Aggressive fibromatosis

Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

Retrieved on: 
Tuesday, April 9, 2024
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Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

Key Points: 


Orphan designation: Nirogacestat Treatment of soft tissue sarcoma, 17/10/2019 Positive

Immunome To Acquire AL102, A Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals

Retrieved on: 
Tuesday, February 6, 2024
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Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.

Key Points: 
  • Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.
  • AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy.
  • AL102 is a potential once-daily oral treatment for desmoid tumors.
  • A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala Pharmaceuticals, Inc. in connection with the transaction.

Immunome to Acquire AL102, a Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, OTCQX, MRI, Patient, Prevalence, Pain, Aggressive fibromatosis, VWAP, Plantar fibromatosis, Fibromatosis, FDA, Orphan, NDA, Food, Disability, Radiation, Cancer, Pharmaceutical industry

Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.

Key Points: 
  • Completion of the transaction is subject to customary conditions including Ayala obtaining the requisite stockholder approval.
  • AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy.
  • AL102 is a potential once-daily oral treatment for desmoid tumors.
  • A.G.P./Alliance Global Partners is acting as strategic advisor to Ayala Pharmaceuticals, Inc. in connection with the transaction.

OGSIVEO™ (nirogacestat) Now Available from Onco360 as the First and Only FDA-Approved Treatment for Adults with Progressing Desmoid Tumors Who Require Systemic Treatment

Retrieved on: 
Thursday, November 30, 2023
Oncology, Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Cough, Woman, Aggressive fibromatosis, Therapy, Toxicity, Rash, Progression-free survival, Stomatitis, Abdominal pain, Upper respiratory tract infection, Headache, Specialty pharmacy, Risk, Fatigue, Patient, Pharmacy, PFS, Plantar fibromatosis, Diarrhea, Nausea, HIV disease progression rates, Pharmaceutical industry, Medical imaging

Ogsiveo™ is an oral gamma secretase inhibitor for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

Key Points: 
  • Ogsiveo™ is an oral gamma secretase inhibitor for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
  • “Onco360 is excited to partner with the team at SpringWorks Therapeutics and become a specialty pharmacy partner for Ogsiveo™,” said Benito Fernandez, Chief Commercial Officer.
  • Desmoid tumors mostly affect people between the ages of 15 and 60 years, but they can occur at any age.
  • In children, desmoid tumors most often occur between the ages of 15 and 16 years.

Desmoid Tumors Drug Pipeline Research Report 2023: Comprehensive Insights About 12+ Companies and 12+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 16, 2023
Health, Pharmaceutical, Plantar fibromatosis, NDA, Aggressive fibromatosis, Acquisition, Research, Safety, Toxicity, Therapy, Disease, Clinical trial, Patient, FDA, Transducin, Mergers and acquisitions, New Drug Application, Nirogacestat, Orphan, Discovery, News, Medical imaging, Pharmaceutical industry

This pipeline report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in Desmoid Tumors pipeline landscape.

Key Points: 
  • This pipeline report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in Desmoid Tumors pipeline landscape.
  • This report provides an in-depth analysis of the Desmoid Tumors pipeline, covering both clinical and nonclinical stage products.
  • The report offers comprehensive insights into the current scenario and growth prospects within the Desmoid Tumors indication.
  • Companies and academic institutions are actively working to assess challenges and identify opportunities that could impact the research and development of therapies for Desmoid Tumors.

Ayala Pharmaceuticals Announces AL102 Receives Orphan Drug Designation for Desmoid Tumors

Retrieved on: 
Monday, November 6, 2023
Aggressive fibromatosis, FDA, Organ dysfunction, Incidence, Food, Chronic pain, OTCQX, DT, Head, Plantar fibromatosis, Quality of life, Abdominal wall, Medicine, Patient, Food and Drug Administration, Diagnosis, GSI, Plasma protein binding, Pharmaceutical industry

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AL102, a Gamma Secretase Inhibitor (GSI), for the treatment of desmoid tumors (DT).

