Clinical Research

Keryx Biopharmaceuticals, Inc. has announced the initiation of a Phase 2 study of Zerenex (ferric citrate), an ferric iron-based phosphate binder drug candidate, in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease ("NDD-CKD").

In the United States alone, over one and a half million people suffering from Stages 3 to 5 NDD-CKD have iron deficiency anemia, however, there are currently no oral iron supplements with an FDA label in NDD-CKD. Also, there are currently no FDA approved phosphate binders in NDD-CKD.

Glybera is the first gene therapy approved by regulatory authorities in the Western world. niQure announced it has received approval from the European Commission for the gene therapy Glybera(R) (alipogene tiparvovec), a treatment for patients with lipoprotein lipase deficiency (LPLD, also called familial hyperchylomicronemia) suffering from recurring acute pancreatitis.

Patients with LPLD, a very rare, inherited disease, are unable to metabolize the fat particles carried in their blood, which leads to inflammation of the pancreas (pancreatitis), an extremely serious, painful, and potentially lethal condition. The approval makes Glybera the first gene therapy approved by regulatory authorities in the Western world. 

A neuroprotectant drug has been shown to protect the human brain against the damaging effects of stroke. The clinical trial was a randomized, double blind, multi-center trial that was conducted in Canada and the USA. The study evaluated the effectiveness of NA-1 (Tat-NR2B9c) when it was administered after the onset of small strokes that are incurred by patients who undergo neurointerventional procedures to repair brain aneurysms. This type of small ischemic stroke occurs in over 90% of aneurysm patients after such a procedure, but usually does not cause overt neurological disability. 

 Apollo Hospitals performed a complex spinal surgery on a 10-year-old child, the 12th successful surgery done within 10 days of the launch of Renaissance Robotic Technology, the only technology specifically designed for spine surgery. Apollo Hospitals Group is the first in the Asia-Pacific to offer this surgical guidance system, which is a minimally-invasive robotic-guided spine surgery. 

A 10-year-old girl from Gujarat, Heema was born with congenital anomalies that left her with a severely deformed spine. Before being admitted to Apollo Hospitals, the child had already undergone multiple procedures that had failed and left her with rods placed in her back, broken at multiple places, and a spine that was grotesquely deformed.

Obesity is not just happening in New York City 7-Elevens(1), it is also happening in aging bones.

Bone marrow stem cells, which are adult stem cells, are in their fifth decade of uncontroversial new discovery. But they can still surprise us.  Our bones may be getting fatter as we age, and it could lead to osteoporosis, the condition where bone mineral density is 2.5 standard deviations below the mean (62%). The NIH estimates that up to 50% of women and 25% of men over the age of 50 will break a bone due to osteoporosis. 

A large study published in Human Reproduction (1) looked at the effect of induced abortions on a subsequent first birth and found that women who have had three or more abortions have a higher risk of adverse birth outcomes, such as delivering premature and low birth weight babies.

Oxford BioMedica plc biopharmaceuticals and its partner Sanofi announced a positive interim review of the RetinoStat(R) Phase I study in neovascular "wet" age-related macular degeneration (AMD) and the StarGen(TM) Phase I/IIa study in Stargardt disease by the Data Safety Monitoring Board (DSMB); an independent panel of specialists in the fields of ophthalmology, virology and vectorology. RetinoStat(R) and StarGen(TM) were designed and developed by Oxford BioMedica using the Company's proprietary LentiVector(R) gene delivery technology.