U.S. Now Has Most Virus Cases, BSGM To Develop COVID-19 Drug, FDA Nod For BMY

Today’s Daily Dose brings you news about BioSig Technologies’ foray into COVID-19 drug development, FDA approval of Bristol-Myers’ multiple sclerosis drug, delay in FDA panel review of Intercept Pharma’s NASH drug candidate, and positive results of VBL Therapeutics’ ovarian cancer trial.

Read on…

BioSig Technologies Inc.’s (BSGM) majority-owned subsidiary NeuroClear Technologies Inc. has acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19).

The orally administered, broad-spectrum anti-viral agent, which goes by the name Vicromax, has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing, noted the Company.

The Company intends to pursue the development of Vicromax for the treatment of COVID-19 through FDA-approved clinical trials.

BSGM closed Thursday’s trading at $6.13, up 58.40%.

The FDA has approved Bristol-Myers Squibb Co.’s (BMY) ZEPOSIA 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

ZEPOSIA for the treatment of adults with relapsing-remitting multiple sclerosis in the European Union is currently under review by the European Medicines Agency, with a decision expected in the first half of 2020.

Before initiation of treatment with ZEPOSIA, all patients require assessments including a recent complete blood count including lymphocyte count (within six months or after discontinuation of prior MS therapy), an ECG to determine whether preexisting conduction abnormalities are present, a recent liver function test (within six months), and consideration of current and prior medications, including vaccinations. For patients with a history of uveitis or macular edema, an ophthalmic assessment is required, the Company added.

BMY closed Thursday’s trading at $52.25, up 5.88%.

The FDA’s advisory committee meeting scheduled to review Intercept Pharmaceuticals, Inc.’s (ICPT) New Drug Application for Obeticholic acid in liver fibrosis due to nonalcoholic steatohepatitis, which had previously been tentatively scheduled for April 22, 2020, is now tentatively scheduled for June 9, 2020.

The final FDA decision date remains June 26, 2020.

The Company submitted its Marketing Authorization Application for Obeticholic acid in liver fibrosis due to nonalcoholic steatohepatitis to the European Medicines Agency in December 2019.

ICPT closed Thursday’s trading at $67.70, up 9.18%.

A planned interim analysis of VBL Therapeutics’ (VBLT) OVAL study has yielded encouraging results.

The OVAL study compares the combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer.

The independent Data Safety Monitoring Committee, which reviewed the data and assessed CA-125 response, confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended that the study be continued.

The CA125 (cancer antigen 125) is the gold standard tumor marker in ovarian cancer. Serum level of CA125 is used to monitor response to chemotherapy, relapse, and disease progression in ovarian cancer patients. (Source: Role of CA125 in predicting ovarian cancer survival – a review of the epidemiological literature. J Ovarian Res 2, 13 (2009)).

The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%, the Company noted.

VBLT closed Thursday’s trading at $1.46, up 28.07%.

COVID-19 Update:

The number of confirmed cases of COVID-19 infection in the U.S. is over 85,600, which has surpassed that of China’s, and the death toll is 1,280, according to Johns Hopkins University. New York, the worst-hit state in the U.S., has 38,977 confirmed cases and 466 deaths. (Source: Worldometer).

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