Zion Medical, an Israeli biotech company that develops treatments for HIV and cancer, announced the results of the first clinical trial of HIV-drug Gammora, eliminating up to 99% of the HIV virus within four weeks of treatment.
Investigative Medicinal Product Gammora is a synthetic peptide compound derived from the integrase enzyme of HIV, which is responsible for introducing the genetic material of the virus into the DNA of the infected cell.
Gammora stimulates the integration of several DNA DNA fragments into the genomic DNA of the host cell, to the point that causes the self-destruction of the infected cell, called apoptosis.
The peptide, produced by PolyPeptide Labs in San Diego, California, has the potential to cure HIV-infected patients, destroying all the cells that carry the HIV-virus genome.
This is opposed to commercially available retroviral treatments, the so-called "cocktail", which simply suppresses the spread of the virus, but does not cure the infection.
Between July and August of 2018, Zion Medical conducted a human Phase 1 / 2a clinical trial of Gammora, reaffirming results of previous preclinical tests that demonstrated the safety and efficacy of the drug by killing HIV-infected cells.
In part I of this process, nine patients infected with HIV at the Ronald Memorial Hospital of Dr. Ronald Bata in Entebbe, Uganda, were randomized to receive 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 or five weeks.
Most patients showed a significant reduction in the viral load of up to 90% of the baseline during the first four weeks.
In part II of the study, carried out two weeks after the first, patients received Gammora with additional combined retroviral treatment during another four weeks to five weeks.
Patients received both commercial 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.
The results found that combined treatment patients demonstrated sustained viral suppression and achieved HIV-1 RNA <300 copies / ml and showed up to 99% reduction in viral load from baseline within four weeks.
Over the past 10 weeks, patients in both studies have shown that Gammora is a safe and well-tolerant drug that has no side effects.
Patients showed a significant increase in the CD4 cell count, up to 97% of the base.
CD4 cells, also referred to T cells or auxiliary T cells, play an important role in the immune system of the body and are an indicator of their overall health.
"These first clinical results have exceeded our expectations and hopes of finding a cure for a disease that was discovered more than 35 years ago," says Dr. Esmira Naftali, head of development of Zion Medical. "Given the limited 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 long period of time."
Abraham Loyter, a professor at the Hebrew University of Jerusalem, has begun investigating this drug novelty about 10 years ago, with patents being granted for the peptide in 2015 and 2017 (United States Patent No. 9163067, 9738878).
Zion Medical licensed the compound and continued the research and development through preclinical and clinical stages, building a complete team of researchers throughout the development of Gammora.
On August 31, 2018, Zion Medical submitted another patent application with the US Patent and Trademark Office. UU. To obtain an updated version of the peptide and the final composition of the drug.
The Mount Sinai hospital in the city of New York has collaborated with Zion in stages of development and can be associated with the company again in the future.
The company expects to start Phase 2b in the coming months, which involves about 50 patients receiving Gammora for two or three months.
Zion Medical, based in Israel, was created in 2014 with the mission of developing innovative medical solutions for HIV / AIDS and cancer.
It is known for its patented synthetic peptide Gammora, which is derived from integrating HIV enzyme, and has proven to be effective in killing HIV-infected cells and also showing promising results with some types of cancer cells.
. PR Newswire.