Palm Beach, FL –November 21, 2019 – The U.S. Food and Drug Administration (FDA) as part of its mission, is responsible for protecting the public health by assuring the safety, effectiveness, and security of human drugs, vaccines and medical devices. There has recently been an uptick in the focus on cancerous brain tumors. The FDA recently announced that it has awarded 12 new clinical trial research grants totaling more than $15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country but two-thirds (67%) of the new awards fund clinical studies of products for use in various rare and aggressive cancers. One such cancer is the glioblastoma multiforme… a very dangerous brain tumor. Cancer.com describes glioblastoma as the most common type of brain cancer in adults. It is less common in children. It continued: “Despite continued efforts over several decades to develop new therapies for glioblastoma, none has appreciably improved how long patients live. Most people with this type of brain cancer, in fact, survive for less than 2 years.” Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Q BioMed Inc. (OTCQB: QBIO), Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA), Aravive, Inc. (NASDAQ: ARAV), Bristol-Myers Squibb Company (NYSE: BMY).
Johns Hopkins says this on their site: “If brain tumors were sharks, the glioblastoma multiforme, or GBM, would be the great white. More than any other brain cancer, GBM inspires fear because of its almost unstoppable aggression. In fact, just a generation ago, the diagnosis of GBM meant facing a prognosis of months, or even weeks — not years — to live. But that picture is changing. Clinicians and researchers are advancing treatment and prolonging life in patients with this brain tumor. Despite all the advances in treatment, we still don’t understand what causes GBMs. They are not hereditary.”
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS: CNS Pharmaceuticals Filed Request with FDA for Pre-IND Meeting for Berubicin – CNS Pharmaceuticals, a biotechnology company specializing in the development of novel treatments for brain tumors, filed a Pre-IND meeting request for Berubicin for IV for the Treatment of Glioblastoma Multiforme to the US Food and Drug Administration Division of Oncology Products 2, Center for Drug Evaluation and Research.
In its request, the Company outlined its rationale for the continued investigation of the compound and detailed key questions for the FDA, including its permission to utilize the supply of Berubicin acquired from Reata Pharmaceuticals Inc. in the planned upcoming Phase II clinical trial. The company has performed a preliminary purity testing and analysis on Reata’s supply of Berubicin and verified that it is 99.9% pure.
“We believe that utilizing the supply of Berubicin we acquired from Reata could offer the Company significant costs savings and eliminate the excess risk and time associated with manufacturing complex drugs,” stated CEO of CNS, John M. Climaco. Read this and more news for CNSP at: https://financialnewsmedia.com/news-cnsp/
Other recent developments in the biotech industry include:
Q BioMed Inc. (OTCQB: QBIO) announced FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company’s FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.
Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain. The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.
Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) recently announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis. Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling.
Kiniksa’s Breakthrough Therapy application was based on final data from an open-label Phase 2 clinical trial of rilonacept in a range of pericarditis populations that were included in a poster presentation at the American Heart Association (AHA) Scientific Sessions on November 16, 2019.
“We are pleased that the FDA has granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis, a painful and debilitating autoinflammatory cardiovascular disease,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa.
Aravive, Inc. (NASDAQ: ARAV) recently announced new positive data from the ongoing Phase 1b portion of the Phase 1b/2 clinical trial of AVB-500 in platinum-resistant recurrent ovarian cancer patients. The data from the first 31 patients treated at the 10mg/kg dose are maturing and affirm earlier findings on the relationship between AVB-500 levels and anti-tumor response. In this data analysis, high serum drug levels of AVB-500 were strongly predictive of anti-tumor activity with statistically significant correlation to progression-free survival (PFS; p=0.0066). PFS is the primary endpoint for platinum-resistant ovarian cancer clinical trials.
At the 10 mg/kg dose, patients that met or exceeded the minimal efficacious concentration of AVB-500 demonstrated a greater than four-fold increase in median PFS over those with low exposure (8.1 vs. 1.8 months; p=0.0016) and approximately two-fold improvement in overall response rate (ORR; 29% vs. 14%), including one complete response (CR). Patients who achieved sufficient AVB-500 exposure also showed improvements in duration of response (from 7.6 to 3.9 months) and clinical benefit rate (82% vs. 43%), with reduced chance of progressing by 3.2-fold (from 57% to 18%).
Bristol-Myers Squibb Company (NYSE: BMY) recently announced results for one of the co-primary endpoints from CheckMate -915, a randomized Phase 3 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone for the adjuvant treatment of patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of disease) melanoma. A statistically significant benefit was not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1%. The Data Monitoring Committee recommended that the study continue unchanged. The study remains double-blinded and will continue to assess the other co-primary endpoint of RFS in the all-comer (intent-to-treat) population.
CheckMate -915 is a Phase 3, randomized, placebo controlled, double-blind study evaluating Opdivo in combination with Yervoyversus Opdivo monotherapy, an approved standard of care, in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (no evidence of disease) melanoma. Patients enrolled in the trial had no prior anti-cancer treatment for melanoma, except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy after neurosurgical resection for central nervous system lesions. The trial randomized 1,943 patients to receive either Opdivo 240 mg intravenously every two weeks and Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for one year.
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