Zion Medical is an Israeli biotechnology company focused on the development of innovative treatments for AIDS and cancer. Recently, the company published the first clinical results of the experimental HIV drug Gamora. The drug cleared up to 99 percent of patients of HIV within four weeks of treatment, the data showed.
Gamora is a synthetic peptide compound derived from HIV integration enzymes, which insert genetic material from the virus into the DNA of infected cells. The drug stimulates multiple pieces of HIV DNA to be integrated into the genomic DNA of the host cell until it reaches the point that triggers the self-destruction of the infected cell, known as apoptosis. Gammora, produced by PolyPeptide Labs in San Diego, California, has the potential to cure people living with HIV by destroying all cells that carry the HIV genome. Antiretroviral drugs on the market, known as "cocktail" therapy, can only inhibit the replication and spread of the virus, but do not cure infection.
July-August 2018, Zion Medical conducted a Phase I/IIa clinical study in Gamora, which confirmed previous clinical results that the drug is safe and effective in killing HIV-infected cells. In the first part of the study, nine HIV-infected patients at the Ronald Bata Memorial Hospital in Uganda were randomly assigned a Gamora treatment group of 0.05-0.2mg/kg, 0.1-0.3mg/kg or 0.2-0.4mg/kg for a course of 4-5 weeks. During the first 4 weeks, the viral load of most patients decreased significantly by 90% relative to the baseline.
two weeks after the completion of the first part, the patient underrated Gamora and other antiretroviral drugs for 4-5 weeks and received a daily lopinavirvir /ritonavir, LPV-r, 800mg/200mg) combined with Gamora (0.2-0.4mg/kg) twice a week, or only LPV-r treatment. The results showed that the combined treatment group showed continuous virological inhibition and reached HIV-1 RNA<300 copy/mL, with HIV load dropping by 99% from the baseline within 4 weeks.
the entire 10-week treatment period, patient safety data from both studies demonstrated that Gamora was a safe and well-to-bear drug with no side effects. In addition, the patient's CD4 cell count increased significantly from the baseline by up to 97%. CD4 cells, also known as T cells or T-assisted cells, play an important role in the body's immune system and are a key indicator of overall health.
Zion Medical hopes to start phase IIb clinical trials in the coming months, with about 50 HIV-infected people receiving Gamora treatment for 2-3 months.
Esmira Naftali, head of research and development at the company, said, "These preliminary clinical results exceed our expectations and there is hope of finding a cure that we have been looking for for the past 35 years." We hope to include more patients in the next Phase IIb study to demonstrate Gamora's effectiveness. Professor
Graham Loyter of the Hebrew University of Jerusalem began studying the new drug about 10 years ago and obtained U.S. patents for the peptide in 2015 and 2017 (patent numbers: 9163067, 9738878). Zion Medical has licensed the drug and has been developing it in preclinical and clinical studies, and has established an entire research team around Gamora development. On August 31, 2018, Zion Medical filed another patent with the U.S. Patent and Trademark Office for an updated version of the peptide compound and the final pharmaceutical composition. (Bio Valley)