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
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Retrieved on:
Tuesday, December 19, 2023
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Vaccine 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.
Retrieved on:
Tuesday, October 10, 2023
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Safety 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.
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MD 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.
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Cancer 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.
Retrieved on:
Tuesday, December 20, 2022
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Pharmaceutical industry 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).
Retrieved on:
Friday, November 11, 2022
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LLC 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.
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Biotechnology 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.
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MD 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.
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MD 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.
Retrieved on:
Tuesday, November 9, 2021
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Medical imaging 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.