Since my cancer diagnosis in 1996, I've spent a good portion of my time investigating just about every new cancer treatment you can imagine. And I believe the novel therapy developed by Genelux Corporation, which was was founded in 2001 and has offices in California and Europe, could save countless lives and fundamentally change the way we look at cancer treatment.
Genelux, which has received little national media attention, has developed a virus-based treatment called GL-ONC1 that kills cancer cells throughout the body effectively without harming healthy cells or tissues. In animal studies for this attenuated vaccinia virus, which is from the Lister strain, more than 40 human cancers were completely eradicated. About 90 percent of the more than 10,000 mice that received the therapeutic dose were completely cured of a variety of cancers.
While a number of alleged wonder drugs kill cancer in mice, most have not worked in people. But human trials for GL-ONC1 are underway and already showing very positive results at such prestigious cancer institutions as Memorial Sloan-Kettering in New York and the UC San Diego Moores Cancer Center, as well as in Europe. More than 60 people, mostly patients who've exhausted every other treatment option, have enrolled in these trials for a variety of cancers.
GL-ONC1 has shown remarkable effectiveness as a single agent therapy (monotherapy) and also works synergistically in combination with chemotherapy, radiation therapy and monoclonal antibodies. At the Moores Cancer Center trial in San Diego, Genelux is being combined with chemo and radiation to treat head and neck cancers.
James Eldridge, 56, a nutritionist and photographer from Ukiah, Calif., enrolled in the Moores trial in April after being diagnosed with stage IV cancer, with 26 of 52 lymph nodes turning up positive for cancer. Three weeks ago, at his first post-treatment visit, Eldridge tells The Reno Dispatch that he was scoped by his radiologist and told that there was no clinical evidence of cancer.
"I am quite sure that Genelux has saved my life," says Eldridge. "The radiation only took care of the cancer that was in the head and neck area, whereas the virus cleared my body of any free-floating cancer cells. I believe I am cured. I hope to go back to work in a month. I'm so thankful I was a part of this trial. There are so many people suffering, I just hope this treatment gets approved as soon as possible."
In every human trial Genelux has hosted, there are stories like this in which patients have seen their cancer wiped out. It's still early in the development process of this treatment, of course, and cancer experts are characteristically reluctant to get too excited or share details of these early pre-published results. But clinicians are clearly impressed.
Dr. Loren Mell, director of the Head and Neck Radiation and Oncology Service at Moores, runs the Genelux trial in which Eldridge enrolled. Mell tells The Reno Dispatch that while it is too early to comment specifically on the human trial results, "There are a lot of reasons to be excited about this therapy. The pre-clinical data is certainly what we like to see. It has shown to be very effective against tumors. And I would say that it has been very encouraging in human trials. We are definitely excited and encouraged by the responses so far."
So how does GL-ONC1 work? The virus, which was used in the first smallpox vaccine two centuries ago, is delivered intravenously, then navigates through the body’s immune response to reach its target. It smartly locates and kills all cancer cells throughout the body (solid tumors, liquid tumors, cancer stem cells and metastasis). The virus has also been genetically engineered to emit light, so the progress of the therapy can be tracked. And again, it does not harm healthy cells.
When the virus enters the cancer cell, it begins to replicate rapidly and infects the cell, lighting up like a Christmas tree in the process, and letting the clinician know that cancer cells are being destroyed wholesale. When the body is cleared of all cancer cells, the lights go out and the cell debris as well as the virus are cleared from the body.
There are virtually no side effects other than very mild fever and chills for several hours, at most. And the therapy works rapidly, sometimes as fast as a few weeks, and I've not found a situation in my extensive research of this company in which, when a therapeutic dose is given, it doesn't work - even on stage IV cancers.
While Genelux is currently conducting Phase I/II human trials for this virus at Moores, Sloan Kettering, Royal Marsden Hospital in London and the Tubingen University Hospital in Germany, it's likely you've not heard of this treatment, or this company. I hadn't until very recently – and it's my job to know about these kinds of companies.
Genelux puts out occasional press releases and there are references in various medical journals. And of course you can find all its clinical trials on clinicaltrials.gov. But there hasn't been much press coverage. Genelux has kept a low profile and has been conservative in its public relations.
