SOUTH PLAINFIELD, NJ. November 1, 2016.
Unique activity Noted in Drug
Prolong Pharmaceuticals, LLC, a biopharmaceutical company dedicated to developing products to treat several diseases and their debilitating comorbidities announced today that it has presented data on the toxicology, pharmacokinetic and pharmacodynamic profile of its novel anti-neutropenia drug, ANF-RHO. The data was presented at the 7th Euro-Global Summit on Toxicology and Applied Pharmacology in Rome, Italy in by Dr. Hemant Misra, VP of Clinical Development at Prolong. These keynote addresses received a honorary certificate of recognition by the Euro Toxicology 2016 Organizing Committee.
In addition to unremarkable safety data suggesting that prolonged dosing is possible, ANF-RHO was found to have superior pharmacokinetic and a prolonged and superior impact upon neutrophil maturation in animals and healthy volunteers as compared to Neulasta®.
Chemotherapy such as used to treat breast cancer or other solid tumors often results in neutropenia – abnormally low neutrophil levels. Neutrophils are the key defense against bacterial infection. Neupogen® and Neulasta are currently among the approved products to treat neutropenia. However, these products must be administered the day after chemotherapy and cause significant side effects such as bone pain, likely due to the high dose needed to induce neutrophil maturation and release.
“These results confirm superiority of ANF-RHO in animal models,” stated Dr. Misra. “We believe this work demonstrates the potential therapeutic benefit to oncology patients by providing more convenient dosing and preventing the onset of neutropenia. The unique features of ANF-RHO suggest that a significantly lower dosage may achieve improved and sustained neutrophil levels sufficient to mitigate severe neutropenia and therefore provide an important alternative for treating conditions of neutropenia with fewer dose-related side effects, known to be associated with the standard treatments.”
Details of Presentation
Two Keynote talks were given at the summit meeting: Preliminary Results From A Long-term Repeat Dose Toxicity and ToxicoKinetic Study of ANF-RHO, a Novel Anti-Neutropenic Factor and Toxicology Studies and Results for Determining Safety of a Novel Anti-Neutropenic Factor – ANF-RHO™
The following findings were reported:
- ANF-RHO had no toxicity issues that precluded clinical development.
- The circulating life of ANF-RHO was superior to Neulasta (The t1/2 of ANF ranged between 38.5 and 51 hrs as compared to pegfilgrastim (28hr).
- Pharmacodynamic results showed that ANF RHO had prolonged impact on absolute neutrophil counts and CD34+ (progenitor neutrophil cell marker) levels as compared to Neulasta.
Anti-Neutropenia Factor type RHO (ANF-Rho™) is a new granulocyte-colony stimulating factor (G-CSF) consisting of a novel pegylated version of native human recombinant G-CSF protein. ANF-RHO has distinct biophysical and biological properties that produce a distinct pharmacokinetic and pharmacodynamic profile as compared to either pegfilgrastim (Neulasta®).
Phase I studies in healthy volunteers has been completed. Phase 2 clinical trial planning is underway with a focus on reducing or preventing the occurrence and severity of neutropenia resulting with the use of myelo-suppressive chemotherapy.
About Prolong Pharmaceuticals
Headquartered in South Plainfield, New Jersey, Prolong Pharmaceuticals, LLC is developing products to treat several diseases and their debilitating comorbidities associated with reduced quality of life, increased medical cost and significant mortality. Prolong’s senior management team includes inventors of the most successful drug delivery technology in pharmaceutical history, PEGylation, now responsible for the development of a dozen drugs improving the quality of life for sufferers of hepatitis, kidney disease, and a number of life-threatening diseases.