HGG

Cellectar Awarded $2 Million Grant to Expand Its Ongoing Phase 1 Study of Iopofosine I 131 in Pediatric Brain Tumors

Retrieved on: 
Thursday, September 22, 2022
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The funding allows for an expansion from the Part 1a into the Part 1b portion of the companys ongoing Phase 1 pediatric study.

Key Points: 
  • The funding allows for an expansion from the Part 1a into the Part 1b portion of the companys ongoing Phase 1 pediatric study.
  • The currently ongoing Phase 1a is designed to determine the safety, tolerability, and initial efficacy of iopofosine in pediatric brain tumors whereas the Phase 1b is designed to identify the dose and dosing regimen that results in optimal efficacy.
  • Unfortunately, patients with HGGs often have very poor prognoses, with limited treatment options, said James Caruso, president and CEO of Cellectar.
  • The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA

Retrieved on: 
Tuesday, August 23, 2022
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Under applicable UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to pediatric patients. The sponsor must develop an overall Plan to select the specific form or stage of the disease to be treated, to adapt the dosing and administration of the medicine for pediatric physiology, and to evaluate the safety and efficacy of the medicine in pediatric patients. Further, the Plan must include not just general focus areas, aims and approaches -- it must include the full design of the specific clinical trials to be carried out, including all aspects required for clinical trial approvals, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints. 

Key Points: 
  • BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).
  • The Company's approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG.
  • The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators.
  • Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG.

Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA

Retrieved on: 
Tuesday, August 23, 2022
Brain, Medicines and Healthcare products Regulatory Agency, Patient, University, Glioblastoma, Technology, GBM, Safety, Survival, Disease, HGG, Risk, Toxic leukoencephalopathy, MAA, Consultant, Comment, SEC, U.S. Securities and Exchange Commission, Northwest Biotherapeutics, Medicine, Company, Biotechnology, Immunotherapy, MHRA, News, Cancer, Adult, Genta (company), Ovarian cancer, Private Securities Litigation Reform Act, OTCQB, Plan, PIP, Pharmaceutical industry

BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).  The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L. 

Key Points: 
  • BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP).
  • The Company's approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG.
  • The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators.
  • Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG.

Proactive news headlines including Riversgold Ltd, Patrys Ltd, Great Boulder Resources and Technology Metals Australia

Retrieved on: 
Wednesday, August 10, 2022
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Key Points: 
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    Maximus Resources Ltd (ASX:MXR) has executed a binding agreement to acquire the Kemble prospect, situated three kilometres north of its Wattle Dam Project, near Kambalada in Western Australia.
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    Meeka Metals Ltd (ASX:MEK) has hit exceptionally high-grade gold at the St Annes target, part of the wholly-owned Murchison Gold Project in WA.
  • Proactive has produced over 300,000 articles and 20,000 executive interviews since it was established in 2006.
  • For more information on how Proactive can help you make a difference, email us at [email protected]

FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech's NT-I7 for the treatment of Glioblastoma Multiforme

Retrieved on: 
Wednesday, July 13, 2022
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Dr Se Hwan Yang,Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "We are excited that the FDA granted NTI7 an ODD in the treatment of glioblastoma multiforme.

Key Points: 
  • Dr Se Hwan Yang,Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "We are excited that the FDA granted NTI7 an ODD in the treatment of glioblastoma multiforme.
  • We look forward to continuing our collaboration with FDA, as we explore the benefits of NT-I7 in treating people with GBM in combination with other anti-cancer treatments, including immunotherapies".
  • [2]Current studies in GBM include study NIT-107 in newly diagnosed GBM patients and study NIT-120 in recurrent GBM patients.
  • [3]
    The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

SonALAsense Achieves Significant Clinical, Growth and Funding Milestones Toward its Mission to Soundly Defeat Cancer

Retrieved on: 
Tuesday, June 28, 2022
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SonALAsense is working on two trials to evaluate the therapeutic potential of SONALA-001 SDT for DIPG and rGBM .

