NANOLOGY


Associated tags: Toxicity, Neoplasm, Taxane, Research, Biotechnology, Pharmaceutical, Clinical Trials, Oncology, Health, FDA, Pharmaceutical industry, Medical imaging, LSAM, Patient, Safety, Pancreas, Lung, U.S. FDA, Science, MD, Clinical trial

Locations: TEXAS, UNITED STATES, NORTH AMERICA, CHICAGO, EUROPE, CHINA, AUSTRALIA, INDONESIA, RUSSIA, JAPAN, US, CANADA

NanOlogy Clinical and Preclinical Immune Data Presented at NACLC and SITC

Retrieved on: 
Tuesday, December 19, 2023

NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.

Key Points: 
  • NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.
  • The poster was authored by clinical investigators Hiren Mehta , Abhishek Biswas , Sarah Wang , Jason Akulian , Christine Argento , et.al.
  • Summarizing presented data:
    The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies, including systemic immunotherapy.
  • Summarizing presented data:
    Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX, including changes in T cells and MDSCs.

Interim Results from a NanOlogy Phase 2 Clinical Trial of its Intratumoral Investigational Drug in the Treatment of Locally Advanced Pancreatic Cancer

Retrieved on: 
Tuesday, October 10, 2023

The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts.

Key Points: 
  • The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts.
  • “Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%,” said lead investigator and author, Neil Sharma, MD.
  • The research article reports data from evaluable subjects in the first two cohorts while the third is pending final readout.
  • Additionally, two posters presented downstaging and immune data from the Phase 2 trial following IT LSAM-PTX at the recent AACR Special Conference on Pancreatic Cancer.

NanOlogy Presents Clinical Research at 2023 DDW and ASCO Involving its Large Surface Area Microparticle Investigational Drugs

Retrieved on: 
Wednesday, June 7, 2023

NanOlogy LLC , a clinical-stage oncology company, announces a presentation of clinical research involving its large surface area microparticle (LSAM) investigational drugs at DDW 2023 in May and publication at ASCO Annual Meeting in June.

Key Points: 
  • NanOlogy LLC , a clinical-stage oncology company, announces a presentation of clinical research involving its large surface area microparticle (LSAM) investigational drugs at DDW 2023 in May and publication at ASCO Annual Meeting in June.
  • The DDW poster entitled “Intracystic Injection of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) for Chemoablation of Intraductal Papillary Mucinous Neoplasms: Insights from an Expanded Access Protocol,” was presented by the research team of Somashekar Krishna, MD of The Ohio State University Wexner Medical Center.
  • The expanded access protocol prospectively evaluated safety and response of six subjects from the trial who received additional doses of LSAM-PTX.
  • “In this protocol, intracystic LSAM-PTX was safe and resulted in cyst volume and surface area reduction, morphological changes, and loss of pathogenic mutations,” said Dr. Krishna.

NanOlogy Granted a US Patent for Its Investigational Drugs in Combination with Immune Checkpoint Inhibitors in the Treatment of Cancer

Retrieved on: 
Tuesday, March 7, 2023

The patent ( 11,583,499 ) is valid in the US until November 25, 2038, and has corresponding filings globally.

Key Points: 
  • The patent ( 11,583,499 ) is valid in the US until November 25, 2038, and has corresponding filings globally.
  • ICIs are often used in combination with other systemic cancer therapies particularly in the treatment of solid tumors to prime the immune system to increase response.
  • “The Cancer Research Institute estimates more than 5000 clinical trials are underway worldwide with immune checkpoint inhibitors; many are combination trials with other systemic cancer agents in solid tumors.” said Gere DiZerega, MD, NanOlogy Chief Medical Officer.
  • “The goal is to identify which combinations can increase the immune response thereby increasing the overall solid tumor response to treatment.

NanOlogy Publishes Results From a Clinical Trial of Intracystic LSAM-PTX in Mucinous Pancreatic Cysts

Retrieved on: 
Tuesday, December 20, 2022

Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer.

