CANF Making Big Move, TGTX And FDA On The Same Page For CLL Trial, APRI On Watch

(RTTNews) - Advaxis Inc.'s (ADXS) product candidate Axalimogene filolisbac has shown 38.5% 12-month overall survival rate in 26 patients with persistent/recurrent metastatic cervical cancer in Stage 1 of an ongoing two-stage phase II study. The Stage 1 protocol provided for 3 doses of Axalimogene filolisbac over 3 months.

The Stage 2 of the phase II study is currently enrolling and its protocol allows for continuous cycles of treatment until disease recurrence.

The company's request to the FDA for a Special Protocol Assessment for a phase III study evaluating the safety and efficacy of Axalimogene filolisbac in high-risk, locally advanced cervical cancer is under review.

ADXS closed Thursday's trading at $19.71, up 0.41%.

Apricus Biosciences Inc.'s (APRI) phase 2a trial of RayVa in patients with scleroderma who also suffer from Raynaud's phenomenon has demonstrated that there were no significant safety or tolerability issues observed in any dosing cohort.

Raynaud's phenomenon is characterized by vasoconstriction of the hands and feet in response to cold or stress resulting in reduced blood flow and the sensation of pain, which can be severe.

The primary objective of the phase 2a trial was to establish safety and tolerability of of RayVa and to look for pharmacodynamic effects in the targeted Raynaud's population.

Apricus intends to move RayVa into a later stage phase 2 clinical trial in 2016. This clinical trial will be designed to assess safety and efficacy in an at-home dosing setting evaluating a symptomatic response to the treatment of an acute episode.

APRI closed Thursday's trading at $1.58, up 1.94%.

Shares of Can-Fite BioPharma Ltd. (CANF) surged more than 95% on Thursday, following the FDA's Fast Track designation for the company's drug candidate CF102 as a second line treatment for hepatocellular carcinoma, the most common form of liver cancer.

CF102 had already received the FDA's Orphan Drug designation, and is under a phase II study for hepatocellular carcinoma in the U.S., Europe and Israel. The study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar.

CANF surged 95.24% on Thursday to close the day's trading at $3.28. In after-hours, the stock was up another 20.73% to $3.95.

Cumberland Pharmaceuticals Inc. (CPIX) has agreed to a strategic alliance with Clinigen Group plc, which is expected to create a new growth driver for both companies.

The alliance will provide Cumberland Pharmaceuticals' access to new international markets and strengthen Clinigen's North American footprint.

CPIX closed Thursday's trading at $6.01, up 0.17%.

Cynosure Inc. (CYNO) has received clearance from the China Food and Drug Administration to market the PicoSure 755 nm wavelength for tattoo removal.

The 755 nm PicoSure wavelength received FDA clearance in the U.S. in the fourth quarter of 2012 for the removal of tattoos and benign pigmented lesions, and was subsequently cleared for marketing in Canada, Australia, Korea and Taiwan.

CYNO closed Thursday's trading at $34.75, down 1.81%.

Sequenom Laboratories, a wholly owned subsidiary of Sequenom Inc. (SQNM), has announced a national coverage agreement with UnitedHealthcare Insurance Co. for prenatal diagnostic testing services.

The agreement, which will become effective October 1, 2015, covers 43 million people throughout the United States, and the prenatal diagnostic testing services that will be covered include, the MaterniT21 PLUS, HerediT CF Carrier Screen and HerediT UNIVERSAL Carrier Screen laboratory-developed tests (LDT).

The addition of this new contract brings the number of covered lives under agreement by Sequenom Laboratories' diagnostic services to more than 200 million, added the company.

SQNM closed Thursday's trading at $2.44, up 17.87%.

Shares of TG Therapeutics Inc. (TGTX) were up more than 22% on Thursday after the company announced a Special Protocol Assessment agreement with the FDA for the first phase III trial of its proprietary combination regimen of TG-1101 and TGR-1202 for patients with chronic lymphocytic leukemia.

Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies.

TGTX closed Thursday's trading 22.61% higher at $14.37.