Key Points: 
  • REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AL102, a Gamma Secretase Inhibitor (GSI), for the treatment of desmoid tumors (DT).
  • Orphan drug designation is granted by the FDA to drugs and biologics intended for treatment, prevention or diagnosis of a rare disease or condition that affects fewer than 200,000 people in the U.S. at the time of designation.
  • Under the FDA’s Orphan Drug Act, orphan drug status provides incentives, including tax credits, grants and waiver of certain administrative fees for clinical trials, and seven years of market exclusivity following drug approval.
  • “Receiving FDA orphan drug status for AL102 underscores the significant unmet need for novel treatment options for people living with desmoid tumors.

Ayala Pharmaceuticals Presents Positive Interim Data from RINGSIDE Pivotal Phase 2/3 Trial of AL102 in Desmoid Tumors at ESMO Congress 2022

Retrieved on: 
Monday, September 12, 2022
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The data are being featured in an oral presentation today at the European Society for Medical Oncology (ESMO) Congress 2022.

Key Points: 
  • The data are being featured in an oral presentation today at the European Society for Medical Oncology (ESMO) Congress 2022.
  • The results presented today give us increased confidence in the potential for AL102 to improve the lives of patients with desmoid tumors.
  • For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 ( RINGSIDE ).
  • AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors ( RINGSIDE ).

Amyloid Precursor Protein Secretase Inhibitors Pipeline Market Report 2022: Comprehensive Insights About 5+ Companies and 5+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Monday, August 1, 2022
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Amyloid beta, Brain, III, Food, Route, GSI, Discovery, Alzheimer's disease, Adenoid cystic carcinoma, Therapy, News, Clinical trial, ACC, AD, US Foods, Administration, FDA, Aggressive fibromatosis, Patient, Drug, Route of administration, II, Plantar fibromatosis, Petrochemical, Medical imaging, Fine chemical, Pharmaceutical industry, Notch, Adenoid, Amyloid

This "Amyloid precursor protein secretase inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Amyloid precursor protein secretase inhibitors pipeline landscape.

Key Points: 
  • This "Amyloid precursor protein secretase inhibitors - Pipeline Insight, 2022" report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Amyloid precursor protein secretase inhibitors pipeline landscape.
  • Amyloid precursor protein secretase inhibitors: Emerging Drugs Chapters
    This segment of the Amyloid precursor protein secretase inhibitors report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery.
  • Amyloid precursor protein secretase inhibitors: Therapeutic Assessment
    This segment of the report provides insights about the different Amyloid precursor protein secretase inhibitors drugs segregated based on following parameters that define the scope of the report.
  • Amyloid precursor protein secretase inhibitors pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

SpringWorks Therapeutics Announces Nirogacestat Achieved Primary and All Key Secondary Endpoints in Phase 3 DeFi Trial in Adult Patients with Progressing Desmoid Tumors

Retrieved on: 
Tuesday, May 24, 2022
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-- NDA Submission to the U.S. FDA Planned for Second Half of 2022 --

Key Points: 
  • In addition, the trial met all key secondary endpoints, with nirogacestat demonstrating statistically significant improvements as compared to placebo in objective response rate (ORR) and patient-reported outcomes (PROs).
  • Desmoid tumors are aggressive soft-tissue tumors that can lead to severe negative outcomes for patients, including long-lasting pain, disfigurement, and amputation.
  • In rare cases, when vital organs are impacted, desmoid tumors can also be life-threatening, said Saqib Islam, Chief Executive Officer of SpringWorks.
  • DeFi ( NCT03785964 ) is an ongoing, global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors.

The Desmoid Tumor Research Foundation Closes Care Gaps through Virtualized Multidisciplinary Cancer Care Platform

Retrieved on: 
Friday, February 4, 2022
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As is the case with many rare tumors, medical expertise and research programs for desmoid tumors are limited and often siloed across academic research facilities.

Key Points: 
  • As is the case with many rare tumors, medical expertise and research programs for desmoid tumors are limited and often siloed across academic research facilities.
  • The DTRF Virtual Tumor Board program leverages the OncoLens Multidisciplinary Cancer Care Continuum platform to facilitate the virtualized meetings.
  • The mission of The Desmoid Tumor Research Foundation (DTRF) is to aggressively fund research to accelerate the development of improved therapies, and ultimately find a cure for desmoid tumors.
  • More than 9,000 cancer providers and 36,500 cancer patients across the U.S. rely on OncoLens to support their cancer programs and the care delivered