Surface epithelial-stromal tumor

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.

US Gastro-Intestinal Stromal Tumors Market and Competitive Landscape 2022 - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 8, 2022
Oncology, Health, Hospitals, Surgery, Managed Care, General Health, Pharmaceutical, Competitive landscape, Surface epithelial-stromal tumor, Research, Epidemiology, Medical imaging

The "US Gastro-Intestinal Stromal Tumors Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US Gastro-Intestinal Stromal Tumors Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.
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  • Gastro-Intestinal Stromal Tumors pipeline: Find out the products in clinical trials for the treatment of Gastro-Intestinal Stromal Tumors by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
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    View source version on businesswire.com: https://www.businesswire.com/news/home/20220908005967/en/

Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

Retrieved on: 
Tuesday, June 21, 2022
Time, Immunity, NK, RNA, FDA, Gynecologic Oncology Group, Safety, III, Tumor microenvironment, IV, Company, Recurrence, U.S. Securities and Exchange Commission, Cancer, Research, Private Securities Litigation Reform Act, EOC, Work, DSMB, Cell proliferation, Progression-free survival, DNA, Interim, GLOBE, Surface epithelial-stromal tumor, NASDAQ, Fast track (FDA), Phase, Ovarian cancer, Paclitaxel, Peritoneal cavity, Partnership, Data monitoring committee, CRS, Carboplatin, Patient, Toxic leukoencephalopathy, Neoplasm, Diagnosis, PFS, Malignancy, GOG, Woman, Immunotherapy, Risk, Pharmaceutical industry, Medical device, Vaccine

LAWRENCEVILLE, N.J., June 21, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that following a pre-planned interim safety review of 87 as treated patients (46 patients in the experimental arm and 41 patients in the control arm) randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that weekly doses of GEN-1 were well tolerated during a course of treatment that is given over six months in combination with standard neoadjuvant chemotherapy. No dose-limiting toxicities were reported.

Key Points: 
  • The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.
  • Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.
  • The Company also announced that more than 87% of the projected 110 patients have been enrolled in the OVATION 2 Study.

Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

Retrieved on: 
Thursday, February 17, 2022
Work, NASDAQ, Patient, Peritoneal cavity, Cancer, Time, Risk, Company, Recurrence, Toxic leukoencephalopathy, Interim, Ovarian cancer, PFS, Fast track (FDA), Immunotherapy, RNA, U.S. Securities and Exchange Commission, Phase, Neoplasm, Immunity, Security (finance), Tumor microenvironment, Private Securities Litigation Reform Act, Data monitoring committee, III, EOC, Safety, Paclitaxel, IV, Biologics license application, Surface epithelial-stromal tumor, Progression-free survival, Carboplatin, Woman, Cell proliferation, Malignancy, FDA, China Biologic Products, DSMB, Innovation Act, Research, Diagnosis, DNA, NK, GLOBE, Pharmaceutical industry, Medical device, Vaccine

LAWRENCEVILLE, N.J., Feb. 17, 2022 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that following a pre-planned interim safety review of 81 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported.

Key Points: 
  • The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.
  • Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.
  • The Company also announced that more than 75% of the projected 110 patients have been enrolled in the OVATION 2 Study.

Europe Gastro-Intestinal Stromal Tumors Market and Competitive Landscape Report 2021: Pipeline, Epidemiology, Valuations, Sales, Drug Forecasts, and Market Shares 2018-2026 - ResearchAndMarkets.com

Retrieved on: 
Friday, September 24, 2021
Health, Oncology, Surface epithelial-stromal tumor, Research, Epidemiology, Prevalence, Competitive landscape, Medical imaging

The "Europe Gastro-Intestinal Stromal Tumors Market and Competitive Landscape - 2021" report has been added to ResearchAndMarkets.com's offering.

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Global Gastro-Intestinal Stromal Tumors Market Research and Competitive Landscape Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 14, 2021
Health, Other Health, Surface epithelial-stromal tumor, Epidemiology, Research, Competitive landscape, G7, Prevalence, Medical imaging

The "Global Gastro-Intestinal Stromal Tumors Market and Competitive Landscape - 2021" report has been added to ResearchAndMarkets.com's offering.

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  • This research covers the following - Gastro-Intestinal Stromal Tumors treatment options, Gastro-Intestinal Stromal Tumors late-stage clinical trials pipeline, Gastro-Intestinal Stromal Tumors prevalence by countries, Gastro-Intestinal Stromal Tumors market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.
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SOTIO Presents Positive Biomarker Data from DCVAC/OvCa Phase 2 Study in First Line Ovarian Cancer at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021
Gynaecological cancer, Cancer, Life sciences, Biotechnology, Clinical medicine, Sotio, Ovarian cancer, Surface epithelial-stromal tumor

PRAGUE, Czech Republic, June 04, 2021 (GLOBE NEWSWIRE) -- SOTIO , a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of positive biomarker data from its Phase 2 trial with dendritic cell vaccine DCVAC/OvCa during a virtual poster presentation at the 2021 ASCO Annual Meeting.

