FDA Lifts Hold On CVM's Study, FATE On Track, REGN, OPHT, ZYNE All Flunk Trials

(RTTNews) - Today's Daily Dose brings you news about CEL-SCI's resumption of Multikine trial; Fate Therapeutics' progress with its pipeline; Lipocine's regulatory catalyst to watch out for; Omeros' stock offering; Ophthotech's disappointing results from wet AMD trial; Regeneron's failed respiratory syncytial virus trial and Zynerba's osteoarthritis trial results.

Read on...

Shares of CEL-SCI Corp. (CVM) jumped more than 29% on Monday, following news that the FDA has lifted the clinical hold on the Company's phase III clinical trial of Multikine in advanced primary head and neck cancer.

The FDA had imposed the clinical hold on the study last September. Now that the clinical hold has been lifted, all clinical activities will resume.

The study's primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus standard of care (SOC) versus those who receive SOC only. Current SOC for primary head and neck cancer is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy.

CVM closed Monday's trading at $3.00, up 29.87%.

Fate Therapeutics Inc. (FATE) is making good progress with its pipeline.

The Company plans to initiate enrollment in its phase II efficacy stage of PROTECT study next month.

PROTECT is a phase 1/2 clinical trial of ProTmune in adult subjects with hematologic malignancies undergoing matched unrelated donor mobilized peripheral blood HCT. The PROTECT study is intended to evaluate ProTmune to prevent acute graft-versus-host disease (GvHD).

The Company has convened the Data Monitoring Committee to review the phase I safety stage of PROTECT.

A phase I study of FATE-NK100, the Company's first-in-class adaptive memory natural killer (NK) cell product candidate for advanced acute myeloid leukemia is underway.

The Company looks forward to initiating a phase I trial of FATE-NK100 for the treatment of women with ovarian cancer resistant to, or recurrent on, platinum-based treatment, and another phase I study of FATE-NK100, including in combination with monoclonal antibody therapy, in subjects with advanced solid tumor malignancies.

FATE closed Monday's trading at $3.09, up 3.69%. In after-hours, the stock was up 13.59% to $3.51.

Lipocine Inc.'s (LPCN) resubmitted New Drug Application seeking approval of TLANDO as testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism, has been accepted for review by the FDA - with a decision date set for February 8, 2018.

TLANDO was issued a complete response Letter by the FDA last June, citing deficiencies related to the dosing algorithm for the label.

LPCN closed Monday's trading at $4.32, up 1.17%.

Shares of Omeros Corp. (OMER) were down over 6% in extended trading on Monday after the Company announced that it has commenced a registered underwritten public offering of 3 million shares of its common stock.

In addition, Omeros has granted the underwriter a 30-day option to purchase up to 450,000 additional shares of its common stock.

OMER closed Monday's trading at $24.61, up 4.95%. In after-hours, the stock was down 6.34% to $23.05.

Ophthotech Corp.'s (OPHT) phase III clinical trial of Fovista for the treatment of wet age-related macular degeneration, dubbed OPH1004, has not met the pre-specified primary endpoint.

In OPH1004, Fovista in combination with Eylea or Avastin compared to Eylea or Avastin monotherapy did not meet the pre-specified primary endpoint of mean change in visual acuity at 12 months.

According to the trial results, subjects receiving Fovista in combination with Eylea or Avastin therapy gained a mean of 9.42 letters of vision on the ETDRS standardized chart at 12 months, compared to a mean gain of 9.04 ETDRS letters in patients receiving Eylea or Avastin monotherapy.

Last December, two pivotal Phase 3 clinical trials investigating the superiority of Fovista therapy in combination with Lucentis compared to Lucentis monotherapy for the treatment of wet AMD failed to meet the primary endpoint.

OPHT closed Monday's trading at $2.71, up 6.27%.

Regeneron Pharmaceuticals Inc.'s (REGN) phase III study of Suptavumab for respiratory syncytial virus has failed to meet its primary endpoint of preventing medically-attended RSV infections in infants.

Respiratory syncytial virus (RSV) is the most common cause of infections of the lower respiratory tract and is the world's primary viral cause of serious diseases of the lower respiratory tract in infants and young children.

The Company has decided to discontinue further clinical development of Suptavumab.

REGN closed Monday's trading at $474.54, up 1.70%.

Barely a week after reporting disappointing results from its epilepsy trial, Zynerba Pharmaceuticals Inc. (ZYNE) has suffered yet another setback.

The Company's phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP, has not met its primary endpoint.

The primary endpoint was reduction from baseline in the weekly mean of the 24-hour average worst pain score at week 12, which was not met. However, statistically significant results were achieved for a number of secondary endpoints.

On August 7, 2017, the Company announced that its phase II study of ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures, dubbed STAR 1, did not meet the primary endpoint. The news sent the stock tumbling over 55% to $6.61 that day.

ZYNE closed Monday's trading at $6.42, down 8.68%. In after-hours, the stock was down 1.87% to $6.30.