Hemostasis

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 - is a systemic hemostatic agent being developed for the treatment of uncontrolled perioperative bleeding to be used alone or as an adjunct.  CLPH-211 may be used to treat active platelet-related or diffuse microvascular bleeding.

• CLPH-211 has recently been studied in a Danish investigator-led clinical trial in emergent, major surgical bleeding (Acute Aortic Dissection, NCT05771831). This feasibility and safety trial demonstrated CLPH-211’s hemostatic potential in a major bleed with no new safety signals.
• FPH, is ideally suited for perioperative bleeding due to the fast-acting efficacy, rapid preparation, and ability to be infused regardless of recipients blood type when time is critical.
• We are planning to develop our first-in-class hemostatic agent to stop bleeding in the presence of anticoagulants and anti-platelet drugs. 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.  Preliminary data supports hemostasis in the presence of platelet COX-1 antagonists (aspirin, NSAIDS), P2Y12 antagonists (clopidogrel) and GPIIb/IIIIa antagonists(abciximab).
• Health and Human Services (BARDA) and Department of Defense (Army) have supported Cellphire’s efforts thus far.

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.

• CLPH-251 is being developed for the treatment of Traumatic Brain Injury (TBI) with acute hemorrhage and spontaneous acute Intracerebral Hemorrhage (sICH). CLPH-251 has the potential to stop hemorrhage, prevent hematoma volume expansion and secondary injury and restore the vascular flow. There are currently no approved treatment options for TBI with acute hemorrhage or spontaneous ICH.
• CNS hemorrhage is the most dangerous form of bleeding with the highest rate of residual disability or mortality. TBI leads to major brain anatomopathological damage underlined by neuroinflammation, oxidative stress injury and progressive neurodegeneration ultimately leading to motor and cognitive deterioration. According to the CDC (2021), there were 2.9mm TBI ED visits, hospitalizations, and deaths in the U.S.
• Spontaneous Intracerebral Hemorrhage or hemorrhagic stroke primarily causes brain damage from mass effects with disruption of brain parenchyma and secondary injury results from neuroinflammation. The use of anticoagulant/antiplatelet medication increases the risks. About 10-20% of all strokes are hemorrhagic strokes. There are approximately ~76k hospitalizations per year in the U.S. Cellphire holds several Global and US patents with several others pending for the FPH Platform.