Ino

Bellerophon Provides Clinical Program Update and Reports First Quarter 2022 Financial Results

Retrieved on: 
Wednesday, May 11, 2022

WARREN, N.J., May 11, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the first quarter ended March 31, 2022.

Key Points: 
  • WARREN, N.J., May 11, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the first quarter ended March 31, 2022.
  • The Phase 3 program builds on positive top-line results from the Companys previously reported Phase 2 studies for INOpulse for the treatment of fILD.
  • Research and development expenses for the first quarter ended March 31, 2022 were $4.4 million, compared to $3.6 million in the first quarter of 2021.
  • General and administrative expenses for the first quarter ended March 31, 2022 were $1.2 million, compared to $2.3 million in the first quarter of 2021.

Claritas Announces Approval from Australian Ethics Committee to Begin Phase 1 Trial of R-107

Retrieved on: 
Tuesday, April 5, 2022

HREC approval is the final regulatory step prior to initiation of the clinical study.

Key Points: 
  • HREC approval is the final regulatory step prior to initiation of the clinical study.
  • In addition to the Phase 2a clinical study in PAH, Claritas will also initiate a Phase 2 study in PPHN.
  • Following completion of the Phase 1 study, Claritas will again seek such funding for the costs of Phase 2 studies of R-107 in the treatment of
    sepsis and ARDS.
  • Claritas Pharmaceuticals, Inc. ("Claritas") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing, and delivering innovative human therapeutics.

Bellerophon Provides Clinical Program Update and Reports Full-Year 2021 Financial Results

Retrieved on: 
Thursday, March 31, 2022

WARREN, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the year ended December 31, 2021.

Key Points: 
  • WARREN, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (Bellerophon or the Company), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today provided a clinical program update and reported financial results for the year ended December 31, 2021.
  • Our balance sheet, with $24.7 million in cash and cash equivalents, provides us with continued resources to advance our late-stage development programs.
  • The Phase 3 program builds on positive top-line results from the Companys previously reported Phase 2 studies for INOpulse for the treatment of fILD.
  • The decrease was primarily attributable to the decrease in expenses related to the discontinuation of the COVID-19 trial in 2021.

The Global Inhaled Nitric Oxide Delivery Systems Market is Estimated to Grow from USD 247.5 Million in 2020 to USD 434.2 Million by 2027 - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 17, 2022

The "Inhaled Nitric Oxide Delivery Systems Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Inhaled Nitric Oxide Delivery Systems Market" report has been added to ResearchAndMarkets.com's offering.
  • The global Inhaled Nitric Oxide Delivery Systems market is estimated to grow from USD 247.5 million in 2020 to USD 434.2 million by 2027, at a CAGR of 6.9%.
  • Inhaled Nitric Oxide (INO), a minimally invasive therapy, is being investigated for the treatment of diseases linked with reversible pulmonary vasoconstriction and pulmonary hypertension in children and adults.
  • The key players profiled in Inhaled Nitric Oxide Delivery Systems market analysis are:

Third Pole Therapeutics Closes $25M Financing - eNOfit™ Wearable Device Now Ready for Clinical Trials

Retrieved on: 
Thursday, February 3, 2022

WALTHAM, Mass., Feb. 3, 2022 /PRNewswire/ -- Third Pole Therapeutics , a privately held company developing critical life-sustaining cardio-pulmonary therapies, announced today that it has achieved several significant milestones that include closing a $25M round of financing, and that eNOfit, the Company's fully miniaturized wearable device, is ready for clinical trials.

Key Points: 
  • WALTHAM, Mass., Feb. 3, 2022 /PRNewswire/ -- Third Pole Therapeutics , a privately held company developing critical life-sustaining cardio-pulmonary therapies, announced today that it has achieved several significant milestones that include closing a $25M round of financing, and that eNOfit, the Company's fully miniaturized wearable device, is ready for clinical trials.
  • We also welcome our new investors who have joined us in support of this important mission."
  • Two decades later, Third Pole has successfully created a scalable technology that delivers nitric oxide for inhalation, instantly, on-demand, and in unlimited quantities.
  • Third Pole's two novel platforms include eNOfit a miniaturized wearable device for home and travel and eNOcare, a lightweight portable in-hospital device.

