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 - for the treatment of inherited platelet dysfunction disorders (IPDDs), a distinct group of rare diseases caused by genetic mutations affecting platelet function. IPDDs are rare and present from birth, often involving lifelong bleeding tendencies. Common IPDDs include Glanzmann’s thrombasthenia, Bernard-Soulier syndrome, Hermansky-Pudlak syndrome, and Wiskott-Aldrich syndrome. These conditions usually manifest as mucocutaneous bleeding, such as nosebleeds, gum bleeding, and easy bruising; however, more severe bleeding associated with menses, childbirth, surgery and trauma forces many to seek treatment for their disorder for the first time. Diagnosis often involves genetic testing and specialized platelet function tests. Treatment can include preventive measures, platelet transfusions, pharmaceutical alternates and, in severe cases, hematopoietic stem cell transplantation. The side effects, efficacy limitations and availability challenges of these treatments in this fragile population create a significant unmet need for a safe, effective, available hemostatic solution to serve this orphan and pediatric population; CLPH-291 can be that solution. Notably, traditional platelet transfusions are to be avoided in these populations as approximately one third of IPDD recipients develop clinical and immunologic refractoriness resulting from alloimmunization.  In total, each IPDD has an incidence estimated at 1: 1,000,000 and a total combined prevalence of approximately 34,000 people in the United States.

CLPH-251 - Brain Hemorrhage 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.
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