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I agree with that 100%! Good post.
Music to our ears!!! Great post Green!
Bingo! Bring on the news, and sales figures from cobroxin, as well as if we are lucky enough to see a show on The Doctors, will definately give us a boost! Go NPHC!!
I would think anyone who has followed this stock knows its a bargain at these prices. Who cares if we have to hold a year, it will be well worth it down the road. Multikine is the key, and everything else is gravy. I will be surprised if this closes below 1.00! Too much potential, and news is looming out there, the smart ones will buy more and get rewarded with that news. All is MY OPINION only, but Im not selling before $10.00! Although they could be bought out before that, and im sure if they are, we will be just as happy!
Multikine® Phase III Clinical Trial Design
Study Summary: A Pivotal Phase III, Open-label, Randomized, Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity Versus Standard of Care Only.
Objectives: The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to Standard of Care (SOC) as measured by overall survival. The secondary objectives are to evaluate the effects of Multikine® treatment on the cumulative incidence of local-regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, while confirming Multikine® safety.
Number of Subjects: Approximately 800
Clinical Centers: 40 - 50 (globally distributed; North and South America, Europe, Asia)
Enough with the negativity already. Always doom and gloom with you. This is an opportunity to pick up more shares on the cheap. If you believe in the stock, then buy some more. If not, sell and buy something else. Their technology is sound, and will pay off, if not right away, soon enough. But the doom and gloom just breeds more negativity and scares people into selling.
Will be waiting for the news that will send this up where it belongs. IMO, this is worth more than its current pps if what the users of cobroxin are saying is true. Cant wait for mine to get here! Nyloxin can also be a great catalyst to take us to the next level. Cant wait for that too!
I hope all longs have gone to the Doctors website, voted to have Cobroxin featured on a show, and left a testimonial. If not, heres the link:
http://www.thedoctorstv.com/produce/home
Lets take this National!!
no reason for this to have dropped. Good news out on the muscular dystrophy front and its been slowly going south. No reason for this drop.
Wondering the same thing. Had pos news on the muscular dystrophy, and went down, and has continued to. I think the whole sector is getting dumped on, IMO!
It looks like this sector is not getting any love the past week or 2. CVM, ADXS, EPCT, NHPC, to name a few, have all had positive news in one form or another, and all have gone down. Figures, the bashers swoop in and scare the weak hands into selling and costing good honest investors their hard earned money. The sec really needs to take a stand against these practices, IMO!
Interview with Rik J Deitsch: Interesting read!
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published – October 23, 2009
CEOCFO: Mr. Deitsch, you have been CEO for Nutra Pharma a number of years; what was your vision for the company and has that changed?
Mr. Deitsch: Our vision has remained the same since I took over Nutra Pharma. We continue to seek interesting property, what I call diamonds in the rough. There are some amazing biotech companies, medical device companies, and individuals in the field. There are many companies that are either under-capitalized and/or poorly managed. If they had decent management and access to capital there is no telling what they could accomplish. Over the years, we have acquired these properties. We have acquired medical device technology and put it into our Designer Diagnostics subsidiary and acquired drug discovery technology and put it towards ReceptoPharm. Over the years, we fleshed out that business plan to the point where we now have marketable products and devices and drugs.
CEOCFO: Is there a common thread among your past acquisitions and future target acquisitions?
Mr. Deitsch: In the past, we have always looked at untapped marketplaces, especially disease states that were unmet by the current medical devices or drug therapies. For example, one of our primary drug indications is Adrenomyeloneuropathy (AMN), which is a fatal orphan disease with 30,000 patients globally and no treatment options. Big pharma is just not paying any attention to it and we had an opportunity to change lives by helping these people through our drug platform. Similar to Multiple Sclerosis (MS), it is a demyelinating disorder. Working with AMN patients provides a great rationale to other demyelinating disorders, such as Multiple Sclerosis (MS) and Adrenoleukodystrophy (ALD). Our work with AMN allows us to grow the company and, at the same time, help people. Our goal is to build Nutra Pharma to be fiscally responsible, but also help as many people as possible while we are doing it.
CEOCFO: What is a demyelinating disorder?
