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CMX001 will be out in 2012...?


Epoh

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Hey--they're in phase 3 trials and are likely to be fast tracked because of it's potential military usage so you never know. Lots of drugs get cleared for emergency use during phase 3. I just wish they were more interested in treating HSV with it. Even if it does go to market soon, the chances of finding an amenable doctor to prescribe it off label are pretty slim. Guess I'll just have to look into contracting smallpox....

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Just another few years of testing for approval. Actually, I did ask to be included in the current trial as they claim they are testing it against 12 different virus families--they have no interest in HSV, only "life threatening" illnesses. My new plan is to try to buy bavituximab from the outside labs making it for peregrine's research--one in FL, some in China--where maybe regulations are not so strict. I'm so willing to be a guinea pig...

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petition

Just another few years of testing for approval. Actually, I did ask to be included in the current trial as they claim they are testing it against 12 different virus families--they have no interest in HSV, only "life threatening" illnesses. My new plan is to try to buy bavituximab from the outside labs making it for peregrine's research--one in FL, some in China--where maybe regulations are not so strict. I'm so willing to be a guinea pig...

Should we create a petition for them to test for hsv? Have you signed the peregrine petition?

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On their website they mentioned:

Improved Potency Demonstrated in Preclinical Studies

The antiviral activity of CMX001 has been characterized in both in vitro and in vivo studies. In cell culture assays, CMX001 is significantly more active than cidofovir against double-stranded DNA viruses including orthopoxviruses (variola, monkeypox, vaccinia, cowpox, and ectromelia), herpes viruses (CMV, herpes simplex virus (HSV)-1,-2,-6, -8, HSV-2, varicella zoster virus (VZV), Epstein-Barr virus (EBV), and multiple adenoviruses. Against variola major, CMX001 is approximately 250 fold more potent than cidofovir in inhibiting viral DNA replication.

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I fount this new article:

RESEARCH TRIANGLE PARK, N.C., Feb. 16, 2011 /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing orally available antiviral therapeutics, today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Chimerix's broad spectrum antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.

CMX001 is a potential dual-use therapeutic with evidence of antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause morbidity and mortality in humans, including smallpox. Under the terms of the BARDA contract, Chimerix will receive committed funding of $24.8 million during the first year with subsequent option periods that, if completed, would bring the total contract value to $81.1 million.

The funding from BARDA builds upon the $37 million Chimerix previously received from the National Institute of Allergy and Infectious Diseases (NIAID) for development of CMX001 for smallpox, in addition to substantial private investment from top-tier venture capital firms for the development of CMX001 as a treatment for other life-threatening infections such as adenovirus and cytomegalovirus.

As part of progressing the clinical and non-clinical development of CMX001 for the smallpox indication, the BARDA contract will also support expanded human safety trials and the recently initiated CMX001-350 multicenter, open-label clinical study of CMX001 for the treatment of twelve life-threatening or serious conditions caused by dsDNA viruses. This represents Chimerix's first contract with BARDA and will position CMX001 for possible procurement as a medical countermeasure for the Strategic National Stockpile.

"The activities undertaken as part of the BARDA contract will provide significant value to Chimerix's overall development program for CMX001 for the prophylaxis, preemption and treatment of life-threatening or serious viral infections in immunocompromised patients," said Kenneth I. Moch, President and Chief Executive Officer of Chimerix. "We look forward to working with BARDA to harness the full potential of CMX001 to address the biodefense threat represented by smallpox."

"BARDA's support of the advanced development of CMX001 and their recognition of the role that Chimerix has in helping to assure the Nation's medical preparedness is an important step in addressing the threat of a smallpox attack," said George Painter, Ph.D., Chairman and Chief Scientific Officer of Chimerix. "Chimerix is fully committed to addressing unmet medical needs that have biodefense and global public health implications, especially for the most vulnerable groups in our population including children and the immunocompromised. We look forward to working collaboratively with BARDA to progress CMX001."

About Chimerix and CMX001

Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.

The company's lead candidate, CMX001, is being developed as a potential broad spectrum antiviral agent for the treatment of life-threatening double-stranded DNA (dsDNA) viral diseases. Over 350 people have received CMX001 to date, with a growing body of evidence supporting the drug's antiviral activity in humans.

Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of cytomegalovirus (CMV) in hematopoietic stem cell transplant patients (CMX001-201), a Phase 2 study being initiated for the treatment of adenovirus (AdV) infection in pediatric and adult hematopoietic stem cell transplant patients (CMX001-202), and an Open-Label Study (CMX001-350) for the treatment of any of 12 different dsDNA viral infections, including AdV, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses. The Open-Label Study builds on Chimerix's extensive experience working with clinicians at over 55 leading institutions in the United States, Canada, Europe and Israel who have sought CMX001 for the treatment of more than 150 immunocompromised patients under Emergency INDs. CMX001 has been well tolerated in all studies.

CMX001 is also being developed as a medical countermeasure in the event of a smallpox release. Chimerix has received significant federal funding for the development of CMX001 as a medical countermeasure against smallpox from the National Institute of Allergy and Infectious Diseases under Grant No. UO1-AI057233 in addition to new funding from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C.

Chimerix's second clinical-stage antiviral compound, CMX157, a potent nucleoside analogue with in vitro activity against HIV and hepatitis B, has the potential to directly address several limitations of current HIV therapies. Chimerix is developing CMX157 for the treatment of HIV infection including those caused by multi-drug resistant viruses. A Phase 1 clinical study has been completed demonstrating that the compound is well tolerated and that the active antiviral, TFV-PP, was measurable in peripheral blood mononuclear cells (PBMCs) after a single dose and remained detectable for six days, indicating that it may be suitable for once-weekly dosing.

Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, flu, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com.

SOURCE Chimerix, Inc.

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I fount this new article:

RESEARCH TRIANGLE PARK, N.C., Feb. 16, 2011 /PRNewswire/ -- Chimerix, Inc., a pharmaceutical company developing orally available antiviral therapeutics, today announced that it has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Chimerix's broad spectrum antiviral drug candidate, CMX001, as a medical countermeasure in the event of a smallpox release.

CMX001 is a potential dual-use therapeutic with evidence of antiviral activity against all five families of double-stranded DNA (dsDNA) viruses that cause morbidity and mortality in humans, including smallpox. Under the terms of the BARDA contract, Chimerix will receive committed funding of $24.8 million during the first year with subsequent option periods that, if completed, would bring the total contract value to $81.1 million.

The funding from BARDA builds upon the $37 million Chimerix previously received from the National Institute of Allergy and Infectious Diseases (NIAID) for development of CMX001 for smallpox, in addition to substantial private investment from top-tier venture capital firms for the development of CMX001 as a treatment for other life-threatening infections such as adenovirus and cytomegalovirus.

As part of progressing the clinical and non-clinical development of CMX001 for the smallpox indication, the BARDA contract will also support expanded human safety trials and the recently initiated CMX001-350 multicenter, open-label clinical study of CMX001 for the treatment of twelve life-threatening or serious conditions caused by dsDNA viruses. This represents Chimerix's first contract with BARDA and will position CMX001 for possible procurement as a medical countermeasure for the Strategic National Stockpile.

"The activities undertaken as part of the BARDA contract will provide significant value to Chimerix's overall development program for CMX001 for the prophylaxis, preemption and treatment of life-threatening or serious viral infections in immunocompromised patients," said Kenneth I. Moch, President and Chief Executive Officer of Chimerix. "We look forward to working with BARDA to harness the full potential of CMX001 to address the biodefense threat represented by smallpox."

"BARDA's support of the advanced development of CMX001 and their recognition of the role that Chimerix has in helping to assure the Nation's medical preparedness is an important step in addressing the threat of a smallpox attack," said George Painter, Ph.D., Chairman and Chief Scientific Officer of Chimerix. "Chimerix is fully committed to addressing unmet medical needs that have biodefense and global public health implications, especially for the most vulnerable groups in our population including children and the immunocompromised. We look forward to working collaboratively with BARDA to progress CMX001."

About Chimerix and CMX001

Chimerix is developing novel antiviral therapeutics with the potential to transform patient care in multiple settings, including transplant, oncology, acute care and global health.

The company's lead candidate, CMX001, is being developed as a potential broad spectrum antiviral agent for the treatment of life-threatening double-stranded DNA (dsDNA) viral diseases. Over 350 people have received CMX001 to date, with a growing body of evidence supporting the drug's antiviral activity in humans.

Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of cytomegalovirus (CMV) in hematopoietic stem cell transplant patients (CMX001-201), a Phase 2 study being initiated for the treatment of adenovirus (AdV) infection in pediatric and adult hematopoietic stem cell transplant patients (CMX001-202), and an Open-Label Study (CMX001-350) for the treatment of any of 12 different dsDNA viral infections, including AdV, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses. The Open-Label Study builds on Chimerix's extensive experience working with clinicians at over 55 leading institutions in the United States, Canada, Europe and Israel who have sought CMX001 for the treatment of more than 150 immunocompromised patients under Emergency INDs. CMX001 has been well tolerated in all studies.

CMX001 is also being developed as a medical countermeasure in the event of a smallpox release. Chimerix has received significant federal funding for the development of CMX001 as a medical countermeasure against smallpox from the National Institute of Allergy and Infectious Diseases under Grant No. UO1-AI057233 in addition to new funding from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C.

Chimerix's second clinical-stage antiviral compound, CMX157, a potent nucleoside analogue with in vitro activity against HIV and hepatitis B, has the potential to directly address several limitations of current HIV therapies. Chimerix is developing CMX157 for the treatment of HIV infection including those caused by multi-drug resistant viruses. A Phase 1 clinical study has been completed demonstrating that the compound is well tolerated and that the active antiviral, TFV-PP, was measurable in peripheral blood mononuclear cells (PBMCs) after a single dose and remained detectable for six days, indicating that it may be suitable for once-weekly dosing.

Led by a world-class antiviral drug development team, Chimerix is also leveraging the company's extensive chemical library to pursue new treatments for hepatitis C virus, flu, malaria and other global public health needs. For additional information on Chimerix, please visit http://www.chimerix.com.

SOURCE Chimerix, Inc.

So, they are in Phase II for testing - including herpes... (right)?

"Clinical studies of CMX001 include an ongoing Phase 2 study of the prevention/control of cytomegalovirus (CMV) in hematopoietic stem cell transplant patients (CMX001-201), a Phase 2 study being initiated for the treatment of adenovirus (AdV) infection in pediatric and adult hematopoietic stem cell transplant patients (CMX001-202), and an Open-Label Study (CMX001-350) for the treatment of any of 12 different dsDNA viral infections, including AdV, herpes viruses such as CMV, herpes simplex virus and Epstein Barr virus, polyoma viruses such as BK virus and JC virus, and pox viruses"

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I think some drugs are in Phase II & others are in Phase III, They are also doing different tests in controlled groups for Phase II and Phase III, I also believe they are doing some tests in Phase I as well. It is hard to tell, but we probably wont see any real clear understanding until at least late this year. The really good news in my opinion is all the funding they are receiveing, I can think of no other Herpes related drug that has and is receiving this much funding, so I expect that this will either be the first or one of the first new Herpes drugs to hit the market, this is all ofcourse if it is ultimately succesful. Just cross your fingers.

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The Open Label study is for serious infections and if someone has encephalitis caused by herpes simplex, or has shown resistance to currently available antivirals and has a severe ob, they could qualify. The current intent with this drug is for severe cases, however, it is a broad spectrum antiviral. It may be suitable for daily treatment eventually and is superier to Valtrex. But, this will not cure HSV LATENT virus. It can only control ob's and shedding, maybe at 100%. This drug is being sought by many other sufferes of CFS, MS, and Epilepsi. So, I really think CMX001 will become a standard antiviral. I dont't see it happening in 2012 though. They need a few more years to prove that it is safe.

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  • 1 year later...

Can someone create a petition for CMX001 to do testing for HSV we could use a better safer drug!

Would be nice not to worry about shedding and spreading this disease.

Im ready to sign!

