Peritoneal cavity

Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum

Retrieved on: 
Tuesday, February 20, 2024
Research, Medical Devices, Surgery, Clinical Trials, Health Technology, Biotechnology, Radiology, Health, Science, Oncology, Society, Survival, Massachusetts General Hospital, Peritoneum, Hospital, Optical flow, Peritoneal cavity, Surgical oncology, Associate, Patient, Dentistry

The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum.

Key Points: 
  • The ongoing study is utilizing the investigational LUMISIGHT optical imaging drug and accompanying imaging device to distinguish tumor metastases to organs within the peritoneum.
  • “This data advances the potential for image-guided surgery to detect small tumors and metastases to organs in the peritoneal cavity which could provide better outcomes for our patients,” said Dr. Cusack.
  • “Further innovation is desperately needed to improve the benefits of cytoreductive surgery for this invasive and elusive cancer.
  • Everything we do at Lumicell is focused on improving surgical outcomes for patients,” said Howard Hechler, President of Lumicell.

New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload

Retrieved on: 
Tuesday, February 6, 2024
ICU, Diuretic, Mount Sinai Hospital, Patient, Cirrhosis, Ascites, FDA, Peritoneal cavity, Aquapheresis, Literature review, Food, Blood, Paracentesis, Series, Liver disease, Blood volume, Medical imaging

The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .

Key Points: 
  • The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .
  • The most common cause of liver disease was alcohol-related, with nine of the 14 patients presenting with alcohol-associated cirrhosis.
  • In this case series, Aquadex was shown to provide a potential additional solution to mitigate these clinical gaps.
  • Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics.

Ocelot Bio Receives FDA Orphan Drug Designation for OCE-205 for the Treatment of Ascites

Retrieved on: 
Wednesday, December 20, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Peritoneal cavity, Ascites, Food, Cirrhosis, Orphan, Cancer, Abdomen, Patient, Diagnosis, Therapy, ESLD, Hepatorenal syndrome, Pharmaceutical industry

“The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.

Key Points: 
  • “The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.
  • The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.
  • Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.
  • This is the second Orphan Drug Designation for OCE-205, which previously received the designation in hepatorenal syndrome.

OncoNano Medicine Presents Data from Phase 2 Pegsitacianine Study at Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care

Retrieved on: 
Monday, March 27, 2023
Biotechnology, Health, Oncology, Clinical Trials, Surgical oncology, Society, SSO, Breakthrough therapy, Doctor of Philosophy, Peritoneal cavity, Patient, FDA, International Congress on Tuberculosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Medical imaging, Pharmaceutical industry

OncoNano Medicine, Inc. presented data from a Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, at the Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care, occurring March 22-25 in Boston, MA.

Key Points: 
  • OncoNano Medicine, Inc. presented data from a Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, at the Society of Surgical Oncology (SSO) 2023 International Congress on Surgical Cancer Care, occurring March 22-25 in Boston, MA.
  • Data from the study revealed that the primary endpoint was achieved in 50% of the evaluable patients undergoing peritoneal carcinomatosis surgery.
  • The primary objective of this Phase 2 study was to determine if the administration of pegsitacianine (1 mg/kg) prior to surgery results in the detection of additional disease following standard of care surgical resection of peritoneal metastases.
  • “These results show that pegsitacianine can safely be administered up to three days in advance of surgery, without any impact on the planned surgical approach.

Enlivex Receives Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers

Retrieved on: 
Monday, March 20, 2023
Medicine, DSMB, Peritoneum, SOC, Immunotherapy, Ministry, Peritoneal cavity, Data monitoring committee, MD, Patient, Standard of care, Therapy, Safety, Pharmaceutical industry, Vaccine, Health

The Israeli Ministry of Health (IMOH) also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort.

Key Points: 
  • The Israeli Ministry of Health (IMOH) also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort.
  • In addition, the safety profile supported a protocol amendment to start new patients in the second cohort with higher initial doses of Allocetra™.
  • This IMOH clearance follows a previously-reported IMOH clearance to the Company’s second Phase I/II clinical trial, which is evaluating Allocetra™ as monotherapy and in combination with anti-PD1 checkpoint inhibitors in patients with advanced-stage solid tumors.
  • Following the DSMB recommendation, the IMOH reviewed the available safety data for the first cohort and provided regulatory clearance to initiate the recruitment of patients into the second cohort.

Sequana Medical announces the successful completion of pre-clinical studies with its second-generation DSR product for congestive heart failure

Retrieved on: 
Wednesday, February 8, 2023
Sheep, Mouse, Health, Safety, Euronext, DSR, PD, Heart, IND, Icodextrin, Cancer, GLP, Animal, Omentum, 2.0, Peritoneal dialysis, Patient, Overload, FDA, Congestion, Interim, Liver disease, Peritoneal cavity, Peritoneum, CHF, Heart failure, Pharmaceutical industry

These animal data, together with the data from the Phase 1 CHIHUAHUA study, are intended to support the US IND filing of DSR 2.0.