Key Points: 
  • Certain mucinous pancreatic cysts are at high risk for progression to pancreatic cancer.
  • Results from the trial are intended to support future research in this patient subset to evaluate whether intracystic LSAM-PTX can decrease the rate of progression.
  • The treatment is covered by a recently issued US patent ( 11,523,983 ) entitled Treatment of Epithelial Cysts by Intracystic Injection of Antineoplastic Particles.
  • Enrollment is also complete (n=54) in a NanOlogy-sponsored clinical trial of intratumoral (IT) LSAM-PTX with systemic chemotherapy in locally advanced pancreatic cancer (LAPC).

NanOlogy Completes Enrollment in Phase 2a Trial of Intratumoral LSAM-PTX with SOC in Patients with Nonoperable Lung Cancer

Retrieved on: 
Friday, November 11, 2022

NanOlogy LLC , a clinical-stage interventional oncology drug company, announced enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer.

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced enrollment is complete in a Phase 2a trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) with standard of care (SOC) therapy in patients with nonoperable lung cancer.
  • The primary outcome measure for the trial is safety, as determined by treatment emergent adverse events.
  • Lung cancer has the highest mortality of any cancer with 2.2 million new cases and 1.8 million deaths estimated globally in 2020 by GLOBOCAN .
  • ICIs are rapidly becoming a SOC for the treatment of lung cancer often combined with other agents to increase response.

NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

Retrieved on: 
Monday, October 3, 2022

NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel (LSAM-DTX), has been published in Drug Delivery and Translational Research (DDTR) .

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel (LSAM-DTX), has been published in Drug Delivery and Translational Research (DDTR) .
  • The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel (LSAM-PTX), published in DDTR in 2020.
  • LSAMDTX in combination with an immune checkpoint inhibitor demonstrated synergy in a preclinical metastatic breast cancer model.
  • In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers.

NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of Large Surface Area Microparticle Docetaxel in High-Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Monday, August 1, 2022

NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of Large Surface Area Microparticle Docetaxel (LSAM-DTX) in High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) have been published in The Journal of Urology .

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of Large Surface Area Microparticle Docetaxel (LSAM-DTX) in High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) have been published in The Journal of Urology .
  • The research article entitled Phase 1/2 Trial Results of a Large Surface Area Microparticle Docetaxel for the Treatment of High-Risk Non-Muscle Invasive Bladder Cancer presents safety and response data from the multi-site study ( NCT03636256 ).
  • Worldwide, an estimated 573,000 people were diagnosed with bladder cancer in 2020 and 81,000 people will be diagnosed with bladder cancer in the United States in 2022.
  • In this Phase 1/2 clinical trial, LSAM-DTX showed promising signs of preventing disease progression and interesting immunogenic effects with minimal adverse events.

NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of its Topical Investigational Drug in the Treatment of Cutaneous Metastases of Breast Cancer

Retrieved on: 
Tuesday, May 3, 2022

NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMBOC) have been published in Breast Cancer Research and Treatment .

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMBOC) have been published in Breast Cancer Research and Treatment .
  • The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study ( NCT03101358 ).
  • SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial.
  • In addition to SOR0007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

Improved Resection Rates in Locally Advanced Pancreatic Cancer Following Addition of Intratumoral NanoPac® to Standard of Care

Retrieved on: 
Tuesday, November 9, 2021

NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today a single-site analysis of data from an ongoing Phase 2a clinical trial ( NCT03077685 ) of intratumoral (IT) NanoPac (large surface area microparticle [LSAM] paclitaxel) suspension showed improved resection rates in locally advanced pancreatic cancer (LAPC).

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today a single-site analysis of data from an ongoing Phase 2a clinical trial ( NCT03077685 ) of intratumoral (IT) NanoPac (large surface area microparticle [LSAM] paclitaxel) suspension showed improved resection rates in locally advanced pancreatic cancer (LAPC).
  • The presentation entitled Improved Resection Rates in Locally Advanced Pancreatic Cancer Following EUS-FNI of Large Surface Area Microparticle Paclitaxel described results from a single clinical site analysis of a subset of nonsurgical patients (n=13) treated with two monthly administrations of IT NanoPac via endoscopic ultrasound guided fine needle injection (EUS-FNI) together with neoadjuvant standard of care.
  • 7/13 (54%) of subjects considered nonsurgical at enrollment were restaged to surgical after addition of IT NanoPac to neoadjuvant standard of care (SOC) therapy.
  • The American Cancer Society estimates nearly 58,000 new cases of pancreatic cancer in the United States for 2021 with more than 47,000 deaths.