Mr. Deitsch: A demyelinating disorder is the condition where the myelin sheath, the insulation around your nerves, deteriorates. There is a variety of different disorders like that. Imagine that your nerves are like electrical wires. If you strip the insulation off an electrical wire, it will not carry a charge. Similarly, the myelin is the fatty sheath around a nerve that insulates the nerve. When that fatty sheath is gone, your nerves will not function.
CEOCFO: Has your business plan changed over the years?
Mr. Deitsch: Our business plan has changed. At first, we would license and buy small parts of companies, but we have evolved to the point where we have acquired a wholly owned drug discovery subsidiary, ReceptoPharm, and have acquired the technology in our medical device subsidiary, Designer Diagnostics. Any further acquisitions we are going to make will be a whole acquisition of the company and its technology.
CEOCFO: Would you tell us about Cobroxin?
Mr. Deitsch: Cobroxin is for the treatment of moderate to severe chronic pain. We have been studying pain for several years, but it was not our primary application. It was simply an indication we were working on as part of our background technology for our drug platform. More recently, we published a study that we were conducting at Soochow University in China that showed that our pain drug outperforms morphine in an animal model. In fact, it lasted four times longer than morphine and was more than twice as effective. If you match it against morphine molecularly, there is so little Cobra venom peptides needed that Cobroxin was actually 600 times more potent than morphine. That really was a revelation for us and told us we needed to move in this direction. Additionally, because the amount of peptides utilized are so few, it qualifies as a homeopathic drug in the United States, under the United States Homeopathic Pharmacopoeia. This allowed us to bring it directly to market as an over-the-counter pain drug.
CEOCFO: If Cobroxin can accomplish the same pain relieving effects of morphine, but without the side-effects, that is huge!
Mr. Deitsch: It is absolutely huge! But understand this it is not a new idea, as Cobra venom has been used for literally thousands of years in China as a therapeutic agent for a variety of different purposes with a variety of different extracts. We have been studying different proteins from various animals including the Cobra for the last ten years. Additionally, Cobra venom had been used as a painkiller even by the United States government. It was used by soldiers during World War II, but when cortisone became popular and then other pain killers became accessible, people just stopped using Cobra venom. I think the biggest reason it stopped being used in the 1940s and 1950s was that it lacked standardization. We didn’t have the tools back then to measure the amount of peptides, the type of peptides that were in it and contamination, such as bacterial and fungal contamination. We also did not have the tools to properly clean, sterilize and standardize the solution, so you wound up with bad batches and ineffective batches. Now, with the technology we have today, we can tell you exactly what is in every batch and verify that it is sterile, clean and is going to be effective. We are really bringing back an old technology with a new delivery system that will make the product successful in the marketplace.
CEOCFO: What are your plans for marketing and distributing Cobroxin?
Mr. Deitsch: We have outsourced this to a company called XenaCare Holdings, which will do all of the marketing and distribution in the United States. They start their marketing campaign in November (2009) and our Cobroxin product will be on store shelves as an over-the-counter treatment for Stage 2 pain, which is chronic persistent pain. When I say Stage 2 that is a little hard for people to understand. Stage 2 pain is pain that interferes with either sleep and/or work. For the most part people are taking a prescription of Vicodin, Percocet, or Oxycodone. Cobroxin gives them a new choice for an over-the-counter product that is non-narcotic, non-addictive, non-opioid, and is relatively inexpensive compared to many of the other alternatives. We will roll out in the United States with XenaCare, but we are continuing to seek distributors in other countries. We expect a full national rollout by January through television commercials and advertising and then we are looking at expanding to Canada, Australia, Europe, and South America throughout 2010.
CEOCFO: How do we know there are no side-effects?
Mr. Deitsch: There were 46 published studies on the use of cobra venom and this particular dilution of cobra venom since the early 1900s. All those studies are available on the drug’s website, www.Cobroxin.com so people can see the clinical safety profile. Additionally, as a homeopathic dilution, it is considered safe and non-interactive. Because the active components are peptides, they are not toxic to the liver. They get absorbed very easily, so there are no issues with GI distress unlike the NSAIDS: aspirin, ibuprofen and naproxen. It eliminates the GI issues, the liver issues you get from Tylenol based products and acetaminophen products and it eliminates all the narcotic effects from opiates. Conservative estimates in the clinical studies suggest that it will be at least 80% effective, but there will be some people that will be resistant to it, so there are still going to be some people that are going to need to use these other products.
