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Chimerix has started enrolling! But where???


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http://www.clinicaltrials.gov/ct2/show/NCT01143181?term=Chimerix&rank=1

Locations

United States, California

CHOC Children's

Orange, California, United States, 92868

Contact: Cathy Flores 714-516-4339 maflores@choc.org

Principal Investigator: Delma Nieves, MD

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Contact: Jennifer Theusch, MT (ASCP), MBS, CCRC 773-702-1665 jtheusch@medicine.bsd.uchicago.edu

Principal Investigator: Kathleen Mullane, DO

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198-5130

Contact: Karen Semisch 402-559-8930 ksemisch@unmc.edu

Principal Investigator: Diana Florescu, MD

United States, New York

Memorial Sloan Kettering Cancer Institute

New York, New York, United States, 10065

Contact: Dick Chung 212-639-3158 chungd@mskcc.org

Principal Investigator: Genovefa Papanicolaou, MD

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Contact: Maggie Peterson 919-668-1280 maggie.peterson@duke.edu

Principal Investigator: Joanne Kurtzberg

United States, Utah

Intermountain BMT program LDS Hospital

Salt Lake City, Utah, United States, 84143

Contact: Lisa Gamble 801-408-1455 Lisa.Gamble@imail.org

Principal Investigator: Daanish Hoda, MD

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This is for emergency purposes and would only be used if someone contracted encephalitis from HSV or other life threatening conditions. There was already an ongoing trial for this but could be expanding. This is a good thing if it proves that CMX001 can be taken safely. It is the pill form of cidofovir which is a wide spectrum antiviral that has to be diluted or it could cause kidney damage. Chimerix had made it into a pill form that is hopefully much safer since it is not metabolized by the kidneys. Cidofovir is the last resort for resistant strains of HSV. I sure hope that it is proven safe and effective. Then, yes it could be considered a superior drug to Valtrex. I don’t know if it will rid the body of HSV but it could rid the body of other Herpes viruses. I think this one is the most promising drug yet as long as it is safe. The FDA will scrutinize the heck out of it though. So far, it has saved lives for other life threatning illnesses, including a soldier who got the small pox virus from the vaccine. We will have to see how it plays out but I doubt that anyone with even chronic ob’s will get this unless it’s really really bad.

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This is for emergency purposes and would only be used if someone contracted encephalitis from HSV or other life threatening conditions. There was already an ongoing trial for this but could be expanding. This is a good thing if it proves that CMX001 can be taken safely. It is the pill form of cidofovir which is a wide spectrum antiviral that has to be diluted or it could cause kidney damage. Chimerix had made it into a pill form that is hopefully much safer since it is not metabolized by the kidneys. Cidofovir is the last resort for resistant strains of HSV. I sure hope that it is proven safe and effective. Then, yes it could be considered a superior drug to Valtrex. I don’t know if it will rid the body of HSV but it could rid the body of other Herpes viruses. I think this one is the most promising drug yet as long as it is safe. The FDA will scrutinize the heck out of it though. So far, it has saved lives for other life threatning illnesses, including a soldier who got the small pox virus from the vaccine. We will have to see how it plays out but I doubt that anyone with even chronic ob’s will get this unless it’s really really bad.

Actually this is an open expanded access trial so anyone that has herpes is able to participate. This is not the emergency use program. That is separate.

CMX001 is highly effective and it is many fold more effective than acyclovir. There are many research docs online so do some searches. This is the best thing we are going to have for many years to come.

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Struggle, your getting me all excited. CMX001 should be very effective. It may even clear it, but not so sure about that. I still do not think that most people will qualify but sent them an email asking if a person has been determined to have a resistant strain or all other treatments have failed, would they be allowed to participate. Open access also means that it is possible that you can get your physician to get the drug from Chimerix for you if you don’t live near a clinical trial site. I don’t know if my physician would be willing or not, but if they say I qualify based on what I told them, I’m sure going to give it a shot. I am really hoping this drug is as safe as Valtrex. I have been on a gram of Vatrex for two weeks and now on ob #2. This is a wide spectrum antiviral and can help millions of people. It could be to most viruses what antibiotics are to bacteria. I have done the research and this is good stuff. I sure hope it is proven safe. This drug has already saved lives. I sure hope I get a shot at it.

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Sweet7 - I am glad I can get you all excited :p

I'm not sure about "clearing it" but I think it's going to revolutionize conventional anti-v treatment (I hope). This trial is open to those who have not proven responsive to the acyclovir family of medicines (my words). Have your doc contact them and make sure all your tests are in your medical notes. You don't need to by dying from it, just that you've run out of options (and that it's extremely problematic, I assume). I think Chimerix is very interested in proving it's efficacy in treating HSV. They would make a lot of money displacing Valtrex. CMX001 is their big drug.

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How effective is it?

As an example, I think I read how it 100% cleared HSV from infected animal brains. Yes, completely cleared with no recurrence. Acyclovir only removed approx. 70%, and therefore did not clear the infection.

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That is accurate Struggle. Oh and thank for pointing this out to me again. After taking another look, I realized you could very well be right. I have tried all available and my doc says I shouldn't be having any ob's. But I still have mild ones. She is concerned that I have a resistant strain but I think part of it is because I didn't have HSV-1 and I have sleep disorders which are neurolgical problems. There might be something wrong with my neurons that keeps the virus active. Anyhow, I'm going to wait for a response back from the trial coordinator for a few days. If I don't hear back, I'll get with my doc and talk to her about it. I just wanted to try the gram of Valtrex/day for a while to see if that would work. I don't think it's working and I really would like to help with getting CMX001 on the market. Did you know that HHV6 is suspected in 70% of the cases of MS? CMX001 just might be the miracle drug for those people. I am sure getting high hopes here.

