imatinib (AER-901) / Aerami Therap, Molex, Chance Pharma - LARVOL DELTA

uniPHied: A Novel Platform Study Design for a Phase 2 Clinical Trial to Assess the Safety and Efficacy of AER-901 in Pulmonary Hypertension Associated With Interstitial Lung Disease and Pulmonary Arterial Hypertension (ATS 2024) - "The unique platform design of uniPHied allows for expeditious evaluation of AER-901 in multiple pulmonary hypertension cohorts (PH-ILD and PAH) using smaller patient numbers. Each cohort is individually powered for the primary endpoint, allowing addition of cohorts for expansion to other pulmonary hypertension groups."

Clinical • P2 data • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Rare Diseases • Respiratory Diseases

Functional Respiratory Imaging and Rapid Deposition Analysis Predict Enhanced Lung Deposition of Imatinib With the AER-901 Inhalation System in Pulmonary Hypertension (ATS 2024) - "At equivalent nominal doses, FRI/RDA demonstrated enhanced deposition of imatinib throughout all regions of the lung for AER-901 compared with DPI-imatinib, suggesting that the AER-901 Inhalation System is more efficient than a DPI at delivering imatinib. These findings were consistent across all populations evaluated."

Cardiovascular • Gastrointestinal Disorder • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

LOW SYSTEMIC EXPOSURE AND MINIMAL ACCUMULATION PREDICTED WITH TWICE-DAILY ADMINISTRATION OF AER-901 (INHALED IMATINIB) AT POTENTIAL THERAPEUTIC DOSES (CHEST 2023) - P1 | "AER-901 20 mg BID was estimated to achieve trough levels within an effective range, was associated with low systemic exposure compared with PO imatinib, and was predicted to have limited plasma accumulation. CLINICAL IMPLICATIONS: A BID dosing strategy may provide patients with optimized trough levels to support efficacy while limiting the incidence of AEs."

Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Low Systemic Exposure With Targeted Administration of AER-901 (Inhaled Imatinib): Results of a Phase 1 Clinical Trial (ERS 2023) - P1 | "Targeted administration of AER-901 to the lung was generally well tolerated and associated with low systemic imatinib exposures. Evaluation of AER-901 in patients with pulmonary hypertension in phase 2 is warranted.; Epidemiology; Cell and molecular biology; Imaging"

Clinical • P1 data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Projected Savings for Generic Oncology Drugs Purchased via Mark Cuban Cost Plus Drug Company Versus in Medicare, Journal Club - Rashid Sayyid & Zachary Klaassen (Urotoday) - "...and Zach Klaassen explore a study by Brian Cortese and...regarding potential savings through generic oncology drugs purchased via Mark Cuban's Cost Plus Drug Company (MCCPDC) compared to Medicare. The study focuses on the economic impacts of high-priced generic oncology drugs, the financial toxicity experienced by patients, and how MCCPDC can help mitigate these problems."

Video

Pharmacokinetic Profile of Imatinib Mesylate Formulation (AER-901) Demonstrates Potential for Therapeutic Exposure Levels at Low Doses After Pulmonary Administration (ATS 2023) - "The pharmacokinetic profile of AER-901 in rats demonstrated nearly 10-fold higher lung exposure compared with the same oral dose, suggesting that in the clinic, lower doses of the inhaled formulation of imatinib may achieve sufficient exposure in the lung. AER-901 is currently being evaluated in a phase 1 clinical study at inhaled doses approximately 5- to 80-fold lower than the oral imatinib doses investigated in the IMPRES trial."

PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Rapid Advances Shake Up Treatment Considerations in ALL, CML, AML (OncLive) - "...Harry Paul Erba, MD, PhD...discuss key updates pertaining to the leukemia treatment landscape that were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition."

Media quote

Educated Patient Webinar: An Insightful Look at Advanced GIST and Available Treatment Options (Cure Today) - "So I'd have to give a shout out to George Demetri he was on that website. And he's the first one then informed me that that I didn't have my own bias or comment I had GIST and it had a KIT driver. I mean, he told a whole group of just patients online that in 1998, so it was very exciting time, but you don't learn everything in a day...Dr. Mark Agulnik So currently, there are several FDA approved treatments for all patients with GIST so the majority of our GIST patients will first experience the use of imatinib, which is the first drug that is approved for most patients with GIST."

Media quote • Regulatory

Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - P1 | N=83 | Completed | Sponsor: Aerami Therapeutics | Recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Aerami Therapeutics | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

My Thoughts on Managing Patients With CML and Comorbidities (Clinical Care Options) - "In this commentary, I provide a background for comorbidities in chronic myeloid leukemia (CML) and discuss workup, treatment selection, and drug - drug interaction considerations in this patient population."

Online posting

Indispensable for CML Treatment: Imatinib In Which Dose In Which Period? (THD-NHC 2021) - No abstract available.

Shifting the Treatment Paradigm of Severe Asthma With Novel Biologics - Episode 10: Future of Asthma Treatment (HCPLive) - "Reynold Panettieri Jr, MD...There are ongoing trials for PrecISE, which is the severe asthma network funded by NHLBI [National Heart, Lung, and Blood Institute]. But right now, in this space, what are we using? We're using macrolides on Monday, Wednesday, and Friday as an adjuvant. It's not used as an anti-infective but as a potential anti-neutrophil drug."

Video • Asthma