But in exclusive interviews, Aladar Szalay, PhD, the company's founder, chairman and CEO, and Tony Yu, PhD, who heads the clinical trials, explained the treatment to me in great detail and shared with me just where they hope to go from here.
Szalay, a kind, soft-spoken, patient-focused leader with impeccable international science credentials, doesn't want anything but the facts to come out about this treatment. It just isn't his nature to boast about the undeniably astounding early results he has seen with his technology. He only agreed to talk to me, I suspect, because I am a cancer patient myself, and an advocate for other cancer patients.
"It has taken years to get our clinical trials going," he tells me. "GL-ONC1 has proven to be safe and well tolerated, with early signs of anti-tumor activity. We are very encouraged by what we have seen to this point."
That's about all the hype you'll get out of him. It's refreshing, actually. Szalay is a visionary, and while he keeps things close to the vest, he knows Genelux is really on to something here.
Genelux's Yu, who is quite adept at putting all the science jargon into words that everyone can understand, notes that while it's difficult to have a general summary on the human trials at this point, "We have seen complete response or no evidence of disease in all evaluable patients in the UCSD combination therapy trial."
Yu notes that Genelux has also seen conversion of progressive diseases to stable diseases in many patients in the Royal Marsden trial when the virus is used as monotherapy. "However," he adds, "please keep in mind, in that trial we did dose escalation, starting from very low dose levels and escalating to higher doses. The higher dose would be more meaningful in evaluating efficacy. In the Tubingen trial, we have demonstrated complete removal of tumor cells from peritoneal fluid after viral therapy."
In other words, it works on just about everyone who has tried it. Of course, using a virus to treat cancer is not a new study. It's been around for several decades. Besides vaccinea, other oncolytic viruses used in clinical trials are adenovirus, reovirus, measles, herpes simplex and Newcastle disease viruses. But Genelux has taken this science to new territory with this treatment. I believe vaccinia is the most promising and safest of the oncolytic viruses currently being tested.
As I said, I'm not a fan of hype and hyperbole, especially when it comes to cancer treatments. But the inspirational story of Genelux, which has survived and thrived in a very competitive world dominated by big pharma, serves as a beacon of hope for those of us who suffer from cancer and oftentimes the toxic treatment that follows.
I believe the work Genelux is doing could result in an entirely new paradigm in the field of oncology and delivery of medicine in general. The company embraces the convergence of virology, whereby live organisms are treating live cells, as opposed to dead substances in the form of drugs, which as my fellow cancer patients know are often harder on the patient than the disease.
Genelux hopes to soon begin several more trials for a variety of cancers. Stay tuned. I'll be following this company's journey closely here at The Reno Dispatch. Meantime, if you're a cancer patient or just want more information on the company, contact Timothy Wilson at Nexit Venture Partners, Inc., a consultant to Genelux. You can reach Wilson at docteur@san.rr.com, or at his office 858-259-8922.
GL-ONC1 has shown remarkable effectiveness as a single agent therapy (monotherapy) and also works synergistically in combination with chemotherapy, radiation therapy and monoclonal antibodies. At the Moores Cancer Center trial in San Diego, Genelux is being combined with chemo and radiation to treat head and neck cancers.
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| Cancer survivor James Eldridge |
"I am quite sure that Genelux has saved my life," says Eldridge. "The radiation only took care of the cancer that was in the head and neck area, whereas the virus cleared my body of any free-floating cancer cells. I believe I am cured. I hope to go back to work in a month. I'm so thankful I was a part of this trial. There are so many people suffering, I just hope this treatment gets approved as soon as possible."
In every human trial Genelux has hosted, there are stories like this in which patients have seen their cancer wiped out. It's still early in the development process of this treatment, of course, and cancer experts are characteristically reluctant to get too excited or share details of these early pre-published results. But clinicians are clearly impressed.
Dr. Loren Mell, director of the Head and Neck Radiation and Oncology Service at Moores, runs the Genelux trial in which Eldridge enrolled. Mell tells The Reno Dispatch that while it is too early to comment specifically on the human trial results, "There are a lot of reasons to be excited about this therapy. The pre-clinical data is certainly what we like to see. It has shown to be very effective against tumors. And I would say that it has been very encouraging in human trials. We are definitely excited and encouraged by the responses so far."
