Hemipsherx and Chronix file patent for CFS blood test

[LaurelW]

CHRONIX BIOMEDICAL AND HEMISPHERX BIOPHARMA JOINTLY FILE PATENT APPLICATION FOR A BLOOD TEST FOR CHRONIC FATIGUE SYNDROME (CFS)
- CHRONIX TECHNOLOGY FOCUSES ON CHANGES TO CFS PATIENTS ' DNA -
- HEMISPHERX AND CHRONIX PLAN STUDIES TO VALIDATE TECHNOLOGY AS A POTENTIAL DIAGNOSTIC TEST FOR CFS-

San Jose, CA, March 3, 2011 - Chronix Biomedical ("Chronix") announced today that it filed a provisional United States patent application jointly with Hemispherx Biopharma, Inc. (NYSE Amex:HEB) ("Hemispherx") on a blood test for Chronic Fatigue Syndrome ("CFS"). Patients with CFS exhibit a wide range of disabling symptoms including the inability to overcome fatigue by rest, swollen lymph nodes and cognitive deficiencies. CFS is estimated to affect approximately 4 million Americans, according to the Centers for Disease Control and Prevention (CDC). The disorder has a negative economic impact in the United States estimated at more than $9 billion annually.

The Chronix experimental approach analyzes fragments of DNA often released into the bloodstream during the process of apoptosis or programmed cell death. Chronix is using its proprietary technology and advanced DNA sequencing platforms to measure alterations in specific regions of the chromosome, which can be detected as distinctive "signatures" in cell-free blood-borne DNA. By focusing on these signatures, Chronix's technology can detect the presence of disease-damaged cells in simple blood samples without needing to biopsy diseased cells or tissues.

"Our technology-based on DNA released into the bloodstream by dying and damaged cells-taps into the dynamic information provided by the genomic alterations unique to each diseased cell. We capture what is happening to the DNA very early in and throughout the disease process, in real time, and patient by patient. That's how our approach differs from other tests that focus on static genomic data or protein biomarkers," said Dr. Urnovitz. The patient-unique signatures captured by the Chronix technology may prove useful as a companion diagnostic - a test that is used to help guide treatment decisions - and to provide information about the disease process to help pharmaceutical companies select the most efficacious drug candidates.

Use of the Chronix diagnostic technology in CFS will be evaluated in a study being planned by Chronix and Hemispherx, a leader in CFS pharmaceutical research. Dr. William Carter, Hemispherx CEO, commented, "It is with great enthusiasm that we will be conducting studies aimed at validating the utility of the Chronix technology to identify how different individuals can respond to Hemispherx's experimental drug Ampligen."
The Chronix Biomedical blood test for Chronic Fatigue Syndrome is experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.

 

[August59]

Well!! Not sure what to think?

 

[dannybex]

Bizarre...

Why isn't Hemispherx proceeding with their phase III trials of Ampligen that they've been talking about for more than a year now?

They keep releasing the same press release over and over for the last 16 months:

http://www.marketwatch.com/story/10-qa-hemispherx-biopharma-inc-2011-02-14-622460

"On November 25, 2009, we received a Complete Response Letter ("CRL") from the FDA which described specific additional recommendations related to the Ampligen(R) NDA. In accordance with its 2008 Complete Response procedure, the FDA reviewers determined that they could not approve the application in its present form and provided specific recommendations to address the outstanding issues.

We have carefully reviewed the CRL and will seek a meeting with the FDA to discuss its recommendations upon the compilation of necessary data to be used in our response. We intend to take the appropriate steps to seek approval and commercialization of Ampligen(R). Most notably, the FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen(R) and recommended at least one additional clinical study which shows convincing effect and confirms safety in the target population. The FDA indicated that the additional study should be of sufficient size and sufficient duration (six months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. We are presently planning a confirmatory clinical study which will utilize the same primary endpoints as our earlier studies but with an enlarged number of subjects to potentially achieve a more representative statistical model. "

This "news" was first released back in December 2009.

 

[leaves]

I won't hold my breath...

 

[richvank]

Hi, all.

I think this is a very interesting development. I don't know the details of the techniques used by Chronix Biomedical to characterize the cell-free DNA, but Howard Urnovitz has several published papers on this, involving diseases in animals and humans.

For those of us who have been involved with the research into CFS and Gulf War Illnesses for a few years, the name Howard Urnovitz is familiar. He has taken some very controversial positions in the past, but he appears to me to be onto something here. Getting together with Hemispherx, which has been trying to get Ampligen approved for many years, is also an interesting twist.

Here is the rationale for why I think the type of thing they are proposing might pay off:

It is known from published studies that cells in CFS have a higher than normal rate of apoptosis, i.e. programmed cell death. For example, Vojdani and coworkers showed this to be true of neutrophils, the most abundant type of white blood cells.

Normally, DNA is located inside the nucleus of the cell. However, when cells die by apoptosis, some of their DNA is released to the blood as cell-free DNA.

