IV

New Shockwave Coronary IVL Publication Shows Similar Outcomes in Women And Men

Retrieved on: 
Thursday, November 9, 2023

The one-year results from Disrupt CAD III and IV trials were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) .

Key Points: 
  • The one-year results from Disrupt CAD III and IV trials were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI) .
  • In the patient-level pooled analysis, titled “Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes,” use of IVL for lesion preparation of severely calcified lesions had similar safety and effectiveness in women and men at a one-year follow-up.
  • At one-year, major adverse cardiovascular event (MACE) rates were not different between women and men (12.3% vs 13.2%, p=0.52) and there was no difference between women and men in target lesion failure (TLF, 10.4% vs. 11.2% p=0.43).
  • The European lead is Nieves Gonzalo, MD, PhD, Consultant Interventional Cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

Cancer Drug Parity Act Gains Strong Support from Leading Healthcare Organizations

Retrieved on: 
Wednesday, November 8, 2023

The International Myeloma Foundation (IMF), which leads the Coalition to Improve Access to Cancer Care (CIACC), fervently supports the Cancer Drug Parity Act, recognizing its profound impact on myeloma patients and their families.

Key Points: 
  • The International Myeloma Foundation (IMF), which leads the Coalition to Improve Access to Cancer Care (CIACC), fervently supports the Cancer Drug Parity Act, recognizing its profound impact on myeloma patients and their families.
  • The Cancer Drug Parity Act would put the needs of patients first to ensure that patients, along with their healthcare providers, can choose the treatment option they deem is most appropriate”.
  • ONS is proud to support the Cancer Drug Parity Act and commends the bill’s sponsors for their leadership in ensuring parity for oral cancer treatments.”
    Recognizing the pressing need for equitable access to cancer treatments, Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), emphasized the critical issue of disparities in cost-sharing for oral chemotherapy medications.
  • For more information on the Cancer Drug Parity Act and its potential impact on cancer care, please visit https://www.access2cancercare.org/ .

The Oncology Institute Reports Third Quarter 2023 Financial Results and Reaffirms Full Year 2023 Guidance

Retrieved on: 
Wednesday, November 8, 2023

Third Quarter 2023 Results (for the three months ended September 30, 2023)

Key Points: 
  • Third Quarter 2023 Results (for the three months ended September 30, 2023)
    Consolidated revenue for Q3 2023 was $82.0 million, an increase of 26.3% compared to Q3 2022, and a 2.3% increase compared to Q2 2023.
  • Revenue for patient services the nine months ended 2023 was $157.3 million, up 32.4% compared to the nine months ended 2022.
  • Gross profit in the nine months ended 2023 was $45.2 million, an increase of 23.9% compared to the nine months ended 2022.
  • TOI will host a conference call and webcast on Wednesday, November 8, 2023 at 5:00 p.m. (Eastern Time) to discuss third quarter results.

Iterum Therapeutics to Provide Business Update and Report Third Quarter 2023 Financial Results on November 14, 2023

Retrieved on: 
Tuesday, November 7, 2023

Management will host a conference call at 8:30 a.m.

Key Points: 
  • Management will host a conference call at 8:30 a.m.
  • ET that day to discuss the Company’s financial results and provide an update on its business.
  • To access the call please dial 833-470-1428 (domestic) or 929-526-1599 (international) and refer to Access Code 388052.
  • The audio webcast can be accessed under “Financials & Filings” in the Investors section of the Company’s website at www.iterumtx.com following the call.

Matinas BioPharma Announces Positive in vivo Efficacy Results of Oral LNC Docetaxel Formulation in a Melanoma Model

Retrieved on: 
Tuesday, November 7, 2023

Currently, docetaxel is administered intravenously and can be associated with significant side effects and toxicities.