CEOCFO: What else is in the pipeline?
Mr. Deitsch: This is where I really want to make sure people understand that Nutra Pharma is a platform company. We have technologies that will allow us to launch a variety of different drugs for different indications over the next ten years. Our primary indication after pain is Multiple Sclerosis. We have been studying Multiple Sclerosis for more than ten years and have an incredible drug that has shown in open-label clinical studies to reverse the symptoms of Multiple Sclerosis. There is currently no drug available on the market for the treatment of Multiple Sclerosis that reverses those symptoms. All of the drugs for MS only slow the forward progression of the disease and have many side effects. Our drug has been through Phase I trials and has shown in early open-label clinical studies to not only have a very limited amount of side-effects, but, in many patients, reverse the symptoms where people can start to live normal lives as long as they stay on the drug. It is our goal over the next twelve to eighteen months to initiate Phase II clinical studies in Multiple Sclerosis and then seek a licensing partner for the Phase III study or to begin a Phase III study and to market the drug ourselves.
CEOCFO: What are you doing with your medical device division, Designer Diagnostics?
Mr. Deitsch: In Designer Diagnostics, we have eleven patents for test kits for the rapid identification of mycobacteria, which are a specific type of bacteria that is very hard to culture and very hard to grow. In fact, there was an article recently about people getting mycobacterial infections through showerheads, especially women that take long hot showers and breathe in steam. These infections are terrible because they can be fatal. The worst part is they are very hard to diagnose. The bacteria grow so slowly that a normal test for something like Paratuberculosis can take 10 to 12 weeks. With our test kits, it takes less than 10 days. Therefore, we greatly cut down the amount of time it takes to test for some of these infectious agents. In addition, Mycobacterium avium complex (MAC) is one of the leading causes of death among AIDS patients. It causes AIDS wasting syndrome and by the time it is discovered in an AIDS patient, it is far too late to treat the patient and it becomes a fatal condition. With our test kits, you can test an AIDS patient on a monthly basis and, in less than 10 days, have an answer. If the patient has Mycobacterium avium complex, you can treat that before it becomes an issue.
CEOCFO: What is the financial picture of Nutra Pharma today?
Mr. Deitsch: For the last three years, we have been financing the company internally and through small private placements. It always looked like we had no money because we never wanted to raise more than we needed, especially when our share price was so low. Now we are in a great situation because we are no longer pre-revenue; we have a revenue stream. Even before Cobroxin, we started utilizing our lab space and clean room to do clinical research (CRO) services for other companies and that brought in a few hundred thousand dollars through Clinical Filling and CRO services. Additionally, we now have Cobroxin and rough estimates are, even at a minimum, several hundred thousand dollars a month in sales. This should certainly cover our burn rate and our future clinical trial expenses. If Cobroxin does what we expect it could do and capture a percentage of the market, it could certainly fund us without any need for capital raises in the future.
CEOCFO: A very exciting time!
Mr. Deitsch: It is a great time for Nutra Pharma and I just hope everyone keeps watching us and see how we do.
CEOCFO: Is the investment community starting to pay attention?
Mr. Deitsch: It is, but we are still considered a penny stock even though we have gone from $0.02 a share to $0.55 a share over the last seven months. As such, many analysts won’t touch us and many people won’t watch us as a company. However, what is so funny is that as we generate revenues and this company grows and becomes even $4 or $5 a share in the years ahead, suddenly all these analysts will discover us and think that ‘oh what an overnight success.’ They do not realize it might have been a much better investment at $0.02.
CEOCFO: Why should potential investors choose Nutra Pharma out of the crowd?
Mr. Deitsch: I would say that of all the sectors out there, biotech is the sexiest sector. With drug discovery, with the aging population, with the understanding of diseases that we never knew before, biotech is really a draw for well-informed investors. When you look at biotech, the biggest problem is the burn rate and the fact that 99% of biotech companies are pre-revenue, as they are R&D level companies. Here we have a company that is already in revenues, paying their bills, and that is going to stop, cease or greatly reduce the possibility of dilution now and in the future. When you consider that, we stand head and shoulders above any other small biotech companies in our field.
