Redhill Goes Green, BTX Gets Grant, TSRO Slammed, IMUC Rallies, CANF On A High

(RTTNews) - BioTime Inc.'s (BTX) subsidiary Cell Cure Neurosciences Ltd. will be filing an IND application to commence human clinical trials of OpRegen, a cell-based therapeutic product for the treatment of age-related macular degeneration, in 2014. Cell Cure has been awarded a grant for 2014 of 6.1 million Shekels (approximately $1.74 million) from Israel's Office of the Chief Scientist to help finance the development of OpRegen.

BTX closed Monday's trading 2.33% higher at $3.52.

Can-Fite BioPharma Ltd. (CANF) touched a new high of $9.46 on Monday before closing at $8.60, following positive results from a phase IIb study evaluating its drug candidate CF101 in patients with active rheumatoid arthritis.

In the 12-week, placebo-controlled study, CF101 when administered orally twice-daily as a monotherapy, showed statistically significant superiority over placebo in reducing signs and symptoms of rheumatoid arthritis compared to the placebo.

Durata Therapeutics Inc.'s (DRTX) Marketing Authorization Application for Dalbavancin, seeking approval in the indication of complicated skin and soft tissue infections, has been accepted for review by the European Medicines Agency. The regulatory agency's decision is expected in the first half of 2015.

The FDA's decision on the New Drug Application for Dalvance (dalbavancin hydrochloride) is set for May 26, 2014.

DRTX closed Monday's trading at $12.75, up 5.72%.

ImmunoCellular Therapeutics Ltd. (IMUC) rallied over 20 percent to $1.05 in after-hours on Monday after the company announced that the first patient in a phase I clinical trial of ICT-121, a cancer vaccine targeting recurrent glioblastoma multiforme (GBM, or brain cancer), has received the vaccine.

The phase I trial is an investigator-sponsored study, being conducted at Cedars-Sinai Medical Center in Los Angeles, CA.

ImmunoCellular shares took a hit on Dec.12, 2013, plunging nearly 60 percent to $1.10, as a phase II study of ICT-107 in patients with newly diagnosed glioblastoma multiforme failed to achieve statistical significance in the primary endpoint of overall survival while the progression-free survival showed a statistically significant advantage over placebo.

RedHill Biopharma Ltd. (RDHL) said that results from a pharmacokinetic study with RHB-105, a proprietary combination therapy, oral capsule formulation, for eradication of Helicobacter pylori (H. pylori) infection, a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma, are positive.

The pharmacokinetic study supports the continuation of a phase III clinical study currently underway in the U.S., evaluating RHB-105 as a first-line therapy for H. pylori bacterial infection. The study, dubbed ERADICATE Hp, was initiated recently, and data is expected to be available by the third quarter of 2014.

RDHL closed Monday's trading 4% higher at $10.25.

Resverlogix Corp. (RVX.TO) said that its exploratory phase II clinical trial of RVX-208 in patients with pre-diabetes mellitus has completed enrollment of twenty patients. The company expects data from this trial in mid-2014.

Supernus Pharmaceuticals Inc. (SUPN) rose more than 18 percent to $8.75 in extended trading on Monday as the company is set to receive certain milestone fees and royalties associated with the commercialization of its partner product Orenitram Extended-Release Tablets from United Therapeutics Corp. (UTHR).

United Therapeutics' Orenitram Extended-Release Tablets, which received FDA approval for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity on Dec.20, 2013, utilizes Supernus' advanced osmotic technology EnSoTrol that is designed to deliver unique release profiles and to address specific challenges in oral delivery.

TESARO Inc. (TSRO) crashed nearly 25% to $28.37 on Monday following mixed results from two phase III trials of its drug candidate oral Rolapitant for the prevention of chemotherapy-induced nausea & vomiting. While the two trials met the primary endpoint, they failed to achieve statistical significance in secondary endpoints.

Nausea and vomiting are among the most distressing side effects of chemotherapy treatment for a majority of cancer patients.

One of the phase III trials evaluated oral Rolapitant in cancer patients receiving highly emetogenic chemotherapy (HEC) and the other in cancer patients receiving moderately emetogenic chemotherapy (MEC).

The third phase III trial of oral Rolapitant in patients receiving HEC is also underway, with enrollment expected to conclude at year end. The company expects top-line results from this study to be available in early 2014.

If all goes well as planned, the company expects to submit a NDA for oral Rolapitant in mid-2014.