Mucositis

Monopar to Present at the H.C. Wainwright BioConnect Conference

Retrieved on: 
Vendredi, janvier 7, 2022
Therapy, COVID-19, Patient, Cancer, Life, Mucositis, Oropharyngeal cancer, Quality of life, Conference, MD, GLOBE, Nasdaq, Fine chemical, Pharmaceutical industry

WILMETTE, Ill., Jan. 07, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced that Chandler Robinson, MD, Monopars Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference.

Key Points: 
  • WILMETTE, Ill., Jan. 07, 2022 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced that Chandler Robinson, MD, Monopars Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference.
  • The presentation will be available for on-demand viewing starting on Monday, January 10, 2022 at 7:00am ET.
  • MonoparTherapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients.Monopar'spipeline consists of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in oropharyngeal cancer patients; camsirubicinfor the treatmentof advanced soft tissue sarcoma; a late-stage preclinical antibody, MNPR-101, for advanced cancers and severe COVID-19; and an early-stage camsirubicin analog, MNPR-202, for various cancers.
  • For more information, visit: www.monopartx.com .

Soligenix to Present at Upcoming Investor Conferences

Retrieved on: 
Jeudi, janvier 6, 2022
EMA, Vaccine, COVID-19, Priority review, Inflammation, Therapy, V6 PRV engine, Twitter, Security (finance), Contract, Infection, FDA, National Institute of Allergy and Infectious Diseases, Biomedical Advanced Research and Development Authority, Technology, Health care reform, Time, Government, Research, Defense Threat Reduction Agency, Head, BDP, Mucositis, DTRA, Form 10-Q, BARDA, National Institute, Nasdaq, Unitary state, IDR, Clinical trial, PRV, Severe acute respiratory syndrome coronavirus 2, Protalix BioTherapeutics, Development, Innovation, Company, Conference, Congress, NIAID, U.S. Securities and Exchange Commission, Project, Risk, Public health, LinkedIn, Specialization, T-cell lymphoma, Legislation, CTCL, Pharmaceutical industry, Video game

PRINCETON, N.J., Jan. 6, 2022 /PRNewswire/ --Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming virtual investor conferences below.

Key Points: 
  • PRINCETON, N.J., Jan. 6, 2022 /PRNewswire/ --Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Company will deliver a corporate presentation at the upcoming virtual investor conferences below.
  • Biotech Showcase: The Investor Conference for Innovators, held January 10 through 12, and 17 through 19, 2022 with presentations, one-on-one meetings, and networking.
  • Key members of Soligenix management will hold one-on-one meetings throughout both conferences.
  • If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected] .

Dusquetide Demonstrates Positive Anti-tumor Efficacy in Multiple Nonclinical Animal Studies

Retrieved on: 
Mardi, janvier 4, 2022
MCF-7, Population, Head, HNC, Company, Mucositis, Radiation, ER, Breast cancer, Patient, Nasdaq, Autophagy, SOM, Multiple myeloma, Acceleration, Pharmaceutical industry

Recent studies, recapitulating results from previously published studies , have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line.

Key Points: 
  • Recent studies, recapitulating results from previously published studies , have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line.
  • Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy.
  • The role of p62 is best characterized in multiple myeloma and breast cancer.
  • The MCF-7 cell line tested in the xenograft studies with dusquetide is both ER+ and responsive to anti-HER2 treatment.

Galera Announces Primary Endpoint Met Statistical Significance in Corrected Topline Efficacy Data of Phase 3 ROMAN Trial of Avasopasem

Retrieved on: 
Mardi, décembre 14, 2021
Therapy, Large-cell lung carcinoma, Failure, U.S. Securities and Exchange Commission, GC4419, Food, FDA, NDA, Investor, HNC, Toxicity, Ownership, BTD, Private Securities Litigation Reform Act, Nasdaq, RT, Incidence, COVID-19, Cancer, Annual report, SEC, Head, Breakthrough therapy, Risk, Radiation, Lung, News, CEO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cisplatin, Safety, Baozou Big News Events, Patient, GLOBE, Pancreatic cancer, Webcast, Health, Mucositis, CRO, Privacy, SBRT, Pharmaceutical industry, Phosphorus, Company, SOM

MALVERN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy (RT) in cancer, today announced that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM. Avasopasem has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the reduction of SOM induced by RT.