CEOCFO: What would you like to say in closing?
Mr. Deitsch: If people want more information about Nutra Pharma, I invite you to visit our corporate website at www.nutrapharma.com. For more information on Cobroxin, we have detailed product information available at www.cobroxin.com. Finally, in addition to Cobroxin, we will be launching a prescription drug called Nyloxin in late-2009. This prescription medicine will be for people with severe Stage 3 pain. We will continue to release information about Nyloxin over the coming weeks.
disclaimers
Any reproduction or further distribution of this article without the express written consent of CEOCFOinterviews.com is prohibited.
In the past, we have always looked at untapped marketplaces, especially disease states that were unmet by the current medical devices or drug therapies. For example, one of our primary drug indications is Adrenomyeloneuropathy (AMN), which is a fatal orphan disease with 30,000 patients globally and no treatment options. Big pharma is just not paying any attention to it and we had an opportunity to change lives by helping these people through our drug platform. Similar to Multiple Sclerosis (MS), it is a demyelinating disorder. Working with AMN patients provides a great rationale to other demyelinating disorders, such as Multiple Sclerosis (MS) and Adrenoleukodystrophy (ALD). Our work with AMN allows us to grow the company and, at the same time, help people. Our goal is to build Nutra Pharma to be fiscally responsible, but also help as many people as possible while we are doing it. - Rik J Deitsch
This was great encouraging news on an upcoming possible cure of Muscular Dystrophy and the stock is down. IMO, this is a stock waiting to explode, and I dont think too many people realize it. Will keep adding on these dips, and 1 day retire on this one!
This should have sent the stock upward, dont understand:
New Data Supports Pharmacoeconomic Benefits of Ceplene®
Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene® (histamine dihydrochloride) for the remission maintenance of Acute Myeloid Leukemia (AML) patients in first remission. These data are being presented in two separate poster presentations on October 25 and 27, 2009 in Paris, France at the Twelfth Annual European Congress of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).
Researchers from Applied Healthcare Resource Management Inc. engaged by EpiCept analyzed data from the pivotal Phase III clinical trial for Ceplene® to determine the incremental cost effectiveness of Ceplene® with low-dose interleukin-2 (IL-2) versus current standard of care for remission maintenance of AML patients in first complete remission. The focus of the researchers was on the economic impact on the healthcare system in the United Kingdom. The United Kingdom represents approximately 13% of the population of the European Union.
According to the researchers, the expected cost to the U.K. healthcare system to administer Ceplene® to all eligible AML patients is approximately £24.1 million per year. The estimated annual savings due to decreased relapse events ranges from £2.5 to £3.5 million. As such, the study concluded that the budget impact to adopt the use of Ceplene® plus low-dose IL-2 for AML is well within the established per-patient reimbursement threshold for a new drug. The analysis assumes that all eligible patients are treated; if fewer patients are treated, then the net budget impact would be less.
The pharmacoeconomic benefit of Ceplene® may have been underestimated in this model, as a monetary value was not assigned to the quality of life improvement that is associated with fewer relapses.
“As the only therapy approved in Europe to maintain first remission in AML patients, we believe Ceplene® can play a unique role in addressing this deadly disease,” remarked Jack Talley, President and CEO of EpiCept. “We commissioned this study to further validate the commercial potential of Ceplene® to prospective partners, and guide the pricing and reimbursement rationale for this innovative medicine.”
About Ceplene®
Ceplene® is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission. EpiCept is continuing negotiations with several prospective partners for the European marketing rights to Ceplene®. In June 2009 EpiCept launched a named patient program for Ceplene® in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene®.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene®, which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept™ NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
im right there with ya Tone. Should have dumped it and didnt, hoped it would base and didnt, now back to even. Maybe buy some more now! Still think its a good play though!
