Advinus Therapeutics, a research-based
pharmaceutical company promoted by the Tata Group, has announced the
discovery of a novel molecule, GKM-001, for the treatment of type 2
diabetes. The molecule is an activator of glucokinase; an enzyme that
regulates glucose balance and insulin secretion in the body.
GKM-001 is completely indigenously developed molecule, and the initial
clinical trials have shown excellent results for both safety and
GKM-001 is a novel molecule for the treatment of type 2 diabetes. It is
the first glucokinase modulator discovered and developed in India. The
success in discovering GKM-001 is attributed to the science-driven
efforts in Advinus laboratories, and “breaking the conventional mold”
for selection of a drug candidate. Advinus has “Composition of Matter”
patent on the molecule for all major markets globally. Glucokinase as a
class of target, is considered to be novel, as currently there is no
product in the market, or in late clinical trials. The strategy for
early clinical development revolved around assessing safety
(particularly hypoglycemia); and early assessment of therapeutic
activity (glucose lowering and other biomarkers) in type 2 diabetics.
The phase I data, in both healthy and type 2 diabetics, shows excellent
safety and tolerability over a 40-fold dose range, and desirable
pharmacokinetic properties consistent with ‘once-a-day’ dosing. The
next wave of clinical studies planned, continues on this strategy of
early testing in type 2 diabetics.
Right behind the lead candidate GKM-001, Advinus has a rich pipeline of
back up compounds on the same target. These include several
structurally different compounds with diverse potency, unique
pharmacology and tissue selectivity. Having discovered the molecule
with early indication of wide safety margins, desired efficacy and
pharmacokinetic profiles, the company now seeks to out-license
GKM-001 and its discovery portfolio.
Neeman expands therapeutic trial
Max Neeman International, a full service clinical research organization
headquartered in New Delhi, has expanded therapeutic-focused clinical
trial services in India. Max Neeman has formed a world class team of
medical device experts, specializing in carrying out cardiac device
trials – therapeutic, diagnostic and surgical.
Along with prior experience in conducting device trials, the
specialized Max Neeman team and services adds an enhanced level of
company expertise, in conducting simple to complex device studies. Max
Neeman has medical device operations and regulatory experience in
various other device therapeutic areas as well, including central
nervous system and ophthalmology.
India is emerging as a destination of choice for medical device
development and conducting device trials, as the market for
percutaneous coronary interventions has expanded. India’s medical
device market is currently valued at
crore ($1.7 billion); and is projected to grow at the rate of 23
Biocon, a leading biotechnology company in India, has entered into an
agreement with Teleradiology Solutions, for getting teleradiology
reporting services to Clinigene, its clinical research organization.
Teleradiology Solution’s quality-driven reporting process and
technology platform benefits biotechnology and pharmaceutical
companies; and it also eliminates delays in the completion of clinical
trials, by optimizing the radiology reporting process.
Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said,
“To achieve our main objective of accelerating clinical research, we
rely on an adept mix of technology, experience and personal traits.
Keeping in line with our mission, Teleradiology Solutions, was the
partner of choice to meet our complex image analysis requirements. The
signing of this agreement further endorses Bangalore as the hub of
excellence, both in biotechnology as well as in high-end healthcare
delivery to the world.”
Dr Arjun Kalyanpur, managing director and chief radiologists,
Teleradiology Solutions, said, “For pharmaceutical and biotechnology
companies involved in drug development R&D, delays in the drug
development cycle can be an issue of concern. These are, in part,
related to delays in reporting of radiologic scans that are performed,
to confirm that the patient under treatment has responded positively to
the drug being evaluated in the clinical trial. The delays are, in
turn, related to the worldwide shortage of radiologists, estimated to
be as high as 20 percent in some studies.”