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This would be amazing if it would work on viruses like antibiotics works on bacteria! I'm also glad that they are targeting HSV but it seems like they are only testing it for those with life threatening infections so who knows what that would eventually mean for us. Sweet 7- good luck trying to get on the trial and keep us posted. We HAVE to keep the faith and pray that we will have an incredible breakthrough soon!

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This would be amazing if it would work on viruses like antibiotics works on bacteria! I'm also glad that they are targeting HSV but it seems like they are only testing it for those with life threatening infections so who knows what that would eventually mean for us. Sweet 7- good luck trying to get on the trial and keep us posted. We HAVE to keep the faith and pray that we will have an incredible breakthrough soon!

Please don't be misguided by the life threatening criteria. This is expanded access so it does not require life threatening conditions.

If you have HSV, have frequent OB's and have NOT responded to conventional treatment then you may be accepted into the program.

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So what does this mean for us struggle83? Is this going to be on the market soon or? Seems like you know quite a bit about it. Thanks for any information that either I a) read and missed or B) read and forgot.

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There is more information about chimerix here but from what i understood this drug would be definitely the drug to have. They are currently working with the FDA so im sure if this is a success it won't be too hard to get on the market.

more info here http://www.chimerix-inc.com/news-and-resources/news-and-resources-details/chimerix-commences-cmx001-open-label-clinical-study/

I took this paragraph from there and i quote

"Under the expanded-access protocol developed in conjunction with the U.S. Food and Drug Administration (FDA), patients will receive treatment with CMX001 for any of 12 different dsDNA viral infections, including adenovirus (AdV), herpes viruses (cytomegalovirus (CMV), herpes simplex virus (HSV) and Epstein Barr virus), polyoma viruses (BK virus and JC virus), and pox viruses. The CMX001-350 study will enroll 200 patients at major medical centers primarily in the United States.

CMX001 is being developed by Chimerix for dual-use as a broad-spectrum antiviral for the treatment of life-threatening viral infections in immunocompromised patients and as a medical countermeasure in the event of a smallpox outbreak."

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I know for a fact that there is no similar drug like this already approved by the FDA. The base antiviral is approved, but only through infusion because it has to be diluted or it will cause kidney damage. Chimerix has now packaged it in a pill form that allows the drug to work in a different way and not hurt the kidneys (or that's what they need to prove). This drug has already saved lives and I hope that it turns out to be just as safe as any antibiotic out there. It is a very broad range antiviral.

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Jesus sound to good to be true! There must be some one on the forum who lives nerby to be able to take part in the trial?

Is there any one who can contact the company in the USA? Tell them about us in this forum and alla the pople behind this ore mayby get more detail planing information and the info from FDA contact?

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I’m trying to figure out the answer to that question. So far I know it stops replication at the template level. It keep the virus from making a copy. I’m thinking this takes place in the neuron, but not sure about that. I do know that it is a few steps ahead of Isentress and it is 250 fold more effective than codifovir infusion. According to Dr. Bloom, if you stop replication in the neuron, the virus will die out. If he is right, this could be the drug weve been waiting for. I sure hope it is because it could hit the market before AIC316 because it has already been shown to be superior to any other antiviral for HSV. This might be something to take for a few weeks to months. This trial is only for about 200 people so I doubt I have a shot. None the less, if all goes well, it could be fast tracked and hit the market quick. Help get those petitions signed folks. I think were being heard.

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ummm i put the link there so people could read about it but in response to your question they are still trying to find a dose, here is a detailed explanation.

"Chimerix is currently conducting a Phase 2 dose-defining clinical study of CMX001 in immunocompromised hematopoietic stem cell transplant patients at risk of life-threatening infection with CMV, which has enrolled over 130 patients. Additionally, the Company is initiating a Phase 2 clinical study in immunocompromised pediatric and adult hematopoietic stem cell transplant patients with AdV infections.

“Data from this open-label clinical study will be a critical component of our strategy to develop CMX001 as a broad-spectrum antiviral agent,” said Kenneth I. Moch, President and CEO of Chimerix. “We anticipate that the CMX001-350 study will provide important supportive data for our overall clinical development program.”

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 dsDNA viral diseases. 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 (CMX001-305) 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.

Over 325 people have received CMX001 to date, including over 130 patients treated under Emergency INDs. CMX001 has been well tolerated in all studies, with a growing body of evidence of the compound’s antiviral activity in humans. CMX001 is also being developed as a medical countermeasure in the event of a smallpox outbreak. Chimerix has received significant funding from the National Institute of Allergy and Infectious Disease to develop CMX001 for smallpox.

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The dose may not matter if it only stops replication but doesn't clear the virus in the neurons. Well, the dose does matter at least when it comes to replication. It's driving me nuts to try to find out if the virus will simply disappear if it cannot replicate at all. Over all, if we could take this medication as suppression therapy, it would be as good as a cure.

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Any new antiviral will be expensive, however, much of the development cost was paid by the NIH. The recovery cost may be much less than some antivirals because this drug may very well get fast tracked. That means less cost in clinical trials. It may come out as a last resort type of drug for about a year. Once it can be prescribed as a first line of defense drug, the cost will come down quite a bit. Then eventually a generic will be on the market. Another thing to keep in mind is that this drug is a wide spectrum antiviral as well. That means Chimerix will make up the cost it has into it much faster than other drugs that only target one or a few conditions. It’s my hope that it is safe and can hit the market asap. I won’t mind paying more for it for a while.

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