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Zion Medical, an Israeli biotech company developing HIV and cancer treatments, has announced the results of the first clinical trial of HIV-drug Gammora, eliminating up to 99 percent of the HIV virus within four weeks of treatment.
Investigational Medicinal Product Gammora is a synthetic peptide compound derived from the HIV integrase enzyme, which is responsible for inserting the virus's genetic material into the DNA of the infected cell.
Gammora stimulates the integration of multiple HIV DNA fragments into the host cell's genomic DNA, to an extent that triggers the self-destruction of the infected cell, called apoptosis.
The peptide, produced by San Diego, California-based PolyPeptide Labs, has the potential to cure HIV infected patients by destroying all the cells carrying the HIV-genome virus.
This is the commercially available retroviral treatments, so-called "badtail," which merely suppresses the spread of the virus, but does not cure the infection.
Between July and August 2018, Zion Medical conducted a Phase 1 / 2a human clinical trial of Gammora, reaffirming results of prior preclinical tests that had shown the safety and effectiveness of HIV-infected cells.
In Part I of this trial, nine HIV-infected patients at the Ronald Bata Memorial Hospital in Entebbe, Uganda, were randomly badigned to receive either 0.05-0.2 mg / kg, or 0.1-0.3 mg / kg, or 0.2-0.4. mg / kg of Gammora for up to four weeks to five weeks.
Most patients showed significant changes in the baseline during the first four weeks.
In Part II of the study, patients were given Gammor with additional retroviral treatment combined for another four weeks to five weeks.
Patients received commercially available lopinavir 800 mg and ritonavir 200 mg (LPV + r) daily in combination with Gammora 0.2-0.4 mg / kg given twice a week, or LPV + r only.
The results found that combined-treated patients demonstrated sustained viral suppression and achieved HIV-1 RNA <300 copies / mL, and showed up to 99 per cent reduction in viral load from baseline within four weeks.
Through the 10 weeks, Gammora is a safe and well-tolerable drug, exhibiting no side effects.
Patients showed a significant increase in CD4 cell count – up to 97 per cent from the baseline.
CD4 cells, also referred to as cells or helper cells, play an important role in the body's immune system and are indicative of its overall health.
"Dr. Esmira Naftali, head of development at Zion Medical, said," These first clinical results have been discovered over 35 years. "Given the nature of this study, we are excited to prove the efficacy of our drug in Phase 2b with a greater number of participants over a longer period of time."
Abraham Loyter, professor at the Hebrew University of Jerusalem, has been licensed for the peptide in 2015 and 2017 (U.S. Patent No. 9163067, 9738878).
Zion Medical in-licensed the compound and has been continuing research and development through pre-clinical and clinical internships, building an entire team of researchers around the development of Gammora.
On August 31, 2018, Zion Medical filed a patent application with the US Patent and Trademark Office for an updated version of the peptide and final drug composition.
New York City's Mount Sinai hospital has collaborated with Zion in earlier stages of development and might partner with the company again in the future.
The company hopes to start Phase 2b in the coming months, involving around 50 patients who are given Gammora over two to three months.
Israel-based Zion Medical was established in 2014 with the mission to develop groundbreaking medical solutions for HIV / AIDS and cancer.
It is known for its patented synthetic Gammora peptide, which is derived from the HIV integrase enzyme, and has been proven to be effective in killing HIV-infected cells, and which has also shown promising results with certain types of cancer cells.
. PR Newswire.
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