Make sure you go the doctors website and vote to have them do a show on the product. You can also leave comments there, so tell them your story. At last look, we took over the number 1 spot under alternative medicine/most popular. Heres the link if you need it:
http://www.thedoctorstv.com/produce/home
News out:
New Data Supports Pharmacoeconomic Benefits of Ceplene(R)
TARRYTOWN, N.Y., Oct 26, 2009 (BUSINESS WIRE) -- Regulatory News:
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene(R) (histamine dihydrochloride) for the remission maintenance of Acute Myeloid Leukemia (AML) patients in first remission. These data are being presented in two separate poster presentations on October 25 and 27, 2009 in Paris, France at the Twelfth Annual European Congress of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR).
Researchers from Applied Healthcare Resource Management Inc. engaged by EpiCept analyzed data from the pivotal Phase III clinical trial for Ceplene(R) to determine the incremental cost effectiveness of Ceplene(R) with low-dose interleukin-2 (IL-2) versus current standard of care for remission maintenance of AML patients in first complete remission. The focus of the researchers was on the economic impact on the healthcare system in the United Kingdom. The United Kingdom represents approximately 13% of the population of the European Union.
According to the researchers, the expected cost to the U.K. healthcare system to administer Ceplene(R) to all eligible AML patients is approximately £24.1 million per year. The estimated annual savings due to decreased relapse events ranges from £2.5 to £3.5 million. As such, the study concluded that the budget impact to adopt the use of Ceplene(R) plus low-dose IL-2 for AML is well within the established per-patient reimbursement threshold for a new drug. The analysis assumes that all eligible patients are treated; if fewer patients are treated, then the net budget impact would be less.
The pharmacoeconomic benefit of Ceplene(R) may have been underestimated in this model, as a monetary value was not assigned to the quality of life improvement that is associated with fewer relapses.
"As the only therapy approved in Europe to maintain first remission in AML patients, we believe Ceplene(R) can play a unique role in addressing this deadly disease," remarked Jack Talley, President and CEO of EpiCept. "We commissioned this study to further validate the commercial potential of Ceplene(R) to prospective partners, and guide the pricing and reimbursement rationale for this innovative medicine."
About Ceplene(R)
Ceplene(R) is approved in the European Union for the remission maintenance and prevention of relapse in patients with AML in first remission. EpiCept is continuing negotiations with several prospective partners for the European marketing rights to Ceplene(R). In June 2009 EpiCept launched a named patient program for Ceplene(R) in partnership with IDIS under which physicians in all major global markets excluding the U.S. can prescribe Ceplene(R).
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene(R), which has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. The Company has two oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept(TM) NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Looking good! We have taken over the number 1 spot under alternative medicine/most popular. Keep it going, and we should see a show on the company and product. Every household should keep some of this on hand. Go to the following link and vote for cobroxin and also make sure you leave a comment on the product and how it is helping you or someone you know!
Lets make this product a household name!
http://www.thedoctorstv.com/produce/home
Trying to get a show about Cobroxin on the doctors, which aires weekdays in the afternoon. If you follow the link here, you can sign up, give a testimonial and vote to have them do a show about the company and product. Looks like we are getting some backing already there. Go to the alternative medicine category, and then click most popular. We are the second most popular right now. Lets bombard the site and get them to do a national show!! This is one of the most watched shows nationally, and backed by doctor phil.
http://www.thedoctorstv.com/produce/home
Anyone follow EPCT?
Over 3 times normal daily volume today. Would appreciate any info anyone has on the company. Thanks
Isnt that article an old one? Things have changed since then. You really didnt answer my question and i would appreciate it if anyone could respond! Thanks in advance.
Wouldn't it mean if they have the marketing and distribution rights, thats just what they have, nothing more. It doesn't say they have the licensing agreement, or rights to the actual product and the profits from it, just the marketing and distribution rights. NPHC will still get the profits, while paying XenaCare to market and distribute it. Whether they pay them with stock or cash, the bulk of profits go to NPHC. Am I right in that assumption?
Deep, very deep!! But I like it!! Nice post, and nicely put!
Nothing wrong with that. Thats how I found out about ICLK at 1.70. That was 3 weeks or so ago. Doing well with it! Now at 2.65!
Wish I had more cash available, I'd gladly buy yours!! IMO, I dont think bailing now is smart, and definately dont think it gets to .75 again, unless everything they are doing falls apart. Too much goin for them, all we need is just a little patience! IMO
We are about double the average dailly volume, not quite but close, and wonder if something is about to happen. Its long overdue! Any thoughts, this board has been really quiet? Volume preceeds price!
