Palm Beach, FL – February 11, 2020 – Pediatric brain tumors are abnormal growths that arise in the brain during childhood. Although brain tumors are rare overall, they are the most common solid tumor among children. What’s important to remember is that children are not simply miniature adults. Brain tumors in children behave differently than brain tumors in adults. What’s more, children require treatment that is tailored not just to their tumor type, but also to their age and development. A recent report from Market Research Future describes the sector as follows: “Pediatric brain tumor is uncontrolled or abnormal growth of normal cell in the brain in children. Brain tumors mainly are of two types, cancerous (malignant) and noncancerous (benign). It is second most common type of cancer in children and it comprise about 25% of childhood cancer. The cases of pediatric tumors are increasing globally that leading the growth of the market. Advanced diagnostic technology and new treatments are also major driving forces of the market. Rising healthcare infrastructure, extended insurance cover, government initiatives, and emerging economies are driving the market. Rising funding for R&D and clinical trials as well as FDA approvals are also major growth factors for global pediatric brain tumor market. The global pediatric brain tumor market is growing at the CAGR of ~4.1% during the forecast period and expected to reach US$ 1659.4 million by 2023.” Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), AbbVie Inc. (NYSE: ABBV), AstraZeneca PLC (NYSE: AZN), Pfizer Inc. (NYSE: PFE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO).
The global pediatric brain tumor market has been evaluated as a steady growing market and it is expected to continue growing in the near future. Increasing cases of pediatric brain tumors are leading the market growth. Various research initiatives taken by government, NGOs and healthcare providers are major driving forces of this market. The report continued: “Considering the global scenario of the market, North America holds the largest market share owing to various factors such as increasing cases of pediatric brain tumors and related medical complications. Europe is the second largest market where the countries like Germany and UK are holding the largest market share. In 2014, about 10,000 new cases of pediatric brain tumors were observed. New cases of pediatric brain tumor are rapidly growing in Asia Pacific region. Additionally, improving healthcare sector, government initiatives to improve public health and rising healthcare spending are driving the growth for Asia Pacific pediatric brain tumor market. Due to low knowledge of disease, limited availability of medical facilities, Middle East and Africa (ME&A) is likely to have a limited growth in the market.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Announces Collaboration with European Partner to Expand Clinical Trials to Pediatric Brain Tumors – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, today announced its plan to initiate a Phase I clinical trial for Berubicin in pediatric brain cancer in Poland in collaboration with WPD Pharmaceuticals, Inc. (CSE: WBIO) (“WPD”), a Polish corporation founded by Dr. Waldemar Priebe, the founder of the Company.
The Company, in collaboration with WPD, will conduct the upcoming Phase I clinical trial at Children’s Memorial Health Institute (“Children’s Memorial”), the largest pediatric hospital in Poland. The Company believes this Phase I trial of Berubicin at Children’s Memorial represents the first ever investigation of an anthracycline and topoisomerase II inhibitor in pediatric brain tumors. WPD and CNS are currently working with Children’s Memorial to complete documentation for the upcoming study and EMA scientific advice meeting.
As previously announced, CNS entered into a sublicense agreement with WPD which granted WPD commercial rights in a limited territory to Berubicin, including research and development. Subsequently, WPD was awarded a $6 million grant from the EU/Polish National Center for Research and Development. WPD plans to utilize funds from the grant to fund the upcoming Phase I trial and CNS is committed to fully support these studies with its internal expertise.
“We are extremely excited to further expand the scope of Berubicin and potentially bring a new hope for pediatric brain tumor patients in Poland and subsequently around the world,” stated John Climaco, CEO of CNS Pharmaceuticals. “We look forward to initiating what we believe to be the first investigation of a unique topoisomerase II inhibitor that appears to be able to cross the blood-brain barrier in pediatric brain tumors as we continue to drive the clinical development of Berubicin in the upcoming Phase II trial in adult patients.” Read this and more news for CNSP at: https://www.financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
AbbVie Inc. (NYSE: ABBV) recently announced financial results for the fourth quarter and full year ended December 31, 2019. “Our strong performance this quarter completes another excellent year for AbbVie,” said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. “The launches of Skyrizi and Rinvoq are going extremely well, and we are entering 2020 with substantial momentum. We also look forward to completing the planned Allergan acquisition in the first quarter.”
Worldwide net revenues were $8.704 billion, an increase of 4.8 percent on a reported basis, or 5.3 percent operationally. Excluding the unfavorable impact of international HUMIRA net revenues due to biosimilar competition, fourth-quarter net revenues grew 11.0 percent operationally.
AstraZeneca PLC (NYSE: AZN) recently announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).
The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.
Pfizer Inc. (NYSE: PFE) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE
(rituximab),1a potential biosimilar to MabThera® (rituximab).2,3 RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1 The CHMP’s opinion will now be reviewed by the European Commission, with a regulatory decision anticipated in the first half of 2020.
“Biosimilars like RUXIENCE can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are committed to bringing biosimilars like RUXIENCE to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost. If approved, RUXIENCE would become Pfizer’s fifth oncology biosimilar to receive regulatory approval in Europe.”
Inovio Pharmaceuticals, Inc. (NASDAQ: INO) recently announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for treatment of Recurrent Respiratory Papillomatosis or RRP. RRP is a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections, a condition that causes noncancerous tumor growths leading to life-threatening airway obstructions, and occasionally can progress to cancer. Currently, the disease is incurable and is mostly treated by surgery, which temporarily restores the airway. The tumor almost always recurs and the surgery must be repeated, often multiple times a year. RRP can severely impact the quality of life for those living with the disease.
The open-label, multicenter Phase 1/2 trial will enroll approximately 63 subjects in the U.S. and will evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in subjects with HPV 6 and/or 11-associated RRP who have required at least two surgical interventions per year for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of INO-3107, one every three weeks. The primary efficacy endpoint will be a doubling or more in the time between surgical interventions following the first dose of INO-3107 relative to the frequency prior to study therapy. Upon obtaining sufficient safety and potential efficacy data in adults, Inovio plans to expand the trial to include pediatric patients as well as a potential booster regimen.
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