It is known from the work of Dr. John McLaren Howard at Acumen Lab in the UK that the level of cell-free DNA is elevated in CFS, and that is consistent with the elevated rate of apoptosis.

It seems likely that the cells that die early in CFS must have something specifically wrong with them, or at least more wrong than the cells that don't undergo apoptosis as soon. Could it be the presence of the XMRV virus? If so, since XMRV is a retrovirus, its complementary DNA would be inserted into the cell's DNA, and it seems possible that it would show up in the cell-free DNA that results from apoptosis of infected cells.

I haven't always agreed with Howard Urnovitz's thinking, which is usually quite "outside the box," but I think this is something to watch.

Best regards,

Rich

 

[JohnnyD]

Why isn't Hemispherx proceeding with their phase III trials of Ampligen that they've been talking about for more than a year now?

They are. But the CRL and the WPI Science paper were released at about the same time. Hemispherx would be derelict not to take XMRV into account before filing formal protocols. Retrospective XMRV testing of the 516 trial is being done by WPI. Formal protocols were filed in late November.

 

[justy]

Thanks for your take on this Rich. I have had the testing at the Acumen lab which showed i had a high cell free DNA result, along the lines of a chemo patient. I have often wondered what was specifically going on with these cells. I have tried googling cell free DNA and disease but you get very little back apart from a few research papers relating to cancer. I am no scientist so have struggled to understand this area at all. Any more info on what is going on here with programmed cell death would be very interesting and possibly quite enlightening.

 

[dannybex]

Retrospective XMRV testing of the 516 trial is being done by WPI. Formal protocols were filed in late November.

Thanks Johnny. I still don't understand why they don't talk about this in their latest (February) press release.

 

[determined]

I think this is a very interesting development.

I think this is really interesting and potentially very important as well. When I saw this, I immediately connected this to my symptoms of what seem like gout....if I am breaking down a lot of DNA, there will be more purines to break down. Purines, along with pyrimidines, make up part of each subunit of strands of DNA. Gout is a disorder characterized by high levels of the end product of purine breakdown. Hmmm.

 

[aquariusgirl]

Justy. ..my cell free DNA from acumen was high too. Maybe 19 or 20.
what was yr number?

Rich, this test would potentially be a useful biomarker, but does it have any value in terms of treatment?

thanks

 

[SpecialK82]

Thanks Rich for the insight into cell apoptosis - It makes sense then that we would have more cell free DNA, do you know if mainstream medicine accepts an increased cell free DNA test as credible proof that there is an illness of some kind going on?

By the way, I have a reliable source telling me that Hemispherx is meeting with providers and potential providers of Ampligen this weekend. They will be educating the doctors on the new Phase III protocal.

 

[JohnnyD]

Thanks Johnny. I still don't understand why they don't talk about this in their latest (February) press release.

Danny, some of it was included in last November's PR, here:

http://hemispherx.com/content/investor/default.asp?goto=690

But they also give additional information in conference calls not in PRs, like projected timelines. For example in the December (or maybe November) CC they mentioned that WPI testing was currently delayed about three weeks because WPI was moving their labs.

By the way, I have a reliable source telling me that Hemispherx is meeting with providers and potential providers of Ampligen this weekend. They will be educating the doctors on the new Phase III protocal.

I've heard this too.

 

[alex3619]

I think this is a very interesting development.

I think this is really interesting and potentially very important as well. When I saw this, I immediately connected this to my symptoms of what seem like gout....if I am breaking down a lot of DNA, there will be more purines to break down. Purines, along with pyrimidines, make up part of each subunit of strands of DNA. Gout is a disorder characterized by high levels of the end product of purine breakdown. Hmmm.

Hi determined, thank you for this post. One of my alternative diagnoses in the early days was gout, due to elevated uric acid levels, the end product of purine breakdown. This was eventually eliminated as a diagnosis, despite continued high levels of uric acid. This is only anecdotal of course, but still interesting. Bye, Alex

 

[JohnnyD]

http://www.businesswire.com/news/ho...al-Launch-Cancer-Detection-Monitoring-Service

Re: Mikovitz comment about how ampligen activates xmrv in about 30% of patients, some % benefit and some % no change. I think Hemispherx will use this test to identify and monitor and distinguish those that benefit from ampligen, or may need a combo therapy.. in their new phase 3.

"The initial focus of the Chronix Apoptotic Serum DNA Testing Service is to offer researchers an affordable and reliable tool providing early information on the cancer status of patients in their clinical trials. In addition, because the Chronix technology can pinpoint specific DNA-related damage to the patient’s cells, this “personalized medicine” approach may make it possible to analyze each patient’s profile and then to match those profiles to treatment outcomes. These analyses could provide rapid feedback to researchers on the likely efficacy of treatment options and could potentially serve as surrogate biomarkers of the efficacy of different treatments."