Wednesday, July 17, 2013

EXCLUSIVE: Does San Diego Biotech Firm Have a Cure for Cancer?

As a journalist, cancer survivor and patient advocate, I've been subjected to my share of hyperbole from drug and biotech companies claiming to have the Next Big Thing in cancer treatment. But all the hype typically amounts to just that. However, a biotech firm in San Diego that has been flying under the radar for the past decade may just have the elusive cure for this insidious disease.


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. 



Cancer survivor James Eldridge
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 interview, 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. 


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. Stay tuned to this national news blog for updates on Genelux.

52 comments:

  1. Wow, thanks for sharing this, Jamie!

    ReplyDelete
    Replies
    1. You are most welcome, Tami. Thanks for reading.

      Delete
  2. Thank you! Think about my sister who just died of pancreatic cancer and all the others before her. Can't wait for this to go mainstream. Appreciate this report. Catherine

    ReplyDelete
    Replies
    1. Thank you Catherine. I am so sorry about your sister. I am told that genelux's animal trial data for pancreatic is very strong. Completely eradicated the cancer in mice. There have been no human trials for pancreatic, yet, but this therapy appears to work for virtually all types of cancer. Stay tuned. And tell a friend. This company needs and deserves the support of the national cancer community.

      Delete
    2. Would this be beneficial to lymphoma patients?

      Delete
    3. Evidently, yes. No human trials, yet, but the animal data for lymphoma is very strong, and the company already has trials underway for this virus-based treatment in canine cancers. They are very confident that this therapy will be very effective in human blood cancers. The company is currently seeking funding for a lymphoma trial.

      Delete
    4. Thanks, Jamie for all your research and efforts in helping cancer patients. I hope that the lymphoma trial will begin soon and that it will be successful. Please keep us posted on any news!

      Delete
  3. Nice article. Thanks... but this virus will take a minimum of 5 to 7 more years of trial development before it comes up for FDA approval. One Phase I/II and three Phase I trials are in process. They then have to run Phase II trials in each indication and finally at least two Phase III randomized trials. If it is really as good as you indicate (and since Sloan Kettering is co-sponsoring a trial, it may be) then 5 years is reasonable. However it is an attenuated (modified) virus so testing and protocols are more comprehensive safety wise than for a non-attenuated product like Reolysin (Deering Strain reovirus) which is in end Phase III testing for Head and Neck Cancer and which also was initially tested by Harrington, Pandah and De Bono in the UK at ICR and for which many trials (app 30 are currently running or have been run over the past 12 years in many indications with significant results obtained). Phase III results for Reolysin are due out this quarter and if statistically significant should put Reolysin on the path for FDA approval in the US in about a year or two and in Europe, Russia and the other former Soviet countries as early as next year. Other viruses ahead of Genelux's virus are Biovex's (Amgen now) melanoma virus drug (OncoVEX GM-CSF modified herpes-simplex 1 virus) and Jennerex's jx-594 (JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) which is in trials for liver cancer, lung, renal cell, head and neck trials and others. There are also other companies working on viral therapies for cancer and the market potential is huge according to Jennerex's Kirn who thinks virotherapy will eventually surpass the market for monoclonal antibodies (many billions per year). So there is a lot to go around and I think all of these virotherapy companys may be winners eventually. I think Amgen will be first to market with their intratumoral melanoma treatment and then Oncolytics Reolysin for multiple cancers. We will see.

    ReplyDelete
    Replies
    1. Thanks for this info, anonymous, most of which I know. I could give you a long explanation as to why genelux's virus-based therapy is preferable and less problematic than some of the others you mention. Suffice to say, I support all of this research you cite and all of these therapies. I do believe it is the future of cancer care, or at least a big part of it. I trust you don't know the history of Jennerex? I certainly hope it doesn't take as long as you suggest for Genelux to get FDA approval, though I know the process is painstakingly slow. The good news is these four Genelux clinical trials are all still open, and I am hoping there are more trials in the offing. Now, since you've put something this specific and detailed on my national news blog, how about you actually tell us who you are?

