AGN's Filler Gets FDA Green Light, ADXS, CYTR On Watch, IMMU On The Move

(RTTNews) - Advaxis Inc. (ADXS) has dosed the first patient in its phase I study, dubbed REALISTIC, which is evaluating ADXS-HPV for the treatment of HPV-positive head and neck cancer.

The company's stock was uplisted to the NASDAQ Capital Market from the OTCQB on October 17th, 2013.

ADXS closed Wednesday's trading at $3.49, down 2.51%.

Allergan Inc.'s (AGN) facial aesthetic product JUVÉDERM VOLUMA XC received FDA approval to temporarily correct age-related volume loss in the cheek area in adults over the age of 21.

JUVÉDERM VOLUMA XC becomes the first and only approved filler to correct age-related volume loss in the cheek area. The product creates a more youthful appearance to the face and provides natural-looking and long-lasting results up to two years with optimal treatment, says the company.

AGN closed Wednesday's trading at $91.57, down 0.20%.

BioSpecifics Technologies Corp. (BSTC) said that the first patient in a phase IIa study of XIAFLEX for the treatment of cellulite has been dosed. Topline results from the study are expected in the first quarter of 2015.

Xiaflex is already approved in the U.S. for the treatment of adult Dupuytren's contracture, and has been available since March 2010 for that indication. The drug is also under FDA review for the proposed indication of Peyronie's disease, with a decision date set for December 6, 2013.

BioSpecifics has a development and license agreement with Auxilium Pharmaceuticals Inc. (AUXL) for Xiaflex for clinical indications in Dupuytren's contracture, Peyronie's disease, frozen shoulder and cellulite.

BSTC closed Wednesday's trading at $18.55, down 0.59%.

CytRx Corp. (CYTR) said that additional preliminary data from its phase 2b clinical trial demonstrating Aldoxorubicin's potential advantage over approved chemotherapy drug Doxorubicin in the treatment of soft tissue sarcoma will be presented at the 18th Annual Connective Tissue Oncology Society Meeting on October 31, 2013.

The company expects to report top-line data for the trial in December 2013.

CYTR closed Wednesday's trading 4.38% higher at $2.62.

Eli Lilly and Co.'s (LLY) biologics license application for Ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy has been assigned a priority review status by the FDA. Therefore, the regulatory agency's decision on Ramucirumab can be announced in the second quarter of 2014.

LLY closed Wednesday's trading at $50.31, up 0.32%.

Immunomedics Inc. (IMMU) rose more than 12 percent to $4.59 on Wednesday after the company reported that in a phase Ib trial, multiple cycles of therapy with its investigational pancreatic cancer therapeutic, Yttrium-90-labeled clivatuzumab tetraxetan, administered in combination with low-dose Gemcitabine, produced a median overall survival of more than 5 months in patients with metastatic pancreatic cancer who had received at least 2 prior treatments.

The company is planning to initiate a phase III trial with clivatuzumab in late-stage pancreatic cancer, and is preparing to open this pivotal study before the end of 2013 or the beginning of 2014.

Sucampo Pharmaceuticals Inc. (SCMP) has initiated a pivotal clinical trial of a liquid formulation of Lubiprostone in adult subjects with chronic idiopathic constipation. The trial is anticipated to end in 2014.

Lubiprostone is already approved in oral formulation, and is available under the brand name AMITIZA in the U.S. AMITIZA is indicated for the treatment of chronic idiopathic constipation in adults and opioid induced constipation in adults with chronic, non-cancer pain.

SCMP closed Wednesday's trading at $6.46, down 1.82%.