Overview: What is Preimplantation Factor (PIF) and Synthetic PreImplantation Factor (sPIF)?
PIF is a 15 amino acid molecule with remarkable diagnostic and therapeutic properties. It is produced and secreted within minutes of conception by a 4-cell stage viable embryo and then continuously throughout pregnancy. It serves as a detectable biomarker of a viable pregnancy. PIF is the enabler of human pregnancy. Without PIF, no fertilized egg is viable.
sPIF is the synthetic analog of PIF: A molecule in liquid suspension that can be injected subcutaneously to stimulate immune-regulating and regenerative properties for human health.
Roles of PIF in Pregnancy
- Regulates maternal immune system
- Provides immune tolerance without suppression
- Creates immune homeostasis with fetus (Harmony)
- Prevents transplant rejection phenomenon
- Improves symptoms of several maternal autoimmune diseases
- Promotes placental formation
- Protects fetus from adverse events (Maternal immune attacks)
- Promotes fetal growth: Augments the differentiation and/or proliferation of various categories of stem cells in multiple body systems
Advancing sPIF Beyond Pregnancy:
From Embryo to Healing
Prince Biotech is positioned to advance the molecule to benefit humanity. Among PIF and sPIF’s many attributes:
- Proven role in pregnancy
- Proven therapeutic benefits in animals with 50+ scientific publications
- Proven safety profile – absence of toxic side effects in NIH 9-month toxicology study and in human autoimmune hepatitis study
- Significant potential for human health across a broad array of autoimmune diseases and inflammatory conditions (e.g., acute radiation syndrome) and complex disorders requiring neural regeneration and repair properties (e.g., traumatic brain injuries and stroke)
The Power of sPIF: Immune Harmony & Regeneration
Prince Biotech’s synthetic Preimplantation Factor (sPIF) offers two transformative benefits for human health:
- Immune System Modulation
sPIF helps restore balance to the immune system by regulating harmful inflammation and immune dysfunction—key contributors to many acute and chronic health problems. It promotes immune harmony without suppressing the body’s natural defenses. - Cell Regeneration
sPIF stimulates the regeneration of healthy cells from stem cells in vital organs and tissues—including the brain, gut, muscles, and bone marrow—where cell death from injury, toxins, or disease would otherwise cause lasting disability or mortality.
These dual capabilities position sPIF as a promising therapeutic for a wide range of inflammatory and degenerative conditions.
Therapeutic Applications of sPIF
Acute Radiation Syndrome (ARS)
Acute Radiation Syndrome, or radiation sickness, is a life-threatening condition triggered by exposure to high doses of ionizing radiation over a short period. This can occur due to nuclear accidents, acts of terrorism, or military conflict involving nuclear weapons. The most severe form, Gastrointestinal Syndrome (ARS-GI), devastates the GI tract, leading to vomiting, diarrhea, dehydration, inflammation, fever, and infections. Without effective treatment, it often results in death or lifelong disability.
Currently, there are no FDA-approved drugs to treat ARS-GI, making it a critical unmet need and a top priority for national and global security.
In 2024, studies conducted by the NIH/NIAID/RNCP at the Armed Forces Radiobiology Research Institute (AFRRI) demonstrated that sPIF significantly improved survival in (bone marrow shielded) male mice exposed to high dose radiation. Treated mice showed an 88% survival rate compared to 50% in untreated controls (a 76% increase in survival).
A 2017 study in unshielded mice exposed to high dose radiation, demonstrated a 100% survival rate in treated mice vs. 0% survival in untreated mice.
sPIF not only improved survival but also restored GI structure and function, regenerated intestinal cells, and reestablished immune balance—offering a promising breakthrough in radiation countermeasures.
Traumatic Brain Injury (TBI)
Traumatic Brain Injury results from external forces such as blunt trauma, falls, vehicle accidents, sports injuries, or military blasts. It can also occur from violent shaking, as seen in Shaken Baby Syndrome, or repeated impacts, as in Chronic Traumatic Encephalopathy (CTE) among athletes.
TBI unfolds in two phases: acute and chronic. The acute phase involves swelling, bleeding, oxygen deprivation, and inflammation, which can lead to brain death if not stabilized quickly. The chronic phase brings long-term consequences like seizures, cognitive decline, emotional instability, and loss of independence.
Despite its prevalence, there is no direct treatment for the immune dysregulation or neuronal death caused by TBI. However, sPIF has shown remarkable promise in animal models. It rapidly reversed both acute and chronic brain damage, improved survival, reduced motor and cognitive deficits, and protected neurons from further loss. These findings suggest sPIF could revolutionize how we treat brain injuries, offering hope for recovery and improved quality of life.
Stroke
Stroke is a medical emergency that occurs when blood flow to the brain is interrupted, depriving brain cells of oxygen and nutrients. There are two main types: ischemic (caused by clots) and hemorrhagic (caused by bleeding). Stroke is one of the leading causes of death globally, and survivors often face lifelong disabilities such as paralysis, speech difficulties, and cognitive impairments.
Current treatments for ischemic stroke focus on restoring blood flow using clot-busting drugs like tPA, but these must be administered within a narrow time window. Rehabilitation therapies help patients regain function, but there is no treatment that addresses the immune response or regenerates lost neurons.
sPIF offers a new frontier in stroke therapy. In preclinical studies, it reversed both acute and chronic brain damage, improved survival, reduced motor and cognitive impairments, and protected neurons from death. Its dual action—modulating inflammation and promoting regeneration—positions sPIF as a potential game-changer in stroke recovery.
IVF Diagnostic Test
There is currently no method to accurately predict the viability of a fertilized embryo in the IVF process. This leads to a low pregnancy success rate and to financial and emotional burdens on prospective parents. This is a huge unmet need globally.
Prince Biotech is developing a diagnostic test for Invitro Fertilization to detect PIF in embryo culture media (ECM) to more accurately predict embryo viability and has the potential to benefit the IVF industry and prospective parents.