Key Points: 
  • The Company previously announced the Phase 3 ROMAN trial of avasopasem in SOM did not achieve statistical significance on the primary endpoint.
  • Upon further analysis, an error by the contract research organization (CRO) was identified in the statistical program.
  • ROMAN is our second randomized trial conducted in patients with head and neck cancer to achieve statistical significance and demonstrate improved clinical benefit.
  • ET to discuss the ROMAN Phase 3 data, including additional analyses from the full data set, and provide a general business update.

Monopar Advances Dosing of Camsirubicin to Higher Level Than Tested In Any Previous Clinical Trial

Retrieved on: 
Mercredi, décembre 8, 2021
U.S. Securities and Exchange Commission, Company, Doxorubicin, Research, Population, Review, Anthracycline, Oropharyngeal cancer, GLOBE, Sarcoma, Therapy, Security (finance), Disease, G-CSF, Neutropenia, Cardiotoxicity, Safety, Private Securities Litigation Reform Act, Quality of life, Cancer, Patient, All-comers track meet, Connective tissue, American Cancer Society, Life, MD, COVID-19, Mucositis, Clinical trial, Goal, Diagnosis, Doctor of Philosophy, Nasdaq, Life expectancy, STS, Pharmaceutical industry

This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial.

Key Points: 
  • This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial.
  • We are eager to continue evaluating progressively escalating dose levels of camsirubicin, which may demonstrate increasing anti-tumor activity.
  • Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.
  • It has been investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial.

Monopar Therapeutics Reports Third Quarter 2021 Financial Results and Recent Clinical Developments

Retrieved on: 
Vendredi, novembre 12, 2021
Quality of life, VOICE, Cancer, Private Securities Litigation Reform Act, G&A, Therapy, Mucositis, Drug discovery, Clinical trial, CRT, SOM, Heart, IND, Security (finance), Food, COVID-19, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Oropharyngeal cancer, Patient, Company, Liu v. Securities and Exchange Commission, GLOBE, Hydrogen chloride, SEC, Doxorubicin, Clonidine, Life, Chemoradiotherapy, FDA, Pharmaceutical industry, Lithium

WILMETTE, Ill., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2021 financial results and summarized recent clinical developments.

Key Points: 
  • First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.
    WILMETTE, Ill., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2021 financial results and summarized recent clinical developments.
  • In September 2021, Monopar initiated the Phase 1b clinical trial, and in October 2021, dosed the first patients.
  • Monopar continues to work on activating additional clinical sites in the U.S. for the Phase 1b clinical trial.
  • Results for the Third Quarter Ended September 30, 2021, Compared to the Third Quarter Ended September 30, 2020
    Cash and cash equivalents as of September 30, 2021, were $22.3 million.

Monopar Announces First Patient Dosed in Phase 1b Trial Evaluating Camsirubicin for the Treatment of Advanced Soft Tissue Sarcoma

Retrieved on: 
Mercredi, octobre 27, 2021
Cancer, MD, Research, Quality of life, Diagnosis, Disease, Connective tissue, CA, Oropharyngeal cancer, Security (finance), U.S. Securities and Exchange Commission, Patient, Private Securities Litigation Reform Act, FDA, Life expectancy, Cardiotoxicity, Life, Clinical trial, G-CSF, COVID-19, Sarcoma, Nasdaq, Therapy, American Cancer Society, Neutropenia, Doxorubicin, Mucositis, Population, GLOBE, STS, Pharmaceutical industry

We are very pleased to have dosed our first patient so quickly after trial initiation and so soon following our FDA allowance to proceed in early August.

Key Points: 
  • We are very pleased to have dosed our first patient so quickly after trial initiation and so soon following our FDA allowance to proceed in early August.
  • An estimated 21 patients will be enrolled in the Phase 1b clinical trial, which is active and recruiting in the US.
  • It has been investigated previously in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial.
  • Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body.