      Delete
    2. I am a prostate cancer survivor who has been following the field for over 10 years. I have done a lot of investigating into this field. You might say I have a vested interest in this type of therapy if my PC ever returns.
      I don't know much about Jennerex's history except a little about Kirn and Jennerex's therapy from watching his videos on Utube and some articles he's written on virotherapy. I know he is very high on the future of virotherapy.
      I appreciate your article on genelux as I hadn't been too aware of the company - I will follow it closely now. If it works as well as you indicate they could fly through the trials a lot faster than I predicted. Hopefully this will be the case.

      Delete
  4. I am a stage 4 bone marrow cancer survivor who beat the cancer totally naturally in a few months, I have helped many others do the same since. I was diagnosed in 2006 and remain cancer free with a very strong immune system which is imperative to keeping cancer cells in check to this day.

    There have been many natural cancer cures over the years that have been suppressed by the FDA, cancer society, and pharmaceutical companies, I do hope that will not be the case with this one.

    Anyone who is interested in learning what cancer is and what it is not as well as the greed that keeps people sick should read this article. http://mountaingrannysorganicherbs.com/news/2013/03/understanding-not-fearing-cancer/

    Totally detoxing the body so the immune system can function like it should to keep cancer cells carried out of the body, is very important. Here is how I recommend doing that. http://mountaingrannysorganicherbs.com/news/2013/03/proper-cleansing-proper-order/

    Thank you for this wonderful news!

    Tanya Boozer
    Master Herbalist
    Holistic Practitioner

    Disclaimer – It is not the intention of the herbalist to advise on health care. Please see a health professional about any health concerns you may have. These statements have not been evaluated by the FDA. This information is not intended to prevent, diagnose, treat, or cure any disease.

    ReplyDelete
  5. My father had stage 4 cancer and just had it entirely eradicated with this procedure. He was told he may get cancer again, but not the throat cancer he had. It's been completely wiped out from his body. It does work.

    ReplyDelete
    Replies
    1. that is so great to hear. can you please email me privately at jreno@san.rr.com ?

      Delete
  6. "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."

    Interestingly enough, it is up for debate in science whether viruses are actually considered living. Most scientists do not consider viruses to be a living organism, despite the fact that there are many features they have in common with living things.

    It is fascinating, though, to see how tapping into this type of "biological intelligence" can provide much more focused treatment as opposed to essentially a wide scale poisoning of the the body.

    Here's a cool read on the virus debate if you'd like to hear more and how it could potentially relate to this cure.
    http://www.scientificamerican.com/article.cfm?id=are-viruses-alive-2004

    ReplyDelete
    Replies
    1. Thanks for reading, Scott. This is interesting, if somewhat beside the point.

      Delete
  7. Jaime,

    Thank you so much for this article. I hope that this becomes larger than life and becomes a beacon of light for all of those who have felt as if a dark cloud has been cast on their being.

    I know I haven't added much, but I wanted to share my thoughts.

    Mike

    ReplyDelete
  8. Do you have any information about how patients can enroll in trials outside their home country? I'm currently in a trial for a selective inhibitor of nuclear export (SINE) sponsored by Karyopharm Therapeutics, but would probably be eligible for the trial in Germany after a four-week wash-out (I have peritoneal disease, recurrent low-grade ovarian cancer with both a KRAS and NRAS mutation).

    I've known of people who've enrolled in trials in other countries, but have no idea how one would go about it. What costs are covered by the drug company? I assumed that any treatment/testing related to the trial would be covered by the drug company, but when I contacted Dr. Lauer at University Hospital Tuebingen, he indicated that it would be a problem that I don't have German health insurance.

    Can you offer any advice, Jamie?

    ReplyDelete
  9. Thanks, he was unable to answer my questions and forwarded my email to Dr. Yu. I'll provide an update here once I find out more information about the feasibility of enrolling as a foreign patient.

    ReplyDelete
    Replies
    1. thanks, please keep me posted.

      Delete
    2. Hi Alicia, have you made any progress on this? And if so, please post an update here and let us know. Thanks!

      Delete
  10. Jamie really enjoyed your article on Genelux. I made a sizable investment in Genelux back in 2005 and have closely followed their progress. To my knowledge no other company in history has the positive human clinical results that Genelux achieved. What is truly puzzling is the absolute lack of press Genelux has received. Do you have any insight on why this may be?

    ReplyDelete
    Replies
    1. This comment has been removed by the author.

