Next generation anti-cancer drugdelivering cement for bone metastasis patients

Abstract Our mission is to develop an innovative anti-cancer drug delivering bone cement for bone metastasis patients, which can be injected into metastasis-caused bone degeneration sites in a minimally invasive manner, to regress cancer, regenerate bone, and stop the pain. Metastasis is the main cause of cancer death. Bone is one of the most frequent cancer metastatic sites. About 350,000 Americans die due to bone metastasis each year. Metastasized cancer cells can extensively destroy the bone by over-activating osteoclasts. Fragilized bone easily gets fractured by simple movement, causing intolerable pain and immobility to bone metastasis patients. As a result, the life quality of bone metastasis patients is extremely poor. Bone metastasis is currently incurable. In the clinic, polymethyl methacrylate (PMMA) cement is dominantly used to instantly stabilize the metastasis-caused bone fractures of dying cancer patients to reduce their devastating pain, based on its excellent mechanical strength. However, PMMA is plexiglass that does not regenerate bone and has a high risk of serious adverse events. As cancer therapeutics are rapidly advancing, bone metastasis patients are living longer than before. Therefore, there is an urgent and unmet medical need for an advanced cement that can support the recovery of cancer patient health. To overcome the drawbacks of PMMA cement, calcium phosphate cement has been used for bone regeneration based on its similar composition to native bone. However, existing calcium phosphate cement products burst release drugs and none of them received FDA approval for drug delivery purposes. To solve this important medical problem, we aim to develop a paradigm-shifting “healing cement” that can deliver anti-cancer drugs and regenerate bone by using innovative whitlockite material. Whitlockite is the second most abundant bone mineral in the human body, which exists with a higher ratio in younger aged people and earlier stage of mineralization. Our team has developed a large scale, facile synthetic method of whitlockite and showed its superior bone regeneration capacity and mechanical strength compared to existing calcium phosphate bone substitute products in the clinic. Recently, excitingly, we advanced the synthetic process of whitlockite and developed an injectable whitlockite-based cement. Strikingly, this advanced whitlockite-based cement could load a significantly large quantity of drugs and release them in a sustained manner. Based on this innovative invention, through this NIH STTR program, we aim to manufacture the first anti-cancer drug delivering bone cement product and translate it into the clinic to benefit bone metastasis patients. We envision that our innovative anti-cancer drug delivering whitlockite-based bone cement product will provide a breakthrough to overcome bone metastasis. We also expect this whitlockite-based bone cement will significantly reduce the side effects of anti-cancer drugs on other organs by enabling targeted therapy to the bone.