VACNO® is a vascular albumin labeled with multiple caged nitric oxide (cNO) molecules to enhance its therapeutic index for the treatment of both hemorrhagic and ischemic stroke. VACNO®, if approved as a universal stroke drug, would have the potential to treat all stroke victims including the 97% - 98% of ischemic stroke patients currently untreatable by lytic therapy in the United States. VACNO® enhances blood flow in the ischemic area while protecting the vasculature and reducing hemorrhagic transformation so it could also expand the number of stroke patients treatable with lytic therapy as was recommended by the 2011 STAIR report (http://www.ncbi.nlm.nih.gov/pubmed/21852620). Thus, VACNO® will provide a paradigm change as a safe and effective universal stroke drug to treat all patients suffering from stroke worldwide.
Through peer review, NINDS/NIH has funded VACNO® to IND submission and NCATS/NIH has the mechanism to fund VACNO® through Phase I and multiple exploratory Phase II stroke trials. SynZyme would be open to a partnership with a global pharmaceutical company to expedite delivery of VACNO® to patients in the United States and worldwide.
SynZyme is developing and has received US patent protection for SanFlow (aka polynitroxylated pegylated hemoglobin (PNPH), nanoRBC, HemoZyme®) as a hemoglobin based cNO nano medicine. SanFlow has been shown to be efficacious in treating unmet medical indications not normally treated with blood transfusion such as traumatic brain injury complicated by hemorrhagic shock, stroke, and sickle cell disease. SanFlow also promises to fulfill the unmet needs in oxygen therapeutics put forth by the NIH/FDA/DOD Interagency Advisory Group in 2011(http://www.nhlbi.nih.gov/meetings/workshops/therapeutics.htm). Through peer review, NINDS/NIH is funding PNPH through IND and NCATS/NIH has the mechanism to fund PNPH through Phase I and multiple exploratory Phase II clinical trials. SynZyme would be open to a global pharmaceutical partnership to expedite delivery of SanFlow to patients in the United States and worldwide.
SynZyme is developing VitalHeme® (aka polynitroxylated dextran hemoglobin, PNDxHb) as an artificial blood for blood transfusion in response to two unmet medical needs. The first need is to deal with the observed increase in mortality and morbidity from transfusion of red blood cells stored longer than 2 weeks. The second need is to meet the challenge posted by the 2011 NIH/FDA/DOD Interagency Advisory Group to develop a high therapeutic index artificial blood. VitalHeme® has been shown to outperform fresh blood in a rat model of lethal hemorrhagic shock. VitalHeme® has also met the need to tame the toxicity of cell free hemoglobin and a first-in-man clinical trial protocol has been developed. SynZyme would be open to a partnership with a global pharmaceutical company to expedite approval of VitalHeme® as an artificial blood for transfusion medicine in the United States and worldwide.
SynZyme is developing VAXOL, which is VACNO® formulated with a cancer drug to better deliver cancer therapeutics to core of solid tumors and increase drug efficacy and survival of cancer patients. VACNO® has been shown to open the hypoxic core of a solid tumor to blood flow thus making the tumor more accessible by cancer therapeutic agents. VAXOL for cancer therapy can be fast tracked because VACNO® has completed pre-clinical safety and toxicology studies for IND and is currently being developed as a universal stroke therapeutic agent in the United States.
SynZyme will seek NIC/NIH and NCATS/NIH funding to initiate multiple exploratory cancer clinical trials once VACNO® receives FDA approval. SynZyme would be open to establishing a partnership with a multinational pharmaceutical company for the development of VAXOL.