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.Narrative
The life quality of bone metastasis patients is extremely poor as metastasized tumor cells frequently fragilize the
bone, causing intolerable pain and immobility. Currently, there is no effective treatment in the clinic to cure bone
metastasis. To solve this important medical problem, we will develop next-generation cement material that can
deliver anti-cancer drugs and restore the bone health of cancer patients to recover their lives.