BCLI Slips On FDA Feedback, OTIC Plunges As Ménière's Disease Trial Fails, CLNN On Watch

(RTTNews) - Today's Daily Dose brings you news about disappointing results from Otonomy's phase III trial of OTIVIDEX in Ménière's disease, FDA'S feedback related to BrainStorm's NurOwn cell therapy, Fast Track designation for Celsion's ovarian cancer drug candidate, and upcoming milestone of Clene.

Read on…

1. BrainStorm Cell Asked To Generate Addnl. Data for NurOwn cell therapy

The FDA has advised BrainStorm Cell Therapeutics Inc. (BCLI) to generate additional clinical data for NurOwn cell therapy, which is under a phase III trial for the treatment of amyotrophic lateral sclerosis, before submitting a Biologics License Application for the same.

However, the recommendation does not prevent Brainstorm from proceeding with a BLA submission for NurOwn, the regulatory agency noted.

Chaim Lebovits, CEO Brainstorm Cell Therapeutics, said, " We will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision."

The NurOwn phase III amyotrophic lateral sclerosis trial has not met statistical significance in the primary efficacy endpoint. However, according to the company, pre-specified analyses suggest that NurOwn has a clinically meaningful treatment effect.

A phase II trial evaluating NurOwn as a treatment for adults with progressive multiple sclerosis is ongoing, with top-line data expected by the end of the first quarter 2021.

BCLI closed Monday's trading at $4.58, down 33.62%.

2. Celsion Jumps On Fast Track designation For GEN-1

Shares of Celsion Corp. (CLSN) jumped more than 47% in Monday's trading, following the receipt of Fast Track designation from the FDA for its investigational drug GEN-1.

GEN-1 is a DNA-mediated interleukin-12 (IL-12) immunotherapy currently in phase II development for the treatment of advanced ovarian cancer, dubbed OVATION 2.

In the phase I part of OVATION 2 study, seven out of eight patients (88%) in the GEN-1 treatment arm had a complete tumor resection compared to 50% complete tumor resection rate in the NACT-only treatment arm. NACT refers to standard-of-care neoadjuvant chemotherapy and is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.

In a phase 1b dose-escalation trial of GEN-1, dubbed OVATION I, 100% of patients in high-dose cohorts experienced a complete or partial response, and 67% of patients in lower-dose cohorts experienced a complete or partial response.

CLSN closed Monday's trading at $2.81, up 47.89%.

3. Clene to Report Updated Data from REPAIR-MS, VISIONARY-MS Trials On Feb.25

Clene Inc. (CLNN) touched a new 52-week high of $14.60 in intraday trading Monday, as the company gears up to present updated interim data from its REPAIR-MS study and updated blinded interim data from its VISIONARY-MS study on Feb.25.

REPAIR-MS is a phase II study evaluating the company's lead nanocatalytic therapy, CNM-Au8, for the treatment of Multiple Sclerosis. The objective of the open-label, investigator-blinded REPAIR-MS study is to demonstrate improvements in brain bioenergetic metabolism in multiple sclerosis patients treated with CNM-Au8.

VISIONARY-MS is a phase II study of CNM-Au8 in patients with stable relapsing multiple sclerosis who have chronic optic neuropathy.

CLNN closed Monday's trading at $13.79, up 1.32%.

4. Otonomy Fails To Hit the Right Note

Shares of Otonomy Inc. (OTIC) plunged over 44% on Monday, following disappointing results from a phase III clinical trial of OTIVIDEX in patients with Ménière's disease.

Ménière's disease is a disorder of the inner ear that is characterized by episodes of feeling like the world is spinning (vertigo), ringing in the ears (tinnitus), hearing loss, and fullness in the ear.

According to the results reported today, the trial did not achieve the primary endpoint.

OTIC closed Monday's trading at $3.00, down 44.34%.

5. Stocks That Gained/Lost the Most in A Day

Aesthetic Medical International Holdings Group Limited (AIH) closed Monday's (Feb.22, 2021) trading at $9.25, up 32.52%.

Burning Rock Biotech Limited (BNR) closed at $39.58, up 25.33%.

Corvus Pharmaceuticals, Inc. (CRVS) closed at $4.57, up 21.54%.

Fulgent Genetics, Inc. (FLGT) closed at $105.42, down 20.75%.

Lucira Health Inc. (LHDX) closed at $24.14, down 20.38%.