Israeli biotech company, Zion Medical has announced the results of the first clinical trial of HIV-drug Gammora, which it claims eliminated up to 99 percent of the HIV virus within four weeks.
In a press release, Medical said between July and August 2018, it conducted a Phase 1/2a human clinical trial of Gammora, which showed that the drug was safe and effective in killing HIV-infected cells.
Safe and well tolerated with no side effects
The company said Part I of the trial was done at Dr. Ronald Bata Memorial Hospital in Entebbe, Uganda with nine participants. Zion Medical said the participants “were randomly assigned to receive either 0.05-0.2 mg/kg, 0.1- 0.3 mg/kg, or 0.2-0.4 mg/kg of Gammora for up to four to five weeks. Most patients showed a significant reduction of the viral load of up to 90% from the baseline during the first four weeks.”
Zion Medical, which specializes in cancer and HIV treatments, said in the second part of the trial, which was conducted a fortnight after the initial study, patients received Gammora with additional retroviral treatment for another four to five weeks.
The company said the patients were given “either 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 percent reduction in viral load from baseline within four weeks.”
Both studies, Zion Medical said, showed that Gammora was safe, well-tolerable, with no side effects. It said the patients showed a significant increase of the CD4 cell count.
Zion Medical head of development, Esmira Naftali said the results of the clinical trial were beyond the company’s expectations, as they promised hope that a cure for HIV could be found. “Given the limited nature of this study, we are excited to prove the efficiency of our drug in Phase 2b with a greater number of participants over a longer period of time.”
Zion Medical, which was established in 2014, said it expected to carry out Phase 2 of the clinical trial in the next few months. The next trial will have 50 participants and will be carried out over two to three months.
Research on the drug began 10 years ago at the Hebrew University of Jerusalem and was led by Abraham Loyter.
How Gammora works
Gammora has been described as an innovative treatment consisting of a synthetic peptide compound derived from the HIV-derived integrase. Integrases are enzymes produced by retroviruses, such as HIV, that enable their genetic material to be integrated into the DNA of the infected cell.
Taking advantage of this process, Gammora stimulates the integration of multiple HIV DNA fragments into the host cell’s genomic DNA. This then essentially triggers the infected cell’s apoptosis or self-destruction.
Zion Medical said Gammora was different from retroviral medication, as the latter only suppress the spreading of HIV, but does not cure the infection.
On its website, the company also lists several disadvantages of commercially available retroviral medications, saying up to 15 percent of HIV positive people are likely to be infected with a virus that is resistant to medicines; that the medication could have short- and long-term physical and psychological side-effects, and that there was a danger that incorrect usage of medicine can lead to the development of a mutation of the virus that is drug resistant.
Since Zion Medical announced the results of its clinical trials, there has been increased excitement that an HIV cure, which has eluded scientists for about 35 years could be on the horizon.
To address this excitement, Zion Medical took to Twitter to advise that it was not there yet and a cure for HIV could still be far.
“We want to thank everyone for their interest in the promising results of our first clinical trial. Like you, we are hopeful that Gammora may one day offer those affected by HIV a viable path to ridding themselves of infection. Much work remains in this mission, including additional trials, publication of results and steps required to make Gammora commercially available. We are not there yet, but we are a step closer, hopeful – and committed to keeping you informed of our progress,” the company said.
It added that it hoped that the official results of its clinical trials will be published in a peer-reviewed scientific journal in early 2019.
New drug could be quackery, skeptics warn
But not everyone is convinced, with some skeptics saying this could be quackery. Francois Venter from the Institute of Reproductive Health and HIV at University of Witwatersrand in South Africa was quite critical, charging: “The HIV world has seen quackery in different forms for decades – sadly this smacks of more of it.”
He was also unimpressed by claims that Gammora does not have side-effects, describing this as “over-the-top biological claims that appear in public before the formal literature [is published] and should be viewed with deep scepticism.”
The Aids Map website took issue with the fact that the study’s results had not been presented at a conference nor published in a peer-reviewed journal.
“The drug appears to be a broad-spectrum disrupter of viral replication (like ribavirin, a drug previously used in hepatitis C treatment). It might work to limit viral proliferation in established infection and the infection of further cells (as other antiretroviral drugs do). However, there is no reason it would be active against the reservoir of latently infected cells (which already contain integrated HIV DNA). If it could cure, it would need to be active against the latent reservoir,” the website said.
It is estimated that there are about 36.9 million HIV positive people in the world. In 2017, an estimated 940,000 people died of HIV-related illnesses worldwide.