Key Points: 
  • These animal data, together with the data from the Phase 1 CHIHUAHUA study, are intended to support the US IND filing of DSR 2.0.
  • The GLP studies were conducted on 30 healthy mice and 18 healthy sheep.
  • Each animal study comprised of three study groups which included one control group using standard peritoneal dialysis (PD) solution and two test groups using Sequana Medical’s proprietary DSR 2.0 product.
  • Oliver Gödje, Chief Medical Officer at Sequana Medical, commented: “We are pleased to see these positive animal data of our second-generation DSR product, which is designed to deliver therapeutic and safety benefits over the first-generation DSR product.

OncoNano Medicine’s Pegsitacianine Granted Breakthrough Therapy Designation for Real-Time Surgical Imaging by the Food and Drug Administration

Retrieved on: 
Wednesday, January 4, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Breakthrough therapy, Patient, Ovarian cancer, Surgeon, Peritoneal cavity, Neoplasm, Food, Safety, Metastasis, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medical imaging

OncoNano Medicine, Inc. today announced that its lead clinical development candidate, pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, has received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.

Key Points: 
  • OncoNano Medicine, Inc. today announced that its lead clinical development candidate, pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, has received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
  • “We are thrilled to receive breakthrough therapy designation, which underscores the potential of pegsitacianine to alter the paradigm of surgical imaging in oncology,” said Kartik Krishnan, Chief Medical Officer of OncoNano.
  • A Breakthrough Therapy Designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.
  • Based on the results of an ongoing Phase 2 clinical trial evaluating the safety and efficacy of pegsitacianine following standard of care cytoreductive surgery, pegsitacianine enabled surgeons to detect additional cancerous tissue at a clinically significant rate of >50%.

Ocelot Bio Presents Phase 1 Data Highlighting Activity and Safety of OCE-205 at AASLD The Liver Meeting®

Retrieved on: 
Friday, November 4, 2022
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, Overload, Food, Portal hypertension, Liver, Șaeș, Publication, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Extrapyramidal system, Interest group, FDA, Ocelot, Hepatorenal syndrome, AES, Digital, Venrock, American Association for the Study of Liver Diseases, Poster, Vasoconstriction, AUC, Institute of Liver and Biliary Sciences, AASLD, Acute kidney injury, Nature, Ascites, Safety, Novel, Liver disease, Peritoneal cavity, Fatty liver disease, Bio, Ischemia, DVM, SIG, Cirrhosis, ESLD, Association, Patient, American Association, Pharmaceutical industry, Fine chemical, Cmax, Tolerability

Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.

Key Points: 
  • Across the dose range studied, OCE-205 serum levels (AUC and Cmax) were dose proportional.
  • The Phase 1 data presented at AASLD provide valuable information that will inform our clinical development strategy for OCE-205.
  • These data support further clinical development of OCE-205 as a potential treatment for conditions such as HRS-AKI and ascites.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

PharmaCyte Biotech Board of Directors Announces Business Review Committee to Evaluate Opportunities to Optimize Shareholder Value

Retrieved on: 
Friday, October 7, 2022
U.S. Securities and Exchange Commission, Pancreatic cancer, Assistant, Review, IND, The Co Founder, Neoplasm, Ascites, Lehigh University, LLC, Â, Regulation of tobacco by the U.S. Food and Drug Administration, Cell, Diabetes, Board of directors, Immortalised cell line, Nasdaq, Cancer, Technology, Private Securities Litigation Reform Act, Form 10-K, Food, Company, Share repurchase, Board, CEO, Form, Liver, Ifosfamide, GLOBE, Peritoneal cavity, Insulin, Austria, PMCB, FDA, Capsule, Principal, Management, Pharmaceutical industry, Security (finance), Medical imaging

The Board has since appointed Joshua N. Silverman, a member of the Board, as interim CEO.

Key Points: 
  • The Board has since appointed Joshua N. Silverman, a member of the Board, as interim CEO.
  • Mr. Silverman commented, On behalf of the Board and PharmaCyte shareholders, Id like to wish Ken all the best in his future endeavors.
  • As disclosed in our most recently filed 10-Q, our newly reconstituted Board of Directors has formed a Business Review Committee to evaluate, investigate and review PharmaCytes strategy and operations, as well as the risks relative to our business.
  • Until the review by the Business Review Committee and the Board is complete and the Board has determined the actions and plans to be implemented, the Board has curtailed spending on the foregoing programs.

Celsion Completes Enrollment of the Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

Retrieved on: 
Thursday, September 15, 2022
Paclitaxel, Time, Safety, Carboplatin, IV, Woman, Malignancy, Risk, FDA, DSMB, IL-12, Ovarian cancer, Neoplasm, Severe acute respiratory syndrome coronavirus 2, Data monitoring committee, Company, Surface epithelial-stromal tumor, Private Securities Litigation Reform Act, Immunity, Immunotherapy, Patient, Cancer, U.S. Securities and Exchange Commission, III, EOC, Progression-free survival, Toxic leukoencephalopathy, CRS, Diagnosis, NASDAQ, Peritoneal cavity, RNA, Research, DNA, GLOBE, Recurrence, Pharmaceutical industry, Vaccine

LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the second half of 2023.

Key Points: 
  • LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation(NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients.
  • The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer.
  • There are approximately 22,000 new cases of ovarian cancer every year and the majority (approximately 70%) are diagnosed in advanced stages III and IV.