Key Points: 
  • PRAGUE, Czech Republic, June 04, 2021 (GLOBE NEWSWIRE) -- SOTIO , a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of positive biomarker data from its Phase 2 trial with dendritic cell vaccine DCVAC/OvCa during a virtual poster presentation at the 2021 ASCO Annual Meeting.
  • DCVAC/OvCa is being developed as a first line treatment in adults with ovarian cancer.
  • The data demonstrate signs of efficacy and safety of DCVAC/OvCa combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma and provide strong rationale for potential study in larger clinical trials.
  • Our data indicate a potentially strong effect of DCVAC/OvCa in patients with ovarian cancer, predominantly in patients with immunologically cold tumors, which showed to be refractory in clinical trials with immunotherapy so far.

SOTIO to Present Biomarker Data from its SOV01 – DCVAC/OvCa Phase 2 Study in 1st line Ovarian Cancer at the 2021 ASCO Annual Meeting

Retrieved on: 
Tuesday, May 11, 2021
Clinical medicine, Medicine, Cancer, Gynaecological cancer, Oncology, Cancer treatments, Debulking, Surgical oncology, Ovarian cancer, CVac, Surface epithelial-stromal tumor, Chemotherapy

b'SOTIO , a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of a virtual poster at the 2021 ASCO Annual Meeting.

Key Points: 
  • b'SOTIO , a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of a virtual poster at the 2021 ASCO Annual Meeting.
  • The presentation focuses on potentially predictive biomarker data from a phase 2 study of SOTIO\xe2\x80\x99s dendritic cell vaccine (DCVAC/OvCa) combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma after primary debulking surgery.\nSOTIO\xe2\x80\x99s DCVAC Program is a cell therapy platform designed to improve efficacy compared to earlier generations of dendritic cell therapies by targeting multiple antigens and applying an immune-stimulatory technique.
  • SOTIO has created this vertically integrated, personalized cell therapy platform to enable the efficient manufacturing of product doses for one year of treatment at commercially attractive costs.\nTitle: Dendritic cell vaccine (DCVAC) combined with chemotherapy (CMT) in patients with newly diagnosed epithelial ovarian carcinoma (EOC) after primary debulking surgery (PDS): Biomarker exploratory analysis of a phase 2, open-label, randomized, multicenter trial\nPresenting Author: Lukas Rob, MD, PhD, University Hospital Kralovske Vinohrady (Prague, Czech Republic)\nA copy of the presentation materials can be accessed on the SOTIO website once the presentation concludes, and a recorded oral presentation focused on the data will be hosted on the online ASCO Media Library.\nSOV01 is a randomized, open-label, three-arm multicenter Phase II clinical trial evaluating DCVAC/OvCa in combination with first-line standard chemotherapy in women with newly diagnosed epithelial ovarian cancer following radical debulking surgery.\n'

Biotechs Zero in on Growing Ovarian Cancer Market as Pivotal Trials Advance Through Regulatory Agencies

Retrieved on: 
Monday, May 3, 2021
Gynaecological cancer, Anatomy, Gynaecology, Health, Cancer, Oncology, Ovarian cancer, Gynaecological neoplasia, Ovary, Breast cancer, Ovarian tumor, Surface epithelial-stromal tumor

The three major types of ovarian cancer are epithelial, accounting for 90% of cases, germ cell (3%), and sex cord-stromal (2%).

Key Points: 
  • The three major types of ovarian cancer are epithelial, accounting for 90% of cases, germ cell (3%), and sex cord-stromal (2%).
  • Most of the current information on factors associated with ovarian cancer risk is from studies of epithelial tumors.
  • The strongest risk factor for ovarian cancer is a family history of breast or ovarian cancer.
  • Because of the R&D activities projections for the market are optimistic for both the companies\' revenues and the patients need.

Biotechs Zero in on Growing Ovarian Cancer Market as Pivotal Trials Advance Through Regulatory Agencies

Retrieved on: 
Monday, May 3, 2021
Gynaecological cancer, Anatomy, Gynaecology, Health, Cancer, Oncology, Ovarian cancer, Gynaecological neoplasia, Ovary, Breast cancer, Ovarian tumor, Surface epithelial-stromal tumor

The three major types of ovarian cancer are epithelial, accounting for 90% of cases, germ cell (3%), and sex cord-stromal (2%).

Key Points: 
  • The three major types of ovarian cancer are epithelial, accounting for 90% of cases, germ cell (3%), and sex cord-stromal (2%).
  • Most of the current information on factors associated with ovarian cancer risk is from studies of epithelial tumors.
  • The strongest risk factor for ovarian cancer is a family history of breast or ovarian cancer.
  • Because of the R&D activities projections for the market are optimistic for both the companies\' revenues and the patients need.