"Glioblastoma is the most common and aggressive cancerous brain tumour in adults due to its resistance to therapy. Treatment usually involves surgery, followed by chemotherapy and radiation therapy. Despite these intensive efforts, in most cases tumour cells regrow after treatment and the cancer recurs,” reports Science Daily. At the moment, glioblastoma has a low survival rate of just 14.6 months from diagnosis. However, there may be a treatment option with the development of Berubicin, an anthracycline anticancer drug used for the treatment of malignant gliomas, as noted by Targeted Oncology. Some of the top companies that could prosper on such a development include WPD Pharmaceuticals Inc. (CSE:WBIO), AbbVie Inc. (NYSE:ABBV), Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN), AstraZeneca PLC (NYSE:AZN), and Clovis Oncology Inc. (NASDAQ:CLVS).
WPD Pharmaceuticals Inc. (CSE:WBIO) BREAKING NEWS: WPD Pharmaceuticals Inc. a clinical stage pharmaceutical company, is pleased to announce that is has engaged world-renowned Contract Research Organization, Worldwide Clinical Trials to coordinate and supervise Phase 1 and 2 clinical trials on its Berubicin drug candidate.
Berubicin is a new drug and one of the first anthracyclines proven to cross the blood-brain barrier to reach brain tumors. The discovery and further development of Berubicin can potentially extend the clinical use of anthracyclines to brain tumors, specifically Glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord.
WCT is a global CRO providing full-service drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase II and III trials to peri-approval studies. WCT offers clients expertise in neuroscience, cardiovascular, inflammation, rare disease, oncology and other therapeutic areas. They manage clinical trials across nearly 60 countries in North America, Latin America, Europe, Asia Pacific and Middle East. WCT will provide research services, implementation of start-up activities, organization and development for clinical trials being conducted by WPD in adult and pediatric populations with Glioblastoma, according to international standards of good clinical practice (ICH GCP) and other applicable regulatory requirements. These requirements include safety management, pharmaco-vigilancem and data management. WCT will also support WPD’s application for orphan drug designation, which if successful, has filing fee savings and other benefits.
60% of the program budget will be refunded by a grant already awarded to WPD by The National Center for Research and Development based in Poland under the European Union’s Smart Growth Operational Program.
Other related developments from around the markets include:
AbbVie Inc. (NYSE:ABBV) and I-Mab (Nasdaq: IMAB) announced that AbbVie and I-Mab have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. In addition, the two partners have the potential to expand the collaboration to additional transformative therapies. Lemzoparlimab is one of the leading drug candidates among I-Mab's proprietary and innovative pipeline. It is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development. Topline results of the recent phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients. Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. Full data will be presented at an appropriate scientific conference later this year.
Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) a biotechnology company developing novel therapeutics for the treatment of unmet medical needs, announced the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for trans sodium crocetinate (TSC) in COVID-19 patients. This IND, which incorporates pre-IND regulatory guidance from the FDA, describes an international clinical development program in the U.S. and EU, newly titled as Phase 1b/2b, testing the Company’s lead drug TSC in a total of approximately 424 COVID-19 patients with symptoms of impaired respiratory function and low oxygen levels. Low oxygen levels are a frequent result of damage to the lungs, often leading to organ failure – the leading cause of death in COVID-19 patients. Diffusion believes TSC’s oxygen-enhancing mechanism could provide an important new treatment option. The new IND details three studies, comprised of an open-label Phase 1b lead-in trial which, if successful, will be followed by two randomized double-blinded Phase 2b trials. The lead-in will test TSC in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID). Diffusion expects to begin dosing in this trial later this month, based on additional guidance received from the Romanian National Agency for Medicines and Medical Devices (NAMMD) and the Company’s submission of a responsive Clinical Trial Application amendment. The Company expects this trial to read-out by the end of Q3 2020. In addition to safety, the lead-in trial will collect data on possible increased oxygenation, thereby helping determine TSC dosing for follow-on studies.
AstraZeneca PLC (NYSE:AZN) will present new developments in pursuit of its ambition to eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, 19 to 21 September. AstraZeneca medicines and pipeline molecules feature in 114 abstracts at ESMO, a record for the Company, including 20 oral presentations and two Presidential Symposia. The data highlight the breadth of the portfolio of cancer medicines and the early-stage pipeline. Whether it is by treating cancer early or by developing tailored medicines across all stages of disease, these data have the potential to transform patient outcomes and survival.
Clovis Oncology Inc. (NASDAQ:CLVS) announced today that the U.S. Food and Drug Administration (FDA) approved the FoundationOne® Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca ® (rucaparib) tablets, recently approved for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. FoundationOne Liquid CDx is intended for use by health care professionals to help inform cancer treatment decisions in accordance with FDA-approved labeling and professional guidelines for patients with solid tumors. FoundationOne Liquid CDx is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca, the first PARP inhibitor approved for the treatment of BRCA1/2-mutant mCRPC.
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