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They are doing more testing. There is a clinical trial where they will be recruiting babies born with neonatal herpes soon. CMX-001 has also been fast tracked, however I believe the drug will be stockpiled in case of a small pox terrorist attack or other type of thing. I also supsect it will only be available for serious cases for many years. At some point and time the drug should become available to all as other drugs are currently being developed for terrorist attacks or pandemic illnesses, and eventually what they stock pile will go bad if it isn't used. AIC-316 is looking really good and is meant for regular antiviral use for HSV, plus having two therapeutic vaccines in clinical trials are looking good as well. Just think, even if we can't get 100% suppression from the vaccines/drugs, we may get it by doing both. Lets cross our fingers and hope for the best.

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      Hey @WilsoInAus ok thank you, I will do my best to move on and stop trawling forums haha. 
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      Hey @sgt98 but there is no feasible infection or outbreak to suppress and antivirals do not suppress an initial outbreak in any event 
    • sgt98
      Thanks @WilsoInAus I understand apologies for this but the only other thing I am worried about is that I did take a course of Famvir on day 1 as I felt like I was having an outbreak of cold sores and am worried that has suppressed the initial outbreak genitally 
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      Hi @sgt98 it is not feasible to obtain a HSV-2 infection from receiving oral sex - only HSV-1 is feasible but you've already got that and immunity from any further infection with HSV-1. You do not need any further tests for HSV. You're feeling regret, try to forgive yourself and calm down, let the rational take over. You know the answer here and it won't be long until you believe it too.
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      Hi @NerdP423 and welcome to the website. You raise a lot of points and I think the best way to address your concerns is add some comments at each key point. I've copied your note again below and added these comments in square brackets. I appreciate any insight (even speculation) as to what has been going on with me. I'm a 37y/o M. I last was intimate with a new partner on 2/11/2022, and a few days later started having a huge amount of discomfort in my face. [The first thing that happens though is that herpes causes lesions or at least some skin based disruption. Other symptoms are then related to the actions of the immune system responding to the virus. Without lesions, it is highly questionable that the ailment is related to herpes, yet testing is useful if you have concerns as you have done so.] About a month after that [herpes causes issues within days, if the first 'symptoms' are a month later - its extremely unlikely they are related to herpes], significant discomfort downstairs, however every test I have ever taken for HSV 1 and 2 has been negative. Here are the details: Face: Previously, some significant tingling and itching on the right side of my mouth, lips and chin (still there, but milder) [herpes does not cause general tingling and itching, it can cause a reasonably concentrated feeling of itch/throb from which a herpes lesion appears within hours]. Occasional hot flashes near my right eye, cheek and ear [herpes does not do this, it may be a immune response to something, or stress]. Sometimes it will feel like the skin is crawling on the right side of my face [herpes does not cause a general crawling sensation]. Never seen anything that looked like a traditional cold sore [that's extremely telling, even people with associated atypical symptoms will have experienced herpes lesions]. Occasionally, the left side of my face will have a momentary feeling of skin crawling, but it's so mild that I am not really worried about it. Downstairs: Thankfully, most of these are now milder than they were before. Occasional momentary pinch of pain at the base of my genitals. [herpes does not cause a general pinch feeling.] Aching pain in my boxer area (groin, leg folds) [nor this] Occasional feeling of cold in my boxer area, butt, or lower back. ( also in my shins and occasionally even my arms) [nor this] On 4/30/2022, I had been in discomfort for almost two months. I scratched an itch, noticed it hurt, and then checked - I did have an open ulcer down there. Took myself to the ER to get swabbed, came back negative. 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I was taking the Arganine to see if I could induce an outbreak. [This is irrelevant, there is no known linkage between herpes outbreaks and arginine/lysine intake - its a myth - and B12 infers nothing.] I think what I am asking is - has anyone here ever repeatedly tested negative over and over again over long period of time, before getting a definitive answer, be a positive test, or something else? [The answer to this is: Extremely few people with a HSV-1 infection and even more rarely HSV-2 test repeatedly negative on Westernblot and actually carry the virus. 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There are hundreds if not more than a thousand experiences on this website alone that are similar to yours that are truly negative for herpes I'm one of them!]  
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