      Delete
    2. Thanks anonymous. Please contact me privately at jreno@san.rr.com, would be happy to talk to you. As I point out in the story, the company is very conservative and close to the vest. They just want to do everything right, no hype. My story is one of the first for which they agreed to talk on the record. I really respect Genelux's CEO, and I do think he is beginning to realize that it is time for the company to reach out to the public and open up a bit more to the media.

      Delete
  11. Jennerex, Amgen, and Oncolytics Biotech have reported serious progress with oncolytic viruses of late. I'm heavily invested in the latter. (I'd love to own a piece of Jennerex, but it's not publicly traded.) The Oncolytics Biotech phase 3 stage 1 results in Head & Neck cancer are due out in September 2013, and there are 6 randomized phase 2 studies coming in behind that, all externally sponsored by the NCI and NCIC. Based on the preliminary results of existing trials, I expect that all three of these companies will get product approval for their respective viruses. Since the side effect profiles are minimal, these treatments are ideal for combination therapy, eliminating worries of direct competition from any other product.

    ReplyDelete
    Replies
    1. Jennerex, as you may already know, received bad news this week.

      Delete
    2. Yes, I tweeted about it this morning... http://www.bizjournals.com/sanfrancisco/blog/biotech/2013/09/jennerex-transgene-immunotherapy-liver.html

      Delete
  12. Thanks "anonymous." Without getting into a lot of detail, I have studied all the trials and all the companies that are studying virus-based cancer therapies. I'm keeping a close eye on them all, and many are indeed promising, including Amgen's T-Vec trials for skin cancer http://www.thestreet.com/story/11938587/1/asco-13-amgens-cancer-killing-virus-shows-skin-cancer-survival-trend.html . Having said that, I believe Genelux has the best therapy, by far. If you read the results from the other clinical trials, they aren't nearly as impressive as the Genelux results. Most of the other viral therapies target just one form of cancer, or they have side effects, or are just ineffective. But I would think and hope that there is room for all of these options for cancer patients.

    ReplyDelete
  13. I have a Question word it work on Osterscarcoma my son has been fighting it for 2 years it started in his leg and now its in his Rt lung we are currently going to MD Anderson he was 14 when we found out he is 16 now i just wish i son could be normally again

    ReplyDelete
    Replies
    1. Hi Andy, the early animal trials eradicated cancer in just about every human cancer. For more info feel free to contact Tim Wilson, Genelux adviser, at doctor@san.rr.com .

      Delete
  14. Would the Genelux therapy be effective against Chronic Lymphocytic Leukemia? I have been diagnosed with that and my periodic blood "numbers" have all been trending in a bad way.

    ReplyDelete
    Replies
    1. Vince, it appears to be very effective in blood cancers, including leukemia and lymphoma. But to get more info about that contact Tim Wilson, Genelux adviser, at doctor@san.rr.com . Tell him I sent you.

      Delete
    2. sorry, it's docteur@san.rr.com

      Delete
    3. I am a shareholder in this company and it is showing great promise. I just wish for everyone that has cancer it would move faster to getting FDA approval

      Delete
    4. i share your wish. this is a remarkable treatment, but i fear that the company's deep reluctance to do any public relations, its apparent disdain for and distrust of the media, could work against them. there are really good, dedicated people running genelux, but it is time for this company to pull back the curtain and let the world know what they are doing.

      Delete
    5. I am also a shareholder of this company. The company's reluctance to do public relations I feel is based on the fact that they want to keep the window between the knowledge of their product and FDA approval as short as possible. The clinical trials results are unprecedented and will only continue to impress the clinical doctors as they progress. The clinical trial at Sloan Kettering in New York is the key to FDA approval for Genelux.

      The problem is if Genelux comes forward to soon with the results of their product prior to FDA approval many desperate individuals with cancer will overwhelm the management at Genelux who have limited personnel to respond to those afflicted. This is a lousy situation to put the company in prior to FDA approval. Dr. Szalay does not want Genelux to be just another "We have the cure for cancer" company, which is in a marketplace already crowded with many other companies claims. How many times over the past 40 years have we heard this claim from other companies!! People at this point are very skeptical of anyone claiming a cure. Dr. Szalay is a fervent believer in letting the trial results speak for themselves. I personally believe this is the future therapy for many if not all cancers. Jamie how would you recommend Genelux proceed regarding the media?

