Novel Oral Tablet Option For the treatment of Bone Diseases

Implications: As a pharmaceutical consultant, I think this IND will be novel groundbreaking treatment option for the treatment of bone diseases because it is one of first oral tablet formulation that enables oral absorption of gallium nitrate injection for treatment of cancer-related hypocalcaemia. Also this is unique collaboration of two different type drug discovery (Genta) & drug delivery companies (Emisphere). Both companies are similar size and active partner for this product. Phase 1 clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects. I am hopeful that this oral tablet will be safe and effective since the active ingredient in G4544 has already demonstrated proof-of-concept activity in patients with multiple indications, including non-Hodgkin’s lymphoma, bone metastases, Paget’s disease, and osteoporosis.

Analysis:

Recently Emisphere & Genta announced the submission of IND (Investigational New Drug Exemption) for new drug known as G4544, Developed out of a joint collaboration announced last year.

G4544 is a new tablet formulation that enables oral absorption of the active ingredient contained in Ganite® (gallium nitrate injection), a drug that is marketed by Genta and approved in the U.S. for treatment of cancer-related hypercalcemia that is resistant to hydration.

Phase 1 clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects. Genta will act as Sponsor of the IND and will direct the clinical development program.

Overall, I think this IND will be novel groundbreaking treatment option for the treatment of bone diseases because it is one of first oral tablet formulation that enables oral absorption of gallium nitrate injection for treatment of cancer-related hypocalcaemia.

Also this is unique collaboration of two different type drug discovery (Genta) & drug delivery companies (Emisphere). Both companies are similar size and active partner for this product.

I am hopeful that this oral tablet will be safe and effective since the active ingredient in G4544 has already demonstrated proof-of-concept activity in patients with multiple indications, including non-Hodgkin’s lymphoma, bone metastases, Paget’s disease, and osteoporosis.