Looking around a little, I came across this. Probably old news to some, but I think it shows the faith in this stock. Lots of big boys bought btw June and october, and hopefully that means they expect good things in the near term, and not just because they were added to the Russell.
http://www.quote.com/us/stocks/topholders.action?s=AVII
good idea. I will contact my friends at the local stations as well. I graduaTED from broadcasting school in january.
He actually said over 500 orders, which could mean multiple pcs per order, so well over that 10k figure!!
The why not order some cobroxin!!!lmao
cant figure it out. Ive been in and out of this since .90 cents, and every time u think its gonna blow, it deflates back down. They have great potential, but i think we need some news on their trial results to give it a swift kick and send it up! Dont give up the short term agravation for long term profits, imo!
tx for the info
thanks for the info!!
Have not followed spng since before it announced a reverse split. What in the world has happened? Did this turn out to be a scam or what? So I dont have to read all the previous posts, can someone please give me a brief explanation as to what happened. I sold my shares and was waiting to buy in after the reverse split and was high on their potential, but now i see this and red flags all over. Thankyou.
Leave it to Adam Foreskin, he just wont give up!
sorry, i found the info i posted on the conference site yesterday, so i thought it was new. How they had some similar info on friday is beyond me, but maybe the leak was what caused that late day spike. All i know, im glad to be a shareholder in this one so early. Not selling this baby until 30.00, or a big buyout, whichever comes first!! Long and strong!
excellent comeback after the release. Anyone with half a brain can see the huge potential in this stock! IMHO
Sorry cant reply privately, but they had the release at 9:45 this morning. Check my submission for the release!
That is my feeling as well. The skys the limit with their technology. If you have the patience to stick with them, I think we will be greatly rewarded down the road. Just my personal opinion, but I really think this can be a grand slam!
heres this mornings release: yea baby!!!
CEL-SCI Presents Data at American College of Rheumatology Conference Which Suggests that CEL-2000 Has Potential to Slow Damage Caused by Rheumatoid ArthritisOctober 19, 2009 9:45 AM ET advertisement
Article tools E-mail this article Print-friendly version Discuss this articleStocks mentioned in this articleCEL-SCI Corp (CVM) Stock Quote, Chart, News, Add to WatchlistRecent investing newsHealthWell Foundation(R) Appoints New Executive DirectorMarket Report -- Short Stories (ANF)Market Report -- Short Stories (FHN)Icahn Today Stated That CIT's Planned Reorganization, With All Its Attendant Fees and Its Method of Vote-Buying, Is the Quintessential Example of What Is Wrong With Our Bankruptcy Process in AmericaMarket Report -- Short Stories (FNM)
All PR Newswire news
Statistically Significant Results Support Approach Of Company's H1N1 Platform
VIENNA, Va., Oct. 19 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE Amex: CVM) announced today the presentation of new rheumatoid arthritis data at the American College of Rheumatology's annual meeting in Philadelphia, PA. The data, presented by Dr. Daniel Zimmerman in conjunction with the Company's collaborators from Washington Biotech, Northeastern Ohio Universities College of Medicine and BolderBiopath, indicate that CEL-SCI's rheumatoid arthritis treatment vaccine CEL-2000 acts to prevent or retard the permanent tissue damage caused by rheumatoid arthritis in animals. These statistically significant results were demonstrated by the measurement of four different parameters, suggesting that CEL-2000 appears to block the immune response that causes the autoimmunity which leads to rheumatoid arthritis. The long term results obtained with fewer doses of CEL-2000 vaccine were comparable or better than those seen with Enbrel�, a leading treatment for people with rheumatoid arthritis.
Geert Kersten, Chief Executive Officer of CEL-SCI said, "These results were achieved through a reduction of the inflammatory response that attacks the patient's joints. The goal for our new H1N1 therapy for H1N1 hospitalized patients is not dissimilar. Many of these patients die from the excessive inflammatory response. We feel that this new data is encouraging both for this rheumatoid arthritis vaccine as well as supportive of our H1N1 treatment."
