Research Studies Progressing Towards New FDA Approved Treatments for Glioblastoma

PALM BEACH, Florida, March 3, 2020 /PRNewswire/ -- Although there is presently no cure for glioblastoma, researchers are continually inching closer to new and effective treatment options. Glioblastoma is a type of brain cancer that affects the astrocytes, which are a type of cell found in the brain and spinal cord. This form of cancer can occur anywhere astrocytes are found but most commonly develops in the frontal or temporal lobes of the brain. It's the most common type of malignant brain tumor among adults, and it is usually very aggressive, which means it can grow fast and spread quickly. Patients with this malignancy have many treatment options available to them, but presently, the goal of glioblastoma treatment is to slow and control tumor growth and help the patient live as comfortably and as well as possible. Although there is no cure, there are treatments to help ease symptoms. In many cases, surgery is recommended in combination with one or more other treatment techniques. The best possible treatment will depend on many factors that are unique to the individual patient, which is why it is important that the patient receive a treatment plan that's tailored to his/her individual needs. Active biotech and pharma companies in the markets this week include CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Karyopharm Therapeutics Inc. (NASDAQ: KPTI), China Pharma Holdings, Inc. (NYSE: CPHI), Trillium Therapeutics Inc. (NASDAQ: TRIL), Heat Biologics, Inc. (NASDAQ: HTBX).

Researchers are continually working to improve the glioblastoma survival rate. Patients have a wider range of treatment options than ever before, and new therapies are being introduced on a regular basis. Additionally, clinical studies are providing better insight into how different cancers and cell types respond to treatment, allowing oncologists to recommend more effective therapies for each patient. For instance, researchers have identified a specific protein that makes glioblastomas less responsive to a commonly prescribed chemotherapy drug; oncologists can test patients for this protein to determine if a different medication might be more effective before treatment even begins. CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) BREAKING NEWS:  CNS Pharmaceuticals Announces Brain Cancer Patient from Berubicin Phase 1 Trial Remains Cancer Free - CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announces as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme ("GBM"), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease.

In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.

"We are delighted to provide this update on Berubicin's potential capabilities given the unmet need for this aggressive disease," commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children's Memorial Health Institute, the largest pediatric hospital in Poland." WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company. Read this and more news for CNSP at:  https://www.financialnewsmedia.com/news-cnsp/     

Other recent developments in the biotech industry include:

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) recently announced positive top-line results from the randomized Phase 3 BOSTON study evaluating once-weekly XPOVIO® (selinexor) in combination with once-weekly Velcade® (bortezomib) and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade plus low-dose dexamethasone (Vd) in patients with multiple myeloma who have received one to three prior lines of therapy. The BOSTON study met its primary endpoint of a statistically significant increase in progression-free survival (PFS).  The median PFS in the SVd arm was 13.93 months compared to 9.46 months in the Vd arm, representing a 4.47 month (47%) increase in median PFS (hazard ratio=0.70; p=0.0066).  There were no new safety signals on the SVd arm and there was no imbalance in deaths between the two arms in the study.  The full top-line data will be submitted for presentation at upcoming medical meetings.

"We are thrilled to report these highly significant top-line results from the BOSTON study, the first randomized Phase 3 trial to demonstrate clinically and statistically significant activity of once-weekly XPOVIO in combination with a current standard of care treatment in patients with myeloma after one to three prior therapies," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. 

China Pharma Holdings, Inc. (NYSE: CPHI) recently announced that its subsidiary, Hainan Helpson Pharmaceutical & Biotechnology Co., Ltd. ("Helpson") launched a new product – the wash-free sanitizer.

During the outbreak of the novel coronavirus, there is a strong market demand for urgently needed disinfection products. Whether in professional medical institutions or daily life, daily disinfection has become a necessary step to avoid potential exposures to the virus.

In response to the government's call to combat the novel coronavirus and to address people's daily health protection needs, Helpson has leveraged the advantages of its pharmaceutical production facilities to launch this sterilization product in a short time. This product has received the production approval from the health authority. Helpson has initiated the production process and will deliver this new product to the market soon.

Trillium Therapeutics Inc. (NASDAQ: TRIL) recently provided an update on its TTI-621 and TTI-622 clinical programs.

"We have now completed the initial dose finding and signal seeking parts of our phase 1 study of intravenous TTI-621 at doses up to 0.5 mg/kg," said Dr. Jan Skvarka, President and Chief Executive Officer of Trillium. "The program continues to demonstrate clear single agent activity across a range of hematologic malignancies, as well as a strong tolerability profile. We believe that TTI-621, even at these low initial doses, is the only anti-CD47 agent that has shown meaningful single agent activity, including complete responses. Our immediate priority is to complete the ongoing monotherapy dose escalation under revised DLT criteria for thrombocytopenia. We are currently dosing at 1.0 mg/kg, or 5 times the dose level at which we observed initial single agent activity. Once we have defined the maximum tolerated dose (MTD), we intend to move TTI-621 into combinations with other agents in larger indications with high unmet need, namely acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS), peripheral T-cell lymphoma (PTCL) and other oncology indications.  We currently expect that we will identify the MTD and initiate one or more combination studies later this year."

Heat Biologics, Inc. (NASDAQ: HTBX) recently announced that the Company has dosed the first patient in the first Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care.

HS-130 is Heat's allogeneic cell line engineered to locally secrete the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, designed to augment antigen-specific CD8+ T cell response. HS-130 was manufactured by utilizing the Company's proprietary process to reprogram a live, genetically modified cancer cell line. In multiple preclinical models, these responses have demonstrated improved efficacy and safety using OX40L-Fc via cell-based delivery compared to systemic delivery of an OX40 agonist antibody in combination with HS-110.

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