CBMG On Track, NAVB Chugs Along, Nuvo Gets Decision Date, VICL Trims Staff

(RTTNews) - Cellular Biomedicine Group (CBMG) has completed patient enrollment for its phase I trial of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy in liver cancer. The company noted that it is on track to complete the phase I trial in the fourth quarter of this year.

CBMG.OB closed Thursday's trading at $6, unchanged from the previous day's close.

Navidea Biopharmaceuticals Inc. (NAVB) has reached agreement with FDA on Special Protocol Assessments for its pivotal phase III program with NAV5001, an investigational radiopharmaceutical imaging agent. NAV5001 is being developed as an aid in the differential diagnosis of Parkinsonian syndromes.

The company is actively preparing for the initiation of the pivotal phase III trials for NAV5001 later this year.

NAVB closed Thursday's trading at $2.96, up 3.14%.

Nuvo Research Inc. (NRI.TO) said that the NDA for pain product PENNSAID 2% submitted by its business partner Mallinckrodt (MNK) on August 7, 2013 has been accepted for review by FDA. The regulatory decision is expected by February 7, 2014.

PENNSAID 2% is an improved version of Pennsaid, a non-steroidal anti-inflammatory drug, approved to treat signs and symptoms of osteoarthritis of the knee.

This is the second time that PENNSAID 2% faces FDA review. Mallinckrodt was issued a complete response letter for PENNSAID 2% in March of this year and was required to the complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID. The resubmitted NDA included data from the pharmacokinetic study too.

NRI.TO lost 10.11% on Thursday to close at C$1.69.

Nymox Pharmaceutical Corp.'s (NYMX) investigational drug for benign prostatic hyperplasia NX-1207 has had no significant safety concerns to date in NX02-0018 clinical trial, one of the two phase III trials, according to a recent review by Safety Monitoring Committee.

The two phase III trials of NX-1207 have completed enrollment and treatment and patient evaluation is continuing at over 70 well-known urology investigative sites across the U.S., said the company.

NYMX closed Thursday's trading 5.07% higher at $7.04.

OncoMed Pharmaceuticals Inc. (OMED), which became a public company as recently as July 18, has been issued a patent for methods of treating cancer with its investigational antibody Vantictumab (OMP-18R5). The patent expires in 2029.

Vantictumab targets and inhibits the Wnt pathway, which is believed to be an important CSC pathway. Vantictumab is currently being evaluated in a phase 1 clinical trial.

OMED closed Thursday's trading at $16.65, up 1.77%.

Vical Inc. (VICL), which recently suffered a pipeline setback when its investigational cancer immunotherapy Allovectin failed to meet its phase III efficacy endpoints, has decided to restructure the organization in order to conserve capital.

Accordingly, the company will reduce its staff headcount by 47 employees or approximately 39% of the company's total workforce. Following the restructuring, the company will have about 74 employees. Vical has also decided to terminate activities related to Allovectin.

VICL closed Thursday's trading at $1.33, up 0.76%.