So how does GL-ONC1 work? The virus, which was used in the first smallpox vaccine two centuries ago, is delivered intravenously, then navigates through the body’s immune response to reach its target. It smartly locates and kills all cancer cells throughout the body (solid tumors, liquid tumors, cancer stem cells and metastasis). The virus has also been genetically engineered to emit light, so the progress of the therapy can be tracked. And again, it does not harm healthy cells.
When the virus enters the cancer cell, it begins to replicate rapidly and infects the cell, lighting up like a Christmas tree in the process, and letting the clinician know that cancer cells are being destroyed wholesale. When the body is cleared of all cancer cells, the lights go out and the cell debris as well as the virus are cleared from the body.
There are virtually no side effects other than very mild fever and chills for several hours, at most. And the therapy works rapidly, sometimes as fast as a few weeks, and I've not found a situation in my extensive research of this company in which, when a therapeutic dose is given, it doesn't work - even on stage IV cancers.
While Genelux is currently conducting Phase I/II human trials for this virus at Moores, Sloan Kettering, Royal Marsden Hospital in London and the Tubingen University Hospital in Germany, it's likely you've not heard of this treatment, or this company. I hadn't until very recently – and it's my job to know about these kinds of companies.
Genelux puts out occasional press releases and there are references in various medical journals. And of course you can find all its clinical trials on clinicaltrials.gov. But there hasn't been much press coverage. Genelux has kept a low profile and has been conservative in its public relations.
But in exclusive interviews, Aladar Szalay, PhD, the company's founder, chairman and CEO, and Tony Yu, PhD, who heads the clinical trials, explained the treatment to me in great detail and shared with me just where they hope to go from here.
Szalay, a kind, soft-spoken, patient-focused leader with impeccable international science credentials, doesn't want anything but the facts to come out about this treatment. It just isn't his nature to boast about the undeniably astounding early results he has seen with his technology. He only agreed to talk to me, I suspect, because I am a cancer patient myself, and an advocate for other cancer patients.
"It has taken years to get our clinical trials going," he tells me. "GL-ONC1 has proven to be safe and well tolerated, with early signs of anti-tumor activity. We are very encouraged by what we have seen to this point."
That's about all the hype you'll get out of him. It's refreshing, actually. Szalay is a visionary, and while he keeps things close to the vest, he knows Genelux is really on to something here.
Genelux's Yu, who is quite adept at putting all the science jargon into words that everyone can understand, notes that while it's difficult to have a general summary on the human trials at this point, "We have seen complete response or no evidence of disease in all evaluable patients in the UCSD combination therapy trial."
Yu notes that Genelux has also seen conversion of progressive diseases to stable diseases in many patients in the Royal Marsden trial when the virus is used as monotherapy. "However," he adds, "please keep in mind, in that trial we did dose escalation, starting from very low dose levels and escalating to higher doses. The higher dose would be more meaningful in evaluating efficacy. In the Tubingen trial, we have demonstrated complete removal of tumor cells from peritoneal fluid after viral therapy."
In other words, it works on just about everyone who has tried it. Of course, using a virus to treat cancer is not a new study. It's been around for several decades. Besides vaccinea, other oncolytic viruses used in clinical trials are adenovirus, reovirus, measles, herpes simplex and Newcastle disease viruses. But Genelux has taken this science to new territory with this treatment. I believe vaccinia is the most promising and safest of the oncolytic viruses currently being tested.
As I said, I'm not a fan of hype and hyperbole, especially when it comes to cancer treatments. But the inspirational story of Genelux, which has survived and thrived in a very competitive world dominated by big pharma, serves as a beacon of hope for those of us who suffer from cancer and oftentimes the toxic treatment that follows.
I believe the work Genelux is doing could result in an entirely new paradigm in the field of oncology and delivery of medicine in general. The company embraces the convergence of virology, whereby live organisms are treating live cells, as opposed to dead substances in the form of drugs, which as my fellow cancer patients know are often harder on the patient than the disease.
Genelux hopes to soon begin several more trials for a variety of cancers. Stay tuned. I'll be following this company's journey closely here at The Reno Dispatch. Meantime, if you're a cancer patient or just want more information on the company, contact Timothy Wilson at Nexit Venture Partners, Inc., a consultant to Genelux. You can reach Wilson at docteur@san.rr.com, or at his office 858-259-8922.
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