l/lla of INO-5401 and atezolizumab

Inovio Pharmaceuticals dosed its first patient in a Phase l/lla trial to analyse the safety, immunogenicity and clinical efficacy of INO-5401 plus INO-9012 in combination with atezolizumab for the treatment of advanced or metastatic bladder cancer.

The non-randomised, open-label, multi-centre trial is expected to enrol 85 patients who have been divided into two cohorts.

Cohort A comprises patients with confirmed disease progression during or following prior checkpoint inhibitor therapy, while Cohort B includes patients who are treatment naïve and unfit for cisplatin-based therapy.


Rafael activated new site for Phase I of CPI-613 and bendamustine

Rafael Pharmaceuticals activated the second clinical trial site for its Phase I trial of CPI-613 in combination with bendamustine to treat patients with relapsed or refractory T-Cell Lymphoma at the University of Pennsylvania’s Abramson Cancer Center in the US.

The trial is currently being conducted at the Comprehensive Cancer Center at Wake Forest Baptist Medical Center in North Carolina, US.

Its primary objective is to determine the maximum tolerated dose (MTD) of CPI-613 when used in combination with bendamustine, for the treatment of patients with relapsed or refractory T-Cell Lymphoma, or classic Hodgkin Lymphoma.


Kyowa Kirin reported positive results from MAVORIC study

Japan-based Kyowa Hakko Kirin reported positive results from the Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL (MAVORIC) study after meeting its primary endpoint.

MAVORIC is a Phase lll trial that examined mogamulizumab in comparison with vorinostat for the treatment of patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS), both of which are the most common subtypes of cutaneous T-cell lymphoma (CTCL).

The pivotal, open-label, randomised, multi-centre trial included 372 adult patients after at least one prior systemic therapy across 61 sites in 11 countries.