Recurrence

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

Retrieved on: 
Wednesday, February 21, 2024

Topline Results Expected in Q2 2024

Key Points: 
  • "Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

HIMALAYA TECHNOLOGIES PARTNERS WITH RENOVI! TO TARGET MEDICAL TOURISM MARKET IN CARIBBEAN; ADDS CEO TO ADVISORY BOARD

Retrieved on: 
Monday, March 11, 2024

Additionally, the Company has appointed Renovi!’s CEO, David Burns, Ph.D., to its Advisory Board to guide its entry into this multi-billion dollar market, assist on mergers and acquisitions including a potential combination of Renovi!

Key Points: 
  • Additionally, the Company has appointed Renovi!’s CEO, David Burns, Ph.D., to its Advisory Board to guide its entry into this multi-billion dollar market, assist on mergers and acquisitions including a potential combination of Renovi!
  • The availability of the newest medical technologies and the cheaper cost of treatment in emerging nations are key market drivers enhancing market growth.
  • reinvents traditional outpatient rehabilitation by offering patients a “recovery vacation” at an upscale, beachfront medical resort with healthy diet, exercise, community and exceptional medical care.
  • The Dominican Republic is uniquely positioned as a medical tourism destination because of its low costs, proximity to the U.S., a well-established tourism infrastructure, and tax incentives for tourism investments.

Teladoc Health Expands Obesity & Weight Management Capabilities

Retrieved on: 
Thursday, March 7, 2024

The multidisciplinary care model is designed by clinicians experienced in obesity medicine and delivered with a tailored approach to weight management.

Key Points: 
  • The multidisciplinary care model is designed by clinicians experienced in obesity medicine and delivered with a tailored approach to weight management.
  • Clients can provide their populations with comprehensive and integrated clinical care, that also addresses wellbeing, mental health and social drivers of health in a personalized manner,” said Dr. Vidya Raman-Tangella, Teladoc Health Chief Medical Officer.
  • The Comprehensive Weight Management solution is customized for health plans and employers to meet the needs of their populations and reduce the cost of care for obesity-related medical expenses by going beyond care coordination to deliver:
    An evidence-based, personally tailored approach inclusive of comprehensive support from providers experienced in obesity management, health coaching, medical nutrition therapy, and integrated, highly accessible mental health support.
  • More information on Teladoc Health’s obesity and weight management programs can be found here .

Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer

Retrieved on: 
Monday, March 4, 2024

The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).

Key Points: 
  • The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).
  • The data were presented in a poster at the 2024 Multidisciplinary Head and Neck Cancers Symposium held February 29-March 2, 2024, in Phoenix, AZ.
  • Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11).
  • Observed adverse events were consistent with the known toxicity profile of iopofosine I 131, with cytopenias being the most common with all patients recovering.

American Urological Association Releases Salvage Therapy for Prostate Cancer Guideline

Retrieved on: 
Thursday, February 29, 2024

BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.

Key Points: 
  • BALTIMORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Today, the American Urological Association (AUA), in partnership with the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO), released the 2024 clinical practice guideline on salvage therapy for prostate cancer.
  • Understanding the evaluation and appropriate use of salvage therapies for patients with biochemical recurrence is a critical area of prostate cancer care.
  • “Thanks to the incredible expertise of the entire Panel, this guideline helps provide a roadmap that combines the latest advancements with thoughtful recommendations, empowering patients and clinicians alike.”
    This guideline has 30 recommendations and is a useful reference for effective evidence-based care related to salvage therapy for prostate cancer.
  • Salvage therapy for prostate cancer: AUA/ASTRO/SUO guideline part I: introduction and treatment decision-making at the time of suspected biochemical recurrence after radical prostatectomy.

Kiniksa Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Portfolio Execution

Retrieved on: 
Wednesday, February 28, 2024

HAMILTON, Bermuda, Feb. 28, 2024 (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported fourth quarter and full-year 2023 financial results and recent portfolio execution.

Key Points: 
  • Total revenue for the fourth quarter of 2023 was $83.4 million, compared to $61.9 million for the fourth quarter of 2022.
  • Total operating expenses for the fourth quarter of 2023 were $83.3 million, compared to $55.8 million for the fourth quarter of 2022.
  • Net income for the fourth quarter of 2023 was $25.2 million, compared to net income of $4.5 million for the fourth quarter of 2022.
  • Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, February 28, 2024, to discuss fourth quarter and full-year 2023 financial results and recent portfolio execution.

Myriad Genetics and National Cancer Center Hospital East in Japan Collaborate on Pan-Cancer MRD Monitoring Clinical Trial, SCRUM-MONSTAR-SCREEN-3

Retrieved on: 
Tuesday, February 27, 2024

Two of the three cohorts, including approximately 1,200 patients across more than 20 cancer types, will undergo MRD monitoring via Precise MRD.

Key Points: 
  • Two of the three cohorts, including approximately 1,200 patients across more than 20 cancer types, will undergo MRD monitoring via Precise MRD.
  • The goal of SCRUM-MONSTAR-SCREEN-3 is to generate high-quality, prospective, clinical evidence showing MRD testing can be broadly applied across cancer types and to patients with different disease severity or staging.
  • “First generation MRD tests have made remarkable progress monitoring disease recurrence and progression in cancer types with high tumor or variant burden.
  • “We’ve designed Precise MRD to be highly sensitive for application across all cancer types and look forward to this study demonstrating its utility in cancer care.”

CG Oncology Announces First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, February 27, 2024

IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the first patient has been dosed in the PIVOT-006 Phase 3 clinical trial of cretostimogene for the treatment of patients with intermediate-risk NMIBC following transurethral resection of the bladder tumor (TURBT).

Key Points: 
  • “The dosing of the first patient in our PIVOT-006 trial advances cretostimogene earlier in the treatment paradigm for NMIBC patients who face limited treatment options, frequent disease recurrence and repetitive surgery,” said Arthur Kuan, Chairman and Chief Executive Officer, CG Oncology.
  • The initial induction course is six weekly doses of cretostimogene containing 1x1012 VPs per milliliter.
  • The primary endpoint of this trial is overall RFS, with secondary endpoints including RFS at 12 and 24 months and PFS.
  • Cretostimogene is a novel therapy which has the potential to be a paradigm shift in how we might manage the ongoing burden of this highly recurrent aspect of bladder cancer.”

Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

Cost of sales was $19.9 million for the fourth quarter of 2023, compared to $2.9 million for the fourth quarter of 2022, respectively.

Key Points: 
  • Cost of sales was $19.9 million for the fourth quarter of 2023, compared to $2.9 million for the fourth quarter of 2022, respectively.
  • R&D expenses were $69.3 million for the fourth quarter of 2023, compared to $99.4 million for the fourth quarter of 2023.
  • G&A expenses were $141.7 million for the fourth quarter of 2023, compared to $84.4 million for the fourth quarter of 2022.
  • Apellis will host a conference call and webcast to discuss its fourth quarter and year end 2023 financial results and business highlights today, February 27, 2024, at 8:30 a.m.

Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries

Retrieved on: 
Tuesday, February 27, 2024

The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland.

Key Points: 
  • The Company's application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland.
  • The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites.
  • We look forward to working very closely with our European colleagues and will start by training site staff, pharmacists, and nurses.
  • We hope to open sites as quickly as possible, while applying to open additional sites in the approved countries and potentially adding additional countries in Europe."