# Therapeutic Development of Osteogenic Oxysterol, Oxy133, for Spine Fusion

> **NIH NIH R44** · MAX BIOPHARMA, INC. · 2021 · $855,153

## Abstract

ABSTRACT
Spine fusion is often the procedure of choice for various spine conditions, including degenerative spine, trauma,
tumors and deformities. The goal of the procedure is to bridge the defect by filling the void and promoting
bone regeneration. Pseudarthrosis is one of the major challenges in spine fusion, with a reported incidence of
5-35%, and requires further surgical intervention to correct the defect. Improvements in spine operative
techniques, instrumentations, grafting materials, and understanding of bone biology have contributed to better
outcomes, however, the challenge of achieving 100% fusion remains an unmet medical need. The discovery
of BMP2 as a potent bone growth factor and the development of rhBMP2 for achieving 100% fusion rates led
to its FDA approval for ALIF in 2002. However, its use has since been expanded to other procedures including
posterior lumbar spine fusion and cervical spine fusion. Unfortunately, significant life-threatening adverse
effects of rhBMP2 have been reported including soft tissue edema and inflammation associated with its use in
cervical spine that can lead to airway compromise and dysphagia. Other drawbacks of using rhBMP2 have
been noted such as its high cost, inferior quality of the new bone that often contains a large number of
adipocytes, bone resorption and osteolysis, and heterotopic bone formation. There is a need for an alternative
to rhBMP2 that would be equally or more efficacious in stimulating bone formation but with a more favorable
safety profile and lower cost.
We previously reported that Oxy133, a potent semi-synthetic proprietary osteoinductive oxysterol, robustly
stimulates osteogenic differentiation of osteoprogenitor cells, including mesenchymal stem cells, in vitro and
induces robust bone formation in animal models of localized bone formation including spine fusion and
maxillofacial and cranial bone regeneration in rats and rabbits. These activities of Oxy133 were shown to be
equal or superior to those of rhBMP2 without any apparent adverse effects such as adipogenesis, infiltration of
inflammatory cells in the fusion mass, and heterotopic bone formation. Oxy133 production is highly scalable
and much less expensive than rhBMP2 and it can be delivered as a drug-device combination via a collagen
sponge in the operating room following the same protocols as for rhBMP2 (Infuse). To continue the
therapeutic development of Oxy133 for spine fusion, in this direct to Phase 2 SBIR application, we propose
studies including formulation optimization, efficacy testing, and IND-enabling safety and toxicology studies
based on FDA guidelines for a Class III drug-device combination. Given the known features and qualities of
Oxy133 as a small molecule osteoinductive oxysterol, its successful development will provide orthopedic
surgeons and neurosurgeons a safer and more efficacious alternative to rhBMP2 for performing spine fusion in
their patients.

## Key facts

- **NIH application ID:** 10256352
- **Project number:** 1R44AR079335-01
- **Recipient organization:** MAX BIOPHARMA, INC.
- **Principal Investigator:** FARHAD PARHAMI
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $855,153
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256352

## Citation

> US National Institutes of Health, RePORTER application 10256352, Therapeutic Development of Osteogenic Oxysterol, Oxy133, for Spine Fusion (1R44AR079335-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10256352. Licensed CC0.

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