Drug discovery

Optinose Completes Patient Recruitment in Pivotal Trial for XHANCE in Chronic Sinusitis

Friday, July 30, 2021 - 1:00pm

YARDLEY, Pa., July 30, 2021 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced it has successfully completed recruitment in the first of two pivotal clinical trials to evaluate the safety and efficacy of XHANCE® (fluticasone propionate) nasal spray as a treatment for patients with chronic sinusitis (CS).

Key Points: 
  • Today we are announcing completion of recruitment in the first of our pivotal CS trials, stated Ramy Mahmoud, M.D., MPH, President and Chief Operating Officer of Optinose.
  • Our clinical team is now focusing all of its recruitment effort on the second of our two pivotal CS trials, and we expect to complete enrollment in that trial before year-end.
  • The completion of recruitment for this trial keeps us on track to have top-line results in the first quarter of 2022, said CEO Peter Miller.
  • If successful, XHANCE may be the first FDA-approved drug product for chronic sinusitis.

Sigyn Therapeutics Announces Successful Completion of Animal Pilot Study

Thursday, July 29, 2021 - 3:05pm

The pilot study represents the first-in-mammal use of Sigyn Therapy in a clinical setting.

Key Points: 
  • The pilot study represents the first-in-mammal use of Sigyn Therapy in a clinical setting.
  • In the pilot animal study, an adult version of Sigyn Therapywas administered to two porcine (pig) subjects (each ~ 40 kilos) to evaluate the feasibility of a therapeutic protocol designed to support subsequent clinical studies.In the study, Sigyn Therapy was deployed on a standard dialysis hardware system and utilized conventional blood-tubing set configurations.
  • Craig Roberts, Chief Technical Officer at Sigyn Therapeutics, added, We are pleased with the results of our pilot study, which provides us with clinical evidence that our device can be safely used without complications or adverse events.
  • This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties.

Imago BioSciences Receives Orphan Designation From European Medicines Agency for Bomedemstat for the Treatment of Essential Thrombocythemia

Friday, July 30, 2021 - 1:02pm

Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).

Key Points: 
  • Imago BioSciences, Inc. (Imago) (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), today announced that the European Medicines Agency (EMA) has granted orphan designation for bomedemstat, a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of essential thrombocythemia (ET).
  • The Phase 2 clinical trial of bomedemstat for the treatment of ET continues to actively enroll globally ( NCT04254978 ).
  • Gaining this designation is an important regulatory milestone that gives us added momentum in advancing the development of bomedemstat.
  • Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of ET and MF, European Medicines Agency (EMA) Orphan Designation for the treatment of ET and MF, and PRIority MEdicines (PRIME) Designation by the EMA for the treatment of MF.

Immuno-oncology Clinical Trials Market Research Report 2021: Analysis by Phase (Phase I, Phase II, Phase III, Phase IV), Design (Interventional Trials, Observational Trials), & Indication - ResearchAndMarkets.com

Thursday, July 29, 2021 - 5:06pm

The "Immuno-oncology Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Design (Interventional Trials, Observational Trials), by Indication, by Region and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Immuno-oncology Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Design (Interventional Trials, Observational Trials), by Indication, by Region and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
  • The global immuno-oncology clinical trials market size is expected to reach USD 15.1 billion by 2028.
  • The rapidly growing field of Immuno-oncology has emerged as a novel therapeutic area within the oncology ecosystem, transforming the treatment of cancer.
  • At the end of 2019, over 40.0% of current immuno-oncology clinical experiments involved at least one location in the region
    Chapter 3 Immuno-oncology clinical trials Market: Variables, Trends, & Scope
    Chapter 4 Immuno-oncology Clinical Trials Market: Phase Segment Analysis
    4.1 Immuno-oncology Clinical Trials Market: Phase Market Share Analysis, 2020 & 2028

Global Fatigue Clinical Trials Review, H2 2021 - ResearchAndMarkets.com

Thursday, July 29, 2021 - 2:20pm

The "Fatigue - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Fatigue - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Fatigue - Global Clinical Trials Review, H2, 2021" provides an overview of the Fatigue Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Fatigue.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Clinical Trials by G7 Countries: Proportion of Fatigue to Central Nervous System Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Fatigue to Central Nervous System Clinical Trials

Gonorrhea Clinical Trials Review, H2 2021 Research Report - ResearchAndMarkets.com

Thursday, July 29, 2021 - 12:27pm

The "Gonorrhea - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Gonorrhea - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Gonorrhea - Global Clinical Trials Review, H2, 2021" provides an overview of the Gonorrhea Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Gonorrhea.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Aids in interpreting the success rates of clinical trials by providing a comparative scenario of completed and uncompleted (terminated, suspended or withdrawn) trials
    Facilitates clinical trial assessment of the indication on a global, regional and country level
    Clinical Trials by G7 Countries: Proportion of Gonorrhea to Infectious Disease Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Gonorrhea to Infectious Disease Clinical Trials

Mycovia Pharmaceuticals Announces Presentation of Oteseconazole (VT-1161) Phase 3 Data Demonstrating Safety and Efficacy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) at the 2021 IDSOG Annual Meeting

Thursday, July 29, 2021 - 1:00pm

Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.

Key Points: 
  • Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.
  • This meeting provides a chance to generate increased discussion with healthcare professionals about RVVC and the need for improved treatment options.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).
  • Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations and, if approved, could be the first FDA-approved treatment for RVVC.

Axcella Reports Second Quarter Financial Results and Provides Business Update

Thursday, July 29, 2021 - 12:28pm

Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.

Key Points: 
  • Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.
  • As we enter the second half of 2021, maximizing clinical trial enrollment and expanding Axcellas pipeline are our primary areas of focus.
  • Axcella continues to expect that its existing cash balance will be sufficient to meet the companys operating needs into the third quarter of 2022.
  • ET to discuss the companys financial results and other recent business updates.

Numinus Wellness Closes Q3 2021 With $63.2 Million Cash Position, Lab and Trial Advances, and Strategic Expansion into Psychedelic Neurology

Thursday, July 29, 2021 - 11:00pm

Numinus' condensed consolidated interim financial statements for the period ended May 31, 2021 and related management's discussion and analysis are available on Numinus' website at www.numinuswellness.com and under the Company's profile on SEDAR at www.sedar.com .

Key Points: 
  • Numinus' condensed consolidated interim financial statements for the period ended May 31, 2021 and related management's discussion and analysis are available on Numinus' website at www.numinuswellness.com and under the Company's profile on SEDAR at www.sedar.com .
  • Numinus Wellness (TSX-V: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies.
  • The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use.
  • At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Global Fabry Disease Clinical Trials Review, H2 2021 Report - ResearchAndMarkets.com

Thursday, July 29, 2021 - 9:16am

The "Fabry Disease - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Fabry Disease - Global Clinical Trials Review, H2, 2021" clinical trials has been added to ResearchAndMarkets.com's offering.
  • "Fabry Disease - Global Clinical Trials Review, H2, 2021" provides an overview of the Fabry Disease Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Fabry Disease.
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Clinical Trials by G7 Countries: Proportion of Fabry Disease to Genetic Disorders Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Fabry Disease to Genetic Disorders Clinical Trials