Key Points: 
  • Currently, docetaxel is administered intravenously and can be associated with significant side effects and toxicities.
  • “We are excited to report new in vivo data demonstrating the therapeutic efficacy of an oral LNC formulation of docetaxel,” said Dr. James J. Ferguson, Chief Medical Officer of Matinas .
  • “The study shows reductions in tumor size comparable to systemic intravenous docetaxel in a well-validated mouse melanoma model,” he added.
  • Additional analyses of the data are ongoing, and we are preparing them for presentation at upcoming scientific meetings.”
    Purpose: Document the efficacy of an oral LNC docetaxel formulation to target and treat tumors, with both negative (untreated) and positive (IV docetaxel) controls.

Gate Neurosciences Announces Positive Topline Human EEG Biomarker Results Demonstrating Dose-Dependent Target Activation in Phase 1 Study of Apimostinel

Retrieved on: 
Tuesday, November 7, 2023

Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.

Key Points: 
  • Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.
  • Results demonstrated a dose-dependent increase in qEEG pharmacodynamic biomarkers of NMDA receptor target activation from baseline, compared with subjects who received placebo.
  • Apimostinel was also generally well-tolerated with no ketamine-like dissociative side effects, highlighting its novel mechanistic approach of enhancing synaptic function.
  • Gate plans to initiate a Phase 2 study of zelquistinel to confirm efficacy in MDD in Q1 2024.

Hospital PMI® at 52.1%; October 2023 Hospital ISM® Report On Business®

Retrieved on: 
Tuesday, November 7, 2023

The Business Activity Index expanded for the second consecutive month.

Key Points: 
  • The Business Activity Index expanded for the second consecutive month.
  • The New Orders Index remained in expansion for the second straight month, and the Employment Index returned to contraction territory.
  • LeMaster continues, "While slightly lower than the previous month, volume metrics remained in the growth range; Hospital Business Survey Committee respondents commented that operations were stable.
  • There is concern that a potential shortage of IV fluids and related products could cause serious issues going into flu season."

Ovid Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Friday, November 3, 2023

The remaining 13% interest in these potential future milestone payments and royalties was acquired by Ligand in October 2023.

Key Points: 
  • The remaining 13% interest in these potential future milestone payments and royalties was acquired by Ligand in October 2023.
  • General and administrative expenses were $6.8 million for the three months ended September 30, 2023, as compared to $7.6 million for the same period in 2022.
  • The decrease reflects the impact of headcount reductions conducted as part of organizational changes made in the first half of 2023.
  • Total operating expenses were $12.1 million for the three months ended September 30, 2023, as compared to $12.8 million for the same period last year.

Prelude Announces Strategic Pipeline Progress and Updates, including its Partnership with AbCellera, and Reports Third Quarter Financial Results

Retrieved on: 
Wednesday, November 1, 2023

WILMINGTON, Del., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, today provides strategic pipeline updates and reports third quarter financial results.

Key Points: 
  • Given the overlap with the CDK9 program, Prelude does not plan to advance PRT1419 further at this time.
  • Given the focus of the Company on SMARCA2 and CDK9, Prelude will not advance the program further and is actively pursuing further clinical development with external partners.
  • “We made significant progress in the third quarter with our four clinical stage molecules and, as planned, conducted a rigorous assessment of each program.
  • We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

AIM ImmunoTech Announces Abstract Accepted for Poster Presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting

Retrieved on: 
Monday, October 30, 2023

OCALA, Fla., Oct. 30, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced that an abstract from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine (“UPMC") has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting being held November 1 – 5, 2023 in San Diego, CA and virtually.

Key Points: 
  • OCALA, Fla., Oct. 30, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced that an abstract from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine (“UPMC") has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting being held November 1 – 5, 2023 in San Diego, CA and virtually.
  • The abstract concerns a Phase 2 single arm efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with AIM’s drug Ampligen and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer.
  • The abstract authors include Robert Edwards, MD, Chief Medical Officer of the UPMC Community and Ambulatory Services Division and Co-Director of the Women’s Cancer Research Center at the UPMC Hillman Cancer Center.
  • Details for the presentation are as follows: