GreenJay Therapeutics develops a new intravenous formulation of busulfan that eliminates a toxic Class 2 solvent, reducing the risk of severe side effects for patients undergoing stem cell transplantation for hematological diseases. This reformulation aims to enhance drug solubility, improve patient tolerability, and increase physician acceptance, ultimately leading to better clinical outcomes.
Funding
Funding not disclosed
Founders
Product
Problem
Current intravenous busulfan formulations, used in stem cell transplantation for hematological diseases, contain a Class 2 solvent. The FDA recommends strict dose limits for this solvent due to its severe chemical effects, but existing busulfan formulations exceed these limits by a significant margin, potentially exposing patients to toxicity risks.
Solution
GreenJay Therapeutics is developing Bulanta™, a new intravenous formulation of busulfan that eliminates the Class 2 solvent found in current formulations. By removing this solvent, Bulanta™ aims to reduce the toxicity associated with busulfan treatment without compromising efficacy. The company is pursuing regulatory approval through the NDA 505(b)(2) pathway, initially targeting use in Chronic Myelogenous Leukemia (CML) and subsequently expanding to other cancers requiring stem cell transplants. Bulanta™ is designed to improve patient tolerability, enhance physician acceptance, and ultimately improve clinical outcomes in patients undergoing stem cell transplantation.
Target Audience
The primary target audience includes patients with hematological malignancies, such as CML, undergoing stem cell transplantation, and the physicians who treat them.
Features
- Solvent-free formulation of intravenous busulfan, eliminating the need for a Class 2 solvent.
- Designed to reduce toxicity risks associated with current busulfan formulations.
- Aims to improve patient tolerability and compliance.
- Regulatory pathway: pursuing approval through the NDA 505(b)(2) pathway.
- Initial target indication: Chronic Myelogenous Leukemia (CML).
- Potential for expanded use in other cancers requiring stem cell transplants, such as acute myelogenous leukemia (AML).