FPH Technology
The FPH pipeline consists of four separate biologic products with distinct characteristics (e.g., concentration, product presentation and administration). Once approved, this suite of products will be used across the healthcare continuum from military field applications, acute bleeding treatment, brain hemorrhage treatment, bleeding treatment for orphan genetic platelet disorders.
Cellphire is developing products that can be routinely available at all levels of care and to all providers once approved by the U.S. Food and Drug Administration.
CLPH-211 - FPH used for Operating Room hemostasis, the lead FPH product program is in Phase 2 clinical trials in Denmark, and has strong pre-clinical and clinical safety data. Health and Human Services (BARDA) and Department of Defense (Army) support our efforts due to the mission fit with DoD and HHS. Trauma deaths from hemorrhage could be reduced by 36 percent, or over 50,000 saved lives, in the United States per year with balanced early transfusion of blood products, including platelets (Drake, 2020). Cellphire's product in development, FPH, is ideally suited for patients in trauma due to the fast-acting efficacy, rapid preparation, and ability to be infused regardless of recipients blood type when time is critical. There has been a significant increase in the use of these agents for primary prevention of stroke and heart disease. Patients taking these drugs are at a greater risk of bleeding from accidents or if they need emergency surgery. We are developing next generation platelet-derived products to stop bleeding in the presence of anticoagulants and anti-platelet drugs. Preliminary data supports hemostasis in the presence of platelet COX-1 antagonists (aspirin, NSAIDS), P2Y12 antagonists (clopidogrel) and GPIIb/IIIIa antagonists(abciximab).
CLPH- 291 - FPH addressing Orphan Genetic bleeding disorders has the potential to resolve platelet-related bleeding in an underserved patient population where the standard of care, apheresis platelets, either does not work or is unavailable. A product targeting orphan genetic bleeding disorders will, we believe, receive Orphan Drug/Fast Track designation and has the potential for a Priority review Voucher (PRV). PRV's are currently trading for approximately $100MM. Hermansky-Pudlak syndrome (HPS) represents a promising initial target for our FPH technology.
CLPH-251 - Brain Hemorrhage Treatment is the leading cause of mortality and disability among individuals under 40 years old and the fourth most common cause of death among elderly individuals in the Western world. Annually, approximately 1.4 million individuals incur traumatic brain injury (TBI) in the United States, with an estimated 90,000 individuals experiencing long-term disabilities. Traumatic intracerebral hemorrhage (tICH) is an important component of TBI. The rapid detection and early evacuation of hemorrhagic mass lesions has been one of the primary treatment strategies in the modern management of TBI. Surgical evacuation of tICH is usually only undertaken for large lesions (>25 ml), and considerable debate exists regarding the indications for and timing of surgery for patients with brain contusions. Therefore, a therapy that limits hemorrhagic progression in TBI is urgently needed.
This video shows Thrombosomes® (pale green mass) aggregated at the site of a cut and recruiting circulating human platelets (bright green moving particles) to create a clot and stop bleeding.
Regenerative Medicine
Cellphire is developing regenerative medicine therapeutics that have a range of potential applications. Our initial focus is treatment of osteoarthritis (OA), a disease affecting over 300 million people worldwide (Cross, 2020). The current standard of care, corticosteroids, may be associated with an increased risk of progression of the disease toward joint replacement (Zeng, 2019).
US Annual Joint Replacements: 720,000 knee + 330,000 hip = ~ $20B/year
Autologous platelet rich plasma (PRP) has shown efficacy in reducing pain and slowing the progression of OA (Boffa, 2021), but the high variability of autologous (single donor) PRP and inconsistency of composition have impeded adoption of the treatment (Magalon, 2021).
Our product has the potential to provide an easy to use off-the-shelf PRP equivalent, but with consistent quality and composition, thereby providing clear clinical data that doctors can trust.
High Resolution Imaging
Cellphire has harnessed platelets’ aggregation function in order to concentrate contrast agents at the site of internal bleeds, which are often difficult to pinpoint. We can load human platelets with contrast agents that aggregate at the bleeding site to render high resolution images. This can improve diagnostics and reduce the need for unnecessary invasive surgery to stop internal bleeding.