Two New Studies Show Gallium-Containing Compounds Significantly Increase Bone Strength in Standard Models of Osteoporosis
12 Januar 2010 - 2:04PM
Business Wire
Genta Incorporated (OTCBB: GETA) today announced publication of
two scientific studies that test the active ingredient in Genta’s
program to develop orally available gallium-containing compounds
and the Company’s marketed product, Ganite® (gallium nitrate for
injection). In these studies, a compound containing the active
ingredient was tested in a widely accepted animal model of
established osteoporosis. The new data show that extended treatment
with the active ingredient significantly increased bone volume and
calcium content in animals with induced osteoporosis. In addition,
the increase in new bone formation was associated with a
significant restoration of bone strength back to normal levels.
Previous studies have shown that extended in vivo treatment with
low-dose gallium in normal animals was associated with increased
bone content of calcium and phosphorous, a decrease in bone
resorption, a possible increase in new bone formation, and no
deleterious effects upon bone biomechanical strength. Moreover,
preliminary clinical studies in patients with bone involvement from
myeloma, breast cancer, and other malignant diseases had shown
biochemical evidence of decreased resorption and increased bone
density. Decreased bone resorption has also been reported in
patients with advanced Paget’s disease, a metabolic bone disorder.
However, no studies have previously examined whether these effects
could be replicated in osteoporosis, the most prevalent metabolic
bone disease.
In the new studies, a model that simulates post-menopausal
osteoporosis was used to induce bone loss. The active ingredient
was administered for 8 weeks in an inorganic form (similar to
Ganite®) and also in an organic form (comparable to the Company’s
orally available gallium-containing compounds). Micro-CT scanning
showed that treatment significantly increased both trabecular and
cortical bone volume by 49% and 32%, respectively. These findings
were confirmed by histomorphometry. Additional analysis revealed a
significant increase in bone calcium content. Since some drugs used
for clinical treatment of osteoporosis (including certain
bisphosphonates) are associated with a decrease in bone strength,
biomechanical studies were performed in order to assess the quality
of the newly formed bone. These studies showed that bone from
treated animals had been restored to levels that were both fully
comparable to normal controls and significantly superior to
untreated osteoporotic controls.
Together, these new data confirm that – in osteoporotic bone –
gallium treatment is associated with significant increases in bone
mineral content, bone volume, and new bone formation that is
biomechanically normal – findings that had been previously
described only in bone that was normal at baseline. These data
strongly suggest that gallium-containing compounds exert
anti-resorptive and anabolic effects on bone metabolism, and that
such compounds may be broadly useful for a wide spectrum of
bone-losing disorders.
Abstracts of these reports can be accessed at the following
links:
http://www.ncbi.nlm.nih.gov/pubmed/19578822?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=2;
http://www.ncbi.nlm.nih.gov/pubmed/19652924?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1.
About Genta
Genta Incorporated is a biopharmaceutical company with a
diversified product portfolio that is focused on delivering
innovative products for the treatment of patients with cancer. Two
major programs anchor the Company’s research platform:
DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen
sodium) Injection is the Company's lead compound from its DNA/RNA
Medicines program. Genasense® is being developed as an agent that
may enhance the effectiveness of current anticancer therapy. The
Company is currently collecting long-term followup data on durable
response and overall survival from its recently completed
randomized Phase 3 trial of Genasense® in patients with advanced
melanoma. The leading drug in Genta’s Small Molecule program is
Ganite® (gallium nitrate injection), which the Company is
exclusively marketing in the U.S. for treatment of symptomatic
patients with cancer related hypercalcemia that is resistant to
hydration. The Company has developed proprietary oral formulations
of the active ingredient in Ganite®, which have completed
preliminary clinical trials, as a potential treatment for diseases
associated with accelerated bone loss. The Company is developing
tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is
in the same class of drugs as paclitaxel and docetaxel. Genta
intends to evaluate the clinical activity of tesetaxel in a range
of human cancers. Ganite® and Genasense® are available on a
“named-patient” basis in countries outside the United States. For
more information about Genta, please visit our website at:
www.genta.com.
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