      Delete
    6. Interesting take. First, please consider identifying yourself. Anonymity leads to suspicion. As a stock holder, what do you have to hide? I do not for a second buy the argument that "many desperate individuals with cancer would overwhelm" the management at Genelux. What would really happen if the good folks at Genelux came out of the weeds, stepped onto main street and willingly became a part of the American conversation on cancer? Their credibility would soar, as would their chances of FDA approval, which sadly are slim at this point. We all know who runs the FDA. It is big pharma. Genelux is a huge threat to the status quo, to the multi-billion dollar cancer industry. But it would be much harder for FDA to say no to a company if the nation - namely cancer patients and their loved ones - knew how well its product worked. It's human nature. These human trials are still early, but they are beyond promising. I respect that Dr. Szaalay is a firm believer in letting the trial results speak for themselves. But right now, NO ONE is speaking. These trial results can;t speak. They remain unseen and unknown to the general public. I understand that they do not want to overhype this as "the next cure." But right now the public simply doesn't have the option to decide because they have never even heard of Genelux. This is in my opinion a gargantuan marketing mistake. It's not unlike the modern motto for academics: "publish or perish." In the Genelux case it is "publicize or perish." The key is to be very smart with the media. To find voices in the media and in the nationwide cancer patient advocacy communities that are reasonable and who are not beholden to big pharma. Voices like me who recognize and seek out new, less toxic cancer treatments for patients. Play it smart, but play the game. Or, the game will be over.

      Delete
    7. Jamie, Dr. Szalay is no longer with Genelux. As an initial investor in this company, I am ecstatic that there is finally an actual management team in control rather than one man who ran Genelux like his own little fiefdom. I believe one of the reason Genelux has stayed under everybody's radar was due to the secretive nature of Dr. Szalay and his desire to control the company completely. He would not even discuss anything with the board or us shareholders. Sorry that I do not divulge my identity but I have no desire to come into Dr. Szalay's crosshairs. I know many people that have and it has not been pretty. It will take some time to right the ship but look for favorable news in about a year, or hopefully sooner.

      Delete
    8. I know, thanks. The company is in better hands now than ever.

      Delete
    9. This comment has been removed by the author.

      Delete
    10. You both don't have a clue as to what you are talking about. The truth will soon be revealed about the people who have taken over (only for monetary gain) as opposed to Szalay's main interest of helping people; you'd better check on all the lawsuits now in progress.

      Delete
    11. Steffani Proffit, the truth may soon be revealed? You're joking, right? Are you aware of what Dr. Szalay was doing while at Genelux? You are the one who doesn't know what you are talking about. The company is now in much better and much more ethical hands. If you don't believe that, then you must have some sort of personal connection to Dr. Szalay, yes? Please have the courage to identify yourself and tell us why you are making these irresponsible and inaccurate statements about the new leadership at Genelux.

      Delete
  15. This comment has been removed by a blog administrator.

    ReplyDelete
  16. OncoWell is a healthcare company committed to supporting the wellness of cancer patients.
    Cancer and the side effects chemotherapy or radiotherapy can have a devastating impact on
    the body. Oncowell provides access to the highest quality complementary therapies to support
    the body during this traumatic time.
    - See more at: cancer Treatment

    ReplyDelete
    Replies
    1. Please do not shamelessly advertise your products on my national news blog. Thanks.

      Delete
  17. I am a blogger searching for quality information from a long time.

    ReplyDelete
  18. hey my relative is suffering from adenocarcinoma gall bladder cancer which is metastatic and nonsurgical.Please reply if the treatment can help us.Also state possible trials in my case.

    ReplyDelete
  19. lookout Genelux is about to make some big announcements for 2015 www.genelux.blog.com

    ReplyDelete
    Replies
    1. Thanks for this note. I'm very aware of what Genelux is currently doing, and it is indeed very exciting and promising. Quick request: please consider posting using your name. Anonymous posts carry very little weight or credibility on this news blog. I generally delete anonymous posts but will keep this up. Thanks.

      Delete
  20. Hi any updates on this treatment. Thanks

    ReplyDelete
  21. Cook at Foods to Avoid During Cancer Treatment foods.
    These are some great tips. For those who could use some more specific advice, tips and information about great article thanks for posting.

    ReplyDelete