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That's the best you can provide about an CTO, an patent!!??
How about the possibilities of a merger or buyout in the near future, majority of the times it's very good news...JMHO
Okay everyone!! Lets see what happens Monday November 13th. Could it go back to its original price per share. This is VERY INTERESTING........JMHO.
Argos Therapeutics Provides Update on Immunology Data from the Phase 3 ADAPT Trial Presented at the SITC 2017 Annual Meeting
DURHAM, N.C., Nov. 11, 2017 (GLOBE NEWSWIRE) -- Argos Therapeutics, Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today provided an update on the immunology data from the February 2017 interim analysis of data from the ongoing Phase 3 ADAPT clinical trial evaluating Rocapuldencel-T for the treatment of metastatic renal cell carcinoma (mRCC) presented in the poster session at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland. The presentation is focused primarily upon immunology data from the ADAPT clinical trial and includes both new data and an update to data that was previously presented at the European Society of Medical Oncology Conference in September 2017 that now includes additional patients.
As background, a total of 462 patients were enrolled in the ADAPT study and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib (combination arm) vs. sunitinib monotherapy (control arm).
Immunology data from the February 2017 interim analysis of the data from the ADAPT study reported at the SITC Conference were pre-specified and include correlations between survival and (i) the change from baseline in antigen-specific memory T-cells, (ii) the amount of IL-12 secreted by each patient's specific Rocapuldencel-T immunotherapy, and (iii) the percentage of regulatory T-cells at baseline, which was observed in both arms of the study. Of note, data for antigen-specific memory T-cells and regulatory T-cells were available only for patients enrolled at North American sites.
Increase from Baseline in Antigen-Specific Memory T-Cells
In subjects for whom immune response data were analyzed (n=146), the number of antigen-specific memory T-cells was found to increase only after administration of Rocapuldencel-T. In those subjects who received at least seven doses of Rocapuldencel-T (n=100), the average number of antigen-specific memory T-cells after the seventh dose was approximately double the number observed before treatment. This increase was found to be statistically significant (p<0.0001). Similar data on a smaller number of patients were presented at the European Society for Medical Oncology Conference in September 2017.
Additionally, for those subjects who received at least seven doses of Rocapuldencel-T, there was a statistically significant correlation between survival and the change in the number of antigen-specific memory T-cells from baseline (Spearman's Rho = 0.40; p<0.0001). For those 25 patients with the greatest increase in the number of antigen-specific memory T-cells from baseline, no patient deaths had been recorded as of the time of the February 2017 interim analysis.
IL-12 Secretion by Each Patient's Specific Rocapuldencel-T Immunotherapy
An analysis was conducted to evaluate the relationship between the amount of IL-12 secreted by each patient's specific immunotherapy and that patient's survival. Samples from patients treated with Rocapuldencel-T as of February 2017 (n=179) were divided into two groups: those with above the median amount of IL-12, and those with below the median amount of IL-12. Comparison of the Kaplan-Meier curves for these two groups revealed that those with higher than median levels of IL-12 demonstrated improved survival. Additionally, there was a statistically significant correlation between the level of IL-12 and survival (Spearman's Rho = 0.27; p<0.0002). There was also a statistically significant correlation between the level of IL-12 and the change from baseline in antigen-specific memory T-cells for patients who received at least seven doses of Rocapuldencel-T (n=95; Spearman's Rho = 0.43; p<0.0001).
Regulatory T-Cells
An analysis was conducted to evaluate the relationship between the percentage of regulatory T-cells at baseline and survival for patients in both arms of the trial. Samples from patients in the combination arm (n=176) were divided into two groups: those with above median percentage of regulatory T-cells at baseline, and those with below median percentage of regulatory T-cells at baseline. Comparison of the Kaplan-Meier curves for these two groups revealed that those with higher than median percentage of regulatory T-cells at baseline demonstrated improved survival. This finding was in contrast to the control arm (n=79), where a greater percentage of regulatory T-cells at baseline was associated with poorer survival. One hypothesis that could potentially explain this result is that Rocapuldencel-T may be acting to convert regulatory T-cells to effector T-cells.