Enzychem Lifesciences Announces Positive Results for Phase 2 U.S. Study of EC-18 in Chemoradiation-Induced Oral Mucositis

Retrieved on: 
Mercredi, octobre 20, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Breakthrough therapy, Clinical trial, AES, Pain, Caregiver, Pharynx, Mouth, Șaeș, Head, SAE, Twitter, Patient, Cisplatin, Toxicity, Incidence, KOSDAQ, Chemoradiotherapy, Mucositis, Eating, SOM, Safety, FDA, Management of ulcerative colitis, CEO, Dentistry, Homeostasis, Radiation, Malnutrition, Stage 2, Dehydration, Inflammation, Edwards Lifesciences, Key Stage 1, Hospital, Pharmaceutical industry

Enzychem Lifesciences (KOSDAQ: 183490) announced today positive Phase 2 results from a U.S. clinical trial of its lead candidate EC-18 in chemoradiation-induced oral mucositis (CRIOM).

Key Points: 
  • Enzychem Lifesciences (KOSDAQ: 183490) announced today positive Phase 2 results from a U.S. clinical trial of its lead candidate EC-18 in chemoradiation-induced oral mucositis (CRIOM).
  • EC-18, a novel, first-in-class, small molecule oral immunomodulator, reduced the duration and incidence of severe oral mucositis in patients with head and neck cancer undergoing concurrent chemoradiation therapy.
  • Patients with the most severe form of oral mucositis often have to discontinue or modify their cancer treatment.
  • "We are delighted to announce these positive results from our Phase 2 U.S. study, which confirm that EC-18 is safe and well-tolerated, said Ki-Young Sohn, CEO & Chairman, Enzychem Lifesciences.

Galera Announces Results of Phase 3 ROMAN Trial of Avasopasem for Radiotherapy-Induced Severe Oral Mucositis

Retrieved on: 
Mardi, octobre 19, 2021
Esophagitis, Mouth, Head, Privacy, Technology, Private Securities Litigation Reform Act, COVID-19, Large-cell lung carcinoma, Patient, Cisplatin, Lung cancer, Incidence, LAPC, Pancreatic cancer, PEG, Failure, Prognosis, SOM, Therapy, Mucositis, Annual report, Program, U.S. Securities and Exchange Commission, Neoplasm, FDA, Nasdaq, CEO, Safety, GC4419, GLOBE, Health, Survival, Ownership, Ulcer, HNC, Inflammation, Bleeding, Cancer, SBRT, SEC, Radiation, NSCLC, Fast track (FDA), Company, Hospital, Pharmaceutical industry, Phosphorus

MALVERN, Pa., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced results from the Phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results.

Key Points: 
  • We recently initiated a Phase 2b trial of GC4711 in combination with SBRT in LAPC based on promising tumor and survival outcome benefits observed in a Phase 1/2 pilot trial.
  • In addition, enrollment is ongoing in a Phase 1/2 trial of GC4711 in combination with SBRT in patients with NSCLC.
  • The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin.
  • Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth.

Galera Appoints Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer

Retrieved on: 
Mardi, octobre 12, 2021
Auxilium, Therapy, Columbia University, General manager, Juno Therapeutics, Biotechnology, Ownership, General counsel, Radiation, Safety, Cancer, SEC, Quality of life, Compliance, Nasdaq, Company, Incidence, University of Illinois at Chicago College of Dentistry, COVID-19, Human resources, Growth, Government, Endo International, U.S. Securities and Exchange Commission, Berkeley, Senior, Leadership, Celgene, Large-cell lung carcinoma, Wistar Institute, Annual report, Lung cancer, CCO, Princeton University, SOM, Mucositis, Lobbying, Economics, Private Securities Litigation Reform Act, BMS, Thomas Jefferson University, Fast track (FDA), University of Pennsylvania Law School, Privacy, GLOBE, CAR, Health, Health policy, University, CEO, Amgen, Patient, Pharming, Pancreatic cancer, Head, GC4419, Management, Pharmaceutical industry

Prior to joining Galera, Mark served as Vice President & U.S. Business Unit Head for Bristol Myers Squibbs (BMS) CAR T cell therapy franchise.

Key Points: 
  • Prior to joining Galera, Mark served as Vice President & U.S. Business Unit Head for Bristol Myers Squibbs (BMS) CAR T cell therapy franchise.
  • At BMS, he was responsible for building core U.S. commercial capabilities and the successful launch execution of Breyanzi and Abecma.
  • Prior to BMS, Mark was Vice President of Sales at Juno Therapeutics, a biotechnology company acquired by Celgene in 2018.
  • Prior to Juno, Mark worked at Amgen for 15 years in a variety of U.S. and international commercial operations roles.