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DFFN

Diffusion Pharmaceuticals

$0.22

-0.0013 (-0.58%)

16:08
11/19/19
11/19
16:08
11/19/19
16:08

Diffusion Pharmaceuticals announces increased survival in TSC plus SOC trial

Diffusion Pharmaceuticals announced increased survival in inoperable glioblastoma patients enrolled in the 19-patient, open-label, dose-escalation lead-in portion of its Phase 3 study with Trans Sodium Crocetinate, or TSC, plus standard of care, or SOC. In an earlier Phase 2 study testing TSC in newly diagnosed glioblastoma multiforme, or GBM, brain cancer patients, an almost fourfold increase in two-year survival was seen versus historical controls in inoperable patients. The current Phase 3 INTACT trial is designed to examine this finding in a fully powered safety and efficacy registration study, which, if successful, could be the basis for U.S. FDA approval. In the INTACT trial, subjects are randomized at baseline to SOC for first-line treatment of GBM plus TSC, or to SOC alone. The SOC for GBM is temozolomide plus radiation therapy for 6 weeks, followed by 28 days of rest, then by 6 cycles of post-radiation temozolomide treatment. In a modification to the Phase 2 dosing regimen, patients in the INTACT trial will also receive high-dose TSC during the post-radiation chemotherapy phase. A 19-patient, open-label, dose-escalation lead-in portion to the INTACT trial was recently completed, sending a positive safety signal across all patients receiving TSC. In addition, six of the seven patients who received the high dose TSC treatment are still alive, with a median survival at the present time of 14.3 months. This is compared with 9.2 months for the historical standard of patients with inoperable GBM. Since six of the TSC-treated patients are still alive, median survival time is actually increasing with the passage of time, suggesting the INTACT trial may confirm or better the efficacy findings seen in the Phase 2 study. Patients' abilities to perform their daily activities as measured by Karnofsky performance scores increased from the baseline following completion of high dose treatment with TSC. Investigators have also reported instances of inoperable GBM patients treated with the higher dose TSC regimen leaving hospice or returning to work after treatment in the open-label portion of the study.

DFFN Diffusion Pharmaceuticals
$0.22

-0.0013 (-0.58%)

03/20/19
HCWC
03/20/19
NO CHANGE
Target $10
HCWC
Buy
Diffusion price target raised to $10 from $1.25 at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth raised his price target for Diffusion Pharmaceuticals to $10 from $1.25 and reiterates a Buy rating on the shares following the company's Q4 results. The target reflects the company's 15-for-1 stock reverse split, which occurred on December 14, 2018.

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Southwestern Energy

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UNT

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