Key Points: 
  • SonALAsense is working on two trials to evaluate the therapeutic potential of SONALA-001 SDT for DIPG and rGBM .
  • The DIPG trial is actively recruiting and the rGBM clinical trial will begin recruiting shortly.
  • SDT utilizes SONALA-001 (a drug) in combination with MR-guided focused ultrasound (a device) to selectively target and kill tumor cells.
  • Follow SonALAsense on Twitter and LinkedIn and visit our website: https://sonalasense.com/
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220628005315/en/

Kiyatec Announces New Clinical Evidence in High Grade Glioma Accepted for Presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) 2022

Retrieved on: 
Thursday, June 2, 2022
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Kiyatec, a leader in functional precision oncology, announced new clinical evidence of its proprietary ex vivo 3D cell culture technology use in high-grade glioma will be presented at ASCO 2022.

Key Points: 
  • Kiyatec, a leader in functional precision oncology, announced new clinical evidence of its proprietary ex vivo 3D cell culture technology use in high-grade glioma will be presented at ASCO 2022.
  • As a first-time ASCO presenter and exhibitor, Kiyatec will present its Clinical Services and Drug Development Services capabilities at ASCOs first-ever Innovation Hub at kiosk #IH01.
  • The ASCO meeting will be held in Chicago June 3-7, 2022.
  • In this updated cohort of 42 patients with high grade glioma, 3D Predict Glioma prospectively predicted patient response to standard of care temozolomide (TMZ), regardless of MGMT methylation status.

Cellectar Reports Financial Results for Year Ended December 2021 and Provides a Corporate Update

Retrieved on: 
Monday, March 21, 2022
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Cash used in operating activities during the twelve months ended December31, 2021 was approximately $22.6 million.

Key Points: 
  • Cash used in operating activities during the twelve months ended December31, 2021 was approximately $22.6 million.
  • Research and Development Expense: R&D expense for the year ended December31, 2021 was approximately $17.6 million, compared to approximately $10.1 million for year ended December 31, 2020.
  • General and Administrative Expense: G&A expense for year ended December31, 2021 was $6.6 million compared to approximately $5.2 million for the year ended December31, 2020.
  • These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

Brain Cancer Canada To Fund Barrier Breaking Chemistry Research Targeting Glioblastoma

Retrieved on: 
Tuesday, November 30, 2021
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The research has identified an approach to potentially breaching barriers that are holding back effective brain cancer therapies.

Key Points: 
  • The research has identified an approach to potentially breaching barriers that are holding back effective brain cancer therapies.
  • Brain Cancer Canada has made these funds available thanks to the generous support from its donors, including Scotia Wealth Management, Yamana Gold, and Hampton Securities.
  • "This is the second time in as many months that we have been able to fund up-and-coming Canadian research through our all-volunteer organization," said Angela Scalisi, Chair of Brain Cancer Canada.
  • To learn more about Brain Cancer Canada, please visit www.braincancercanada.ca
    For inquiries, please contact: Marc Peeters, Director Partnerships and Stakeholders at Brain Cancer Canada, [email protected], 416 918 6678

Chimerix Announces Positive ONC201 Data in Recurrent H3 K27M-mutant Diffuse Midline Glioma to Be Presented at the Society for Neuro-Oncology Annual Meeting

Retrieved on: 
Friday, November 19, 2021
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DURHAM, N.C., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced the presentation of positive data from its 50-patient efficacy analysis of ONC201 for the treatment of recurrent H3 K27M-mutant diffuse midline glioma. ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist for the treatment of recurrent gliomas that harbor the H3 K27M- mutation.

Key Points: 
  • "The ONC201 data to be presented at SNO show impressive and consistent results in a disease where life expectancy is exceedingly limited.
  • There currently are no effective therapeutic options for patients with recurrent disease after radiation other than palliation.
  • ONC201 results are particularly notable in light of extended wash-out periods required to ensure isolation of ONC201 single agent effect.
  • It sets the stage for future study of ONC201 earlier in treatment," said Mike Sherman, Chief Executive Officer of Chimerix.