Third Pole Therapeutics to Participate in H.C. Wainwright BioConnect and BIO Partnering at JPM during J.P. Morgan 40th Annual Healthcare Conference

Retrieved on: 
Thursday, January 6, 2022

CEO Bill Athenson will present recent business and clinical development activities and anticipated milestones during the H.C. Wainwright BioConnect Conference.

Key Points: 
  • CEO Bill Athenson will present recent business and clinical development activities and anticipated milestones during the H.C. Wainwright BioConnect Conference.
  • Mr. Athenson will also be available for virtual one-on-one meetings with registered investors and pharmaceutical companies at BIO Partnering at JPM.
  • Third Pole Therapeutics develops and delivers critical life-sustaining cardio-pulmonary therapies.
  • Third Pole's two novel platforms include a miniaturized wearable device for home and travel and a lightweight portable in-hospital device.

Claritas Outlines Development Strategy for R-107 for Multiple Diseases, Disorders and Injuries

Retrieved on: 
Tuesday, January 4, 2022

Claritas is poised to accelerate development of R-107 for treatment of numerous diseases, disorders and injuries, stated Robert Farrell, Claritas President and CEO.

Key Points: 
  • Claritas is poised to accelerate development of R-107 for treatment of numerous diseases, disorders and injuries, stated Robert Farrell, Claritas President and CEO.
  • Our development strategy is straightforward, as follows:
    Phase 1 Study in Q1 2022: The first step is completion of our Phase 1 clinical study to demonstrate that R-107 is safe in humans.
  • Depending on how it is administered, R-107 can target multiple diseases, disorders, and injuries.
  • Claritas Pharmaceuticals, Inc. ("Claritas") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing, and delivering innovative human therapeutics.

Claritas to Develop R-107 for Treatment of PPHN, a Potentially Fatal Pulmonary Disorder in Newborns

Retrieved on: 
Wednesday, December 22, 2021

Inhaled nitric oxide (iNO) is the only drug approved for the treatment of PPHN.

Key Points: 
  • Inhaled nitric oxide (iNO) is the only drug approved for the treatment of PPHN.
  • Claritas expects to initiate a Phase 2 study of R-107 in the treatment of PPHN by year-end 2022.
  • Claritas believes that R-107 could address this issue, due in part to its ease of administration, and projected lower cost vis--vis iNO administration.
  • Claritas Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs.

Bellerophon Reports Positive Top-Line Data from Phase 2 Acute Dose Escalation Study of INOpulse® for Treatment of Pulmonary Hypertension Associated with Sarcoidosis

Retrieved on: 
Friday, December 17, 2021

WARREN, N.J., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced positive top-line data from a recently completed Phase 2 dose escalation study (PULSE-PHPF-002) evaluating the acute hemodynamic benefit of INOpulse® via right heart catheterization for the treatment of pulmonary hypertension associated with sarcoidosis (PH-Sarc).

Key Points: 
  • The Phase 2 trial was designed as a proof of concept study to determine if iNO could demonstrate hemodynamic benefit in PH-Sarc.
  • Key results included:
    All 8 subjects demonstrated decreases in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) across the doses of INOpulse utilized in the study.
  • No treatment-emergent adverse events (TEAEs) or serious adverse events (TESAEs) occurred during the acute hemodynamic dose escalation phase of the study.
  • Sarcoidosis associated pulmonary hypertension has a median survival of approximately five years after development of the pulmonary hypertension.

INOVIO Presents Clinical Results of its DNA Medicines INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab) in the Treatment of Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 2020 Annual Meeting

Retrieved on: 
Friday, November 20, 2020

The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM.

Key Points: 
  • The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival for patients with newly diagnosed GBM.
  • INO-5401, INO-9012 and Libtayo, and the combination of these products have not been approved or evaluated by any Regulatory Authority worldwide for the treatment of newly diagnosed GBM.
  • INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA.
  • INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA.