DNX-2401 Demonstrates “Dramatic” Survival Benefit in Glioma

Excerpt:

“Treatment with the investigational agent DNX-2401 resulted in 20% of a cohort of patients with recurrent malignant glioma surviving more than 3 years from the time of treatment, according to phase I data published in the Journal of Clinical Oncology.

“In the dose-escalation study, patients were enrolled into the treatment-only group A (n = 25) or the treat-resect-treat group B (n = 12). Group A underwent stereotactic biopsy to document recurrence, followed by a single intratumoral injection of DNX-2401 at the assigned dose through the biopsy needle into the contrast-enhancing tumor mass. In group B, stereotactic biopsy and intratumoral injection of DNX-2401 through an implanted catheter was followed 2 weeks later by craniotomy with en bloc tumor resection, and then administration of a second DNX-2401 dose into several locations in the wall of the resection cavity.”

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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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New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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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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Cancer Clinical Trials Exclude Many Desperate Patients. Should That Change?

Excerpt:

“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.

“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”

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