Advancing Therapeutics

Our Pipeline of Innovative Solutions

PP-007 Sanguinate®

Preclinical

Phase I

Phase II

Phase III

Prolong’s lead biopharmaceutical pipeline candidate is PEGylated carboxyhemoglobin bovine (PCHB). PP-007's unique mechanisms arise from its components as an acellular dual action carbon monoxide (CO) releasing molecule and an oxygen transfer agent.

Draw blood from Holstein Cows

Isolate & Purify Hemoglobin

PEGylate & Add Carbon Monoxide

PP-007 Administrable Via IV

Innovative Treatment

What is PP-007?

PP-007 (PEGylated bovine carboxyhemoglobin) is a nano-sized oxygen carrier. The PEGfinity™ process combines hemoglobin with PEG, modifying its hemoglobin saturation profile to selectively oxygenate severely hypoxic tissue.

Target Condition

Acute Ischemic Stroke

The primary indication for PP-007 is acute ischemic stroke (AIS), caused by a blood clot blocking brain blood flow, leading to hypoxia and brain injury. PP-007 aims to treat this by improving microcirculation and tissue oxygenation.

Mechanism of Action

How PP-007 Works

PP-007 selectively oxygenates hypoxic tissues, delivering targeted oxygenation to improve perfusion and reduce inflammation. This holistic approach helps achieve vascular and tissue homeostasis, addressing the root causes of ischemia and hypoxia.

How does Sanguinate® work?

Prolong’s Critical Role in Combating Stroke

Addressing a Worldwide Health Issue

It is expected to be compatible with current and future standards of care and can potentially extend treatment windows for existing and new treatments.

15M

People suffer a stroke each year.

Deaths each year from stroke.

700K

Patients eligible for treatment.

Clinical Trials

PP-007 is being developed to treat conditions of ischemia/hypoxia. It improves microvascular perfusion while promoting oxygen transfer to hypoxic cells and tissues.

HEMERA-1 (CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke) is the first clinical trial of PP-007 in acute ischemic stroke.

Preclinical Results

Prolonged ischemic shock (PIS) was studied by subjecting 17 male Sprague Dawley rats to controlled, stepwise blood withdrawal (45% by volume) to mimic conditions of post-injury progressive hemorrhage control.

Animals were maintained in a state of untreated ischemic shock for at least 60 minutes and then received a 20% hypovolemic resuscitation with one of three test solutions: a crystalloid (Lactated Ringer’s Solution; LRS), a colloid (Hextend), or SANGUINATE^®.

Using this PIS model, resuscitation with SANGUINATE^® improved metrics of survival, mean arterial pressure, and P_ISFO₂ compared to standard resuscitation fluids.

Survival was significantly different among treatment groups (p < 0.01), where LRS, Hextend, and SANGUINATE^®-treated animals survived 16 ± 3.4,76 ± 11.1 and 193 ± 33.4 mins, respectively.

Only SANGUINATE^® produced a significant rise in tissue P_ISFO₂ by two hours post-resuscitation (p < 0.01).

Mean arterial pressure was significantly increased in SANGUINATE^®vs. LRS (p < 0.05) post-resuscitation, and higher than Hextend by 60 min post-resuscitation (p < 0.0001).

Clinical Results to date

HEMERA‐1 is a multicenter, prospective, randomized, controlled phase 1 clinical trial. Anterior circulation large vessel occlusion (LVO) patients were assigned in a 3:1 ratio to receive either PP‐007 (320 mg/kg: 30 min bolus followed by 2‐hr infusion) plus (mechanical thrombectomy) MT vs. MT alone within 24 hours after symptom onset.

N=12/17 patients were randomized to PP‐007+MT, 1 was randomized but not treated, 4 patients were randomized to MT alone.

There was a statistically significant improvement in National Institutes of Health Stroke Scale (NIHSS) scores at 24 hours in patients randomized to PP‐007+MT vs. MT only patients (8.63 vs. 16.25, respectively).

Recanalization of the occluded vessel was achieved in all patients.

A transient systolic blood pressure increase (20–40 mm Hg) during the bolus was observed in all PP‐007 patients without any clinical consequences.

No significant safety concerns were identified for the adjunctive use of PP‐007 in patients with acute stroke with LVO undergoing MT.

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