Study Evaluating VBI-1901 Enrolling Recurrent GBM Patients in Second Dose Group

Excerpt:

“An Independent Data and Safety Monitoring Board (DSMB) unanimously recommended that the Phase 1/2 clinical trial evaluating VBI Vaccines’ VBI-1901 continue to enroll patients with recurrent glioblastoma (GBM) in a second study arm.

“The positive review recommended the study continue without modification, after scanning through all safety data from the first group of patients, who received the lowest VBI-1901 dose. Enrollment now has commenced for the second, intermediate-dose study arm.”

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Carboxyamidotriazole Orotate Shows Promising Activity in Brain Cancers

Excerpt:

“Carboxyamidotriazole orotate (CTO) in combination with temozolomide (Temodar), with or without radiotherapy, produced positive safety and efficacy results in a phase Ib study of patients with glioblastoma (GBM) or anaplastic gliomas.

“Forty-two patients were divided into 2 cohorts and received treatment. Cohort 1 included 27 patients with recurrent, temozolomide-refractory anaplastic gliomas or GBM. Twenty-one patients were assigned to a regimen of 219 to 812.5 mg/m2 of once-daily CTO in escalating doses and 6 were assigned to a fixed daily dose of 600 mg of CTO. All 27 patients received 150 mg/m2 of temozolomide on days 1 to 5 of each 28-day cycle.”

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NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma

Excerpt:

“NovoCure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.

“NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.”

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Re-engineered Cold Virus Increases Brain Cancer Patients’ Survival, Phase 1 Trial Shows

Excerpt:

“Re-engineering a common cold virus to attack the deadliest kind of brain tumor extended the survival of patients whose tumor returned after various treatments, including surgery, a Phase 1 clinical trial shows.

“While patients with glioblastoma usually live a median of six months, half were still alive at 9/12 months after receiving the re-engineered virus. And 20 percent lived for three years or longer.”

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Tumor-Treating Fields for Glioblastoma Do Not Negatively Impact Quality of Life

Excerpt:

“The addition of tumor-treated fields to standard therapy with temozolomide prolonged deterioration-free survival without negatively influencing health-related quality of life among patients with glioblastoma, according to a secondary analysis of a phase 3 clinical trial published in JAMA Oncology.

“However, tumor-treating fields, or TTFields (Optune, Novocure) — alternating electrical fields delivered via four transducer arrays at an intermediate frequency of 200 MHz (1-3 V/cm) placed on the shaved scalp of patients and connected to a portable medical device — also caused skin irritation in more than half of patients.”

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Bevacizumab/Lomustine Combinations Falls Short in Phase III Glioblastoma Trial

Excerpt:

“Treatment with lomustine (Gleostine) plus bevacizumab (Avastin) provided a slightly improved progression-free survival (PFS), but did not demonstrate an overall survival (OS) advantage over treatment with lomustine alone in patients with progressive glioblastoma, according to results of a randomized phase III trial published in theNew England Journal of Medicine.

“There were a total of 329 OS events (75.3%) in patients who received the combination, which did not meet the endpoint for a statistically significant benefit. The median OS was 9.1 months (95% CI, 8.1-10.1) in the group of patients who received the combination of lomustine and bevacizumab and 8.6 months (95% CI, 7.6-10.4) in the monotherapy group (HR, 0.95; 95% CI, 0.74-1.21). Locally assessed PFS was 4.2 months in the combination group versus 1.5 months in the monotherapy group (HR, 0.49; 95% CI, 0.39-0.61).”

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For Now, Sequencing Cancer Tumors Holds More Promise Than Proof

Excerpt:

“People diagnosed with cancer understandably reach for the very best that medical science has to offer. That motivation is increasingly driving people to ask to have the DNA of their tumors sequenced. And while that’s useful for some malignancies, the hype of precision medicine for cancer is getting far ahead of the facts.

“It’s easy to understand why that’s the case. When you hear stories about the use of DNA sequencing to create individualized cancer treatment, chances are they are uplifting stories. Like that of Ben Stern.”

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Diffusion Pharmaceuticals Begins Phase 3 Clinical Trial with TSC in Glioblastoma Multiforme

Excerpt:

“Diffusion Pharmaceuticals Inc. DFFN, +2.38% (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced that a Phase 3 clinical trial using its lead small molecule trans sodium crocetinate (“TSC”) in patients with newly-diagnosed inoperable glioblastoma multiforme (“GBM”) brain cancer, is now open for enrollment. The trial, which has been named INTACT (INvestigating Tsc Against Cancerous Tumors), follows a previous Phase 2 GBM study in which the inoperable patient subgroup showed a nearly four-fold increase in survival compared with historical controls when TSC was added to their treatment regimen (40% alive at two years vs. 10.4%). TSC’s innovative mechanism of action affects the tumor micro-environment, making treatment-resistant cancer cells more susceptible to the tumor-killing power of conventional radiation therapy (“RT”) and chemotherapy (temozolomide) by re-oxygenation of the hypoxic portion of the tumor. The Company believes that a largely intact GBM tumor vasculature with limited surgical resection is conducive to TSC’s tumor re-oxygenation properties, and that this contributed to the survival increase in the Phase 2 GBM inoperable patient subgroup.”

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Electric Fields Therapy Improved Survival for Glioblastoma

Excerpt:

“The addition of tumor-treating fields to maintenance temozolomide chemotherapy significantly delayed progression and improved overall survival in patients with glioblastoma who had received standard radiochemotherapy compared with maintenance temozolomide alone, according to final results of a trial published in JAMA.

“Tumor-treating fields use low-intensity, alternating electric fields delivered via transducer arrays applied to the scalp. Patients treated with combined tumor-treating fields and temozolomide had a 37% improvement in progression-free and overall survival.”

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