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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« NeuroSearch's Decline | Main | Good News in Oncology: More Immune Therapy for Leukemia »

March 22, 2013

Good News in Oncology: Oncolytic Virus Therapy

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Posted by Derek

The last few days have brought some good news on some unusual approaches to cancer therapy. First off was Amgen's report that they'd seen positive results in advanced melanoma using a modified HSV treatment. This is technology that they brought in by buying Biovex in 2011, and as a minor side effect, if it works, it'll be so much the better for Roger Perlmutter (now at Merck), since this was a deal made under his watch.

Specifically, the company says that 16% of patients showed a response (durable response rate, DRR) to the treatment, versus 2% of the control group. That's encouraging, but the big question is overall survival. DRR will get you little or nothing at the FDA, or shouldn't, if people don't actually live longer. We should have those numbers later this year - considering what sort of shape people are in with late-stage melanoma, you can look at the odds two different ways. The disease is so advanced, perhaps, that it'll be difficult for anything to show a benefit. Or, on the other hand, anything that doe have an effect will stand out, since the control group's course will be so relentless.

I hope this works, both for the patients and for the idea of using a virus to attack cancerous cells. That one's been kicking around for a long time, with several companies in the chase, and it has a lot of appealing features. But it also has a lot of tricky details, too - targeting the tumor cells over normal ones, finding the appropriate viral platform, delivering it safely to the patient, and more. There's also the question of whether you just want to lyse the tumor cells with a viral load, or also make them express some therapeutically useful protein. The Amgen/Biovex HSV virus in this latest trial, for example, also causes the cells to express GM-CSF for an additional immune response (with the control group getting GM-CSF alone).

So even though this has been actively researched in humans since the mid-1990s, I'd still call it the early days. Here's hoping for more encouraging news, from Amgen and the others in this chase.

Comments (7) + TrackBacks (0) | Category: Cancer | Clinical Trials


COMMENTS

1. Dr Jimbo on March 22, 2013 7:31 AM writes...

Nice to see some developments in this area. I included oncolytic viruses as potential future therapy in my pharmacology lectures to medical students a few years ago - perhaps they will retrospectively consider me a little less crazy now.
By now, anyone who saw 'I am Legend' has probably forgotten that cancer-curing viruses were the cause of the trouble in that film, so that will make the PR a bit easier.

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2. alig on March 22, 2013 7:49 AM writes...

So they use GM-CSF as the control arm, but now Yervoy or Zelboraf are the standard of care. Both of those drugs were able to show improvements in overall survival partially because the previous standard of care was useless. So this brings up an ethical question, if the standard of care changes during your trial, is it ethical to keep the control arm on an inferior treatment to the new standard? While it will complicate your trial analysis, do not those patients deserve the best treatment approved? Also while safe and effective are what the FDA is supposed to look at, they seem to considered better than standard of care in approvals recently.

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3. Ken on March 22, 2013 5:09 PM writes...

Unless I'm mistaken, they are injecting the drug (oncolytic virus) directly into the tumor. That's fine for some subcutaneous tumors, but what about those that we cannot find on the surface of the skin (most tumors) or those that metastasize to vital organs? Why not just inject poison directly into the tumor. One could imagine the same efficacy.

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4. Andy on March 23, 2013 12:08 PM writes...

So this brings up an ethical question, if the standard of care changes during your trial, is it ethical to keep the control arm on an inferior treatment to the new standard?

Presumably you're talking about patients already enrolled in a blinded study where patients don't know what arm they are on, since you can't force anyone to stay on study. Even for the blinded studies, patients are usually "off study" upon evidence of disease progression (with some exceptions for immunomodulatory therapies) so they are able to get the new standard of care once it is established that the experimental therapy isn't working. If you don't offer at least standard-of-care in the control arm you won't be able to accrue patients to the study, which may merit a re-design if the study is halfway through enrollment when the standard of care changes.

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5. jose fontanals on April 25, 2013 12:18 PM writes...

Please send mi ifomation about protocols ,and how to get thi therapy

Permalink to Comment

6. Tanny on July 23, 2013 1:24 PM writes...

GL-ONC1 a virus made by Genelux Corporation -- eradicates tumors - inject into bloodstream - kills CTC's, mets, tumors and stem cells throughout the whole body. Amgen bought the HSV which is not very effective and cant be injected systemically due to inherent dangers.

Genelux published eradication data in 2007

Permalink to Comment

7. Trojan1990 on December 13, 2013 11:04 PM writes...

Cancer is done. Genelux has the answer. Investigators at Royal Marsden, Tubingen, Sloan Kettering and UC San Diego know the truth. GL-ONC1 kicks cancer's ass. Most common side effect is Pyrexia (fever). CTC's eradicated in just over a week. Effective on scores of different types of cancer. Tanny speaks the truth.

By the way, you can also attach your favorite VEGF to it and extend patent coverage. Paging Roche/Genentech.

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