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A cure instead of a cocktail Investigational Medicinal Product (IMP) Gammora is a synthetic peptide compound derived from the HIV enzyme integrase.

This enzyme is responsible for inserting the virus’ generic material into the DNA of the infected cell. Gammora works by stimulating the integration of multiple HIV DNA fragments into the host cell’s genomic DNA, triggering the self-destruction of the infected cell (apoptosis).

Gammora stimulates the integration of multiple HIV DNA fragments into the host cell's genomic DNA, triggering the self-destruction of the infected cell The peptide, produced by California-based PolyPeptide Labs, has the potential to cure HIV infected patients by destroying all cells carrying the HIV virus-genome.

Unlike the commercially available retroviral treatments, the “cocktail”, which aims to suppress the spread of the virus, Gammora is designed to kill HIV-infected cells, without harming uninfected cells. Abraham Loyter, professor at the Hebrew University of Jerusalem, first started research on this novelty drug a decade ago, having been granted patents for the peptide in 2015 and 2017.

Zion Medical in-licensed the compound and has continued research and development through pre-clinical and clinical stages. On August 31, 2018, Zion Medical filed another patent application with the U.S. Patent and Trademark Office for an updated version of the peptide and final drug composition.

RELATED: Read about the impact digital disruption is having on clinical trials Successful Phase 1/2a human clinical trial results Between July and August 2018, Zion Medical conducted a Phase 1/2a human clinical trial of Gammora, reaffirming prior preclinical test results which had showed the safety and effectiveness of the drug in killing HIV-infected cells. In Part I of this trial, nine HIV-infected patients at the Dr. Ronald Bata Memorial Hospital in Entebbe, Uganda, were randomly assigned 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 4-5 weeks. Most patients showed a significant reduction of the viral load of up to 90% from the baseline during the first four weeks.

Most patients showed a significant reduction of the viral load of up to 90% from the baseline in the first four weeks In Part II of the study, conducted two weeks after the first, patients were given Gammora with additional retroviral treatment combined for another 4-5 weeks.

There is hope that patients using the treatment could experience a full reduction in around 6 months. If the Phase 2b trial is successful, Zion Medical is looking for the drug to be commercially available in the next one to two years. They will be targeting countries where approvals can be made on a quicker time frame (Africa, India, China). Zion Medical is aiming for commercial availability in the next one to two years if further trials are successful Speaking to Pharma IQ, Zion also noted that Gammora showed effectiveness with patients who were currently resistant to the traditional “cocktail” treatment. One of the patients in the Phase 1/2a trial was resistant to the standard antiretroviral drugs. After 2 weeks with Gammora, she was able to remove 65% of her viral load.

Interestingly, throughout the 10 weeks, Gammora was shown to be highly tolerable with patients exhibiting no side effects. With chronic HIV sufferers currently taking a number of tablets daily with varying side effects, a single injection treatment with no side effects could have a drastic impact on a patient’s quality of life.

Gammora has shown effectiveness with patients who were resistant to the tranditional cocktail treatment Over the course of the trial, patients also showed a significant increase of the CD4 cell count – up to 97% from the baseline. CD4 cells, referred to as T cells or T helper cells, play an important role in the body’s immune system and are an indicator of its overall health. These results indicate the positive impact of Gammora on the wider system of HIV-infected participants.

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Delivery is also possible via land transport which serves the sub-region via partner buses such as UTB and TCV in all countries of West Africa so that our patients can acquire their orders as quickly as possible. Our primary objective is to provide you with your order within a maximum of 3 days. This period is defined by the day the patient's product becomes available. As you know, each patient's product is different in order to best match their case. Its production, therefore, begins on the day of the order by our experts.