In these studies, mice were injected with collagen to induce the autoimmune disease. Therapy with Enbrel or CEL-2000 was initiated and continued for 28 days after the initiation of a significant, uniform, and measurable level of arthritic disease in groups of mice. CEL-2000 was administered only twice, but Enbrel was administered every other day for the first 28 days. The extent of disease, as indicated by deformation of foot joints (Arthritic Index (AI) score), of untreated, and CEL-2000 and Enbrel treated groups, was compared. In another study CEL-2000 was administered 5 times over a 70 day period and the animals were monitored for another 20 days for a total study period of 90 days. In each case, CEL-2000 treatment proved effective at blocking the progression of disease with statistically significant reduction in AI score compared to the appropriate controls and was safe and well tolerated without any adverse effects. The protection mediated by CEL-2000 treatment was also demonstrated histologically by significant reductions in 1) inflammation, 2) cartilage destruction 3) bone resorption, and 4) pannus membrane formation in the synovial space compared to untreated controls.
The CEL-2000 treatment appeared to change the course of the immune response in the diseased and treated animals by limiting the development of a destructive Th17 and tumor necrosis factor alpha (TNF-alpha) directed autoimmune response. Analysis of serum levels of 21 cytokines/chemokines indicated reductions in the characteristic cytokine markers of rheumatoid arthritis, TNF-alpha and IL-17, and also IL-6, and MCP-1. A number of cytokine changes were also seen with Enbrel treatment, but to a lesser degree.
CEL-2000 may also offer a number of potential advantages over existing rheumatoid arthritis treatments, such as Enbrel. Data collected in the animal studies conducted with CEL-2000 demonstrated that CEL-2000 is an effective treatment against arthritis even with the administration of fewer treatments. CEL-2000 is also potentially a more disease-type specific therapy, should be significantly less expensive and finally, CEL-2000 could also be useful for patients who are not able to take or who may be unresponsive to existing anti-arthritis therapies.
Rheumatoid arthritis treatments comprise a $13 billion market. Enbrel, a leading rheumatoid arthritis treatment sold by Amgen and Wyeth, reported US sales in 2007 of about $3.2 billion. Enbrel is a soluble recombinant protein of a human TNF-alpha receptor linked to human IgG Fc. In some cases, human or humanized monoclonal antibodies specific against TNF-alpha have also been used for therapy in rheumatoid arthritis. These therapies remove or inactivate TNF-alpha, a natural human cytokine required in many immune functions for normal defenses.
CEL-SCI's rheumatoid arthritis vaccine CEL-2000 was discovered as part of work with the Company's ongoing research and development activities with its L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System) technology. L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize proprietary immunogens. Any disease for which an antigenic sequence has been identified, such as infectious, parasitic, malignant or autoimmune diseases and allergies, are potential therapeutic or preventive sites for the application of L.E.A.P.S. technology.
The concept behind the L.E.A.P.S. technology is to directly mimic cell-cell interactions and activate immune cells with synthetic peptides. The L.E.A.P.S. constructs containing the antigenic disease epitope linked to a immune-cell binding ligand (ICBL) can be manufactured by peptide synthesis or by covalently linking the two peptides. Depending upon the type of L.E.A.P.S. construct and ICBL used, CEL-SCI is able to direct the outcome of the immune response towards the development of T-cell function with primarily effector T-cell functions (T Lymphocyte; helper/effector T lymphocyte, type 1 or 2 [Th1 or Th2], cytotoxic [Tc] or suppressor [Ts]). Therefore, it would appear that the L.E.A.P.S. construct represents a chimeric peptide with bi-functional behavior.
Additional details on the presentation are available at http://acr.confex.com/acr/2009/webprogram/Paper10996.html.
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine� which is being readied for a global Phase III trial in advanced primary head and neck cancer. CEL-SCI is also developing a treatment for hospitalized H1N1 patients using its L.E.A.P.S. technology platform and expects to soon finish the validation of its state-of-the-art facility in Maryland.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, lack of regulatory clearance to proceed with clinical trials, an inability to duplicate the clinical results demonstrated in clinical studies that have been completed or that are initiated in the future, timely development of any potential products that can be shown to be safe and effective, unwillingness of regulatory authorities to engage in further regulatory dialogue, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K/A for the year ended September 30, 2008. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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