Commenting on the additional immunology data, Charles Nicolette, Chief Scientific Officer of Argos Therapeutics, noted, "As we have conducted additional analyses of the immunology data from the February 2017 interim analysis, we have been pleased to see that the data are generally supportive of our hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma. While we await further data from the next planned interim data analysis that we expect to be conducted during the first half of 2018, pending agreement with the FDA on a revised protocol that we plan to submit, we are encouraged to see these positive indicators of activity."
As previously reported, the February 2017 interim analysis was conducted by the ADAPT trial's Independent Data Monitoring Committee (IDMC) after 75% of the originally targeted number of 290 events (deaths) for the analysis of the primary endpoint of overall survival had occurred. At the time of the analysis, with more than half of the patients still alive in each arm and a median follow-up time of ~20 months, the IDMC concluded that the trial was unlikely to demonstrate a statistically significant improvement in median overall survival in the combination arm and recommended that the trial be discontinued for futility. However, the ADAPT trial principal investigators and Argos considered the data too immature to observe the delayed effects typically associated with immunotherapy and decided to continue the trial pending further review and analysis of the data and discussions with the U.S. Food and Drug Administration (FDA). In making this determination, Argos considered, among other factors, the degree of maturity of the data set, the mechanism of action of Rocapuldencel-T, which involves the induction of a long-term memory immune response, and the IDMC's assessment of the safety profile of Rocapuldencel-T. This determination was subsequently further supported by the extended durability of tumor responses in the combination arm, as previously reported.
Following the IDMC's interim analysis, the Company met with the FDA to discuss the ADAPT trial and the future direction of the Rocapuldencel-T program in April 2017. The FDA agreed with the Company's decision to continue the ADAPT trial, and further agreed to review a protocol amendment to extend the trial beyond the originally targeted 290 events and a revised statistical analysis plan that the Company plans to submit.
Conference Call Information
Argos will hold a conference call to discuss the data presented at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer on Monday, November 13th at 8:30am ET. To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 9396519. Slides setting forth the data presented at the SITC 2017 Annual Meeting, and a live and archived audio webcast, will be accessible through the Investors section of the Company's website at www.argostherapeutics.com. The archived webcast will remain available on the Company's website for twelve (12) months following the call.
All I'm going to say is when designated:
Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational drug or biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.
ALSO!!, If a drug or biologic is designated as a breakthrough therapy, the FDA will expedite the development and review. With this designation, all Fast Track features convey to the medicine.
Just MHO....-:)
Hey Beambe what's bull crap?
You saying they are not going to do a reverse split this Friday? Tell me something more than what I know, I'm all EARS???? Waiting..........
Yea Right, and a Reverse Split this Friday August 26th, 2016. They bamboozled people on the insider purchases of common shares like everything is gravy, and then turn around with a 1:12 reverse split.......NUTS!!!
Then they have the audacity to say the shareholders approved a reverse split.....Wow!
Next you will here about a lawsuit for entrapment.
Rabbitcoreybeach check it out.........
Biomedical Advanced Research and Development Authority (BARDA)
https://www.medicalcountermeasures.gov/barda.aspx
JohnnyD3,
Its warming up around here.....We have some news on CFS conference!
http://www.globenewswire.com/news-release/2014/03/19/619508/10073207/en/Hemispherx-Biopharma-Inc-to-Present-Clinical-Interpretations-on-CFS-Treatment-at-the-11th-Biennial-International-Research-and-Clinical-Conference.html
Hey everyone do we have shorts covering? The L2 showing a lot red for selling and very litle green, but we're UP! Don't quite get it??? Hmmmm.....GLTA.
Something promising is coming SOON!! I can feel it!
What's going on with the trades? Look like some serious covering going on. Maybe the shorts are pulling out......I don't know but its crazy. I'm holding tight hoping HEB finally get there chance they been long awaiting for......{FDA APPROVAL}.
Stockboy sorry about that I was referring to the Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) which pertaining to the 2012 Maxim LLC transaction.
What's going on here everyone. I see Hemispherx made a deal with Maxim LLC $75,000,000 Dollars!! Common Shares - Is this good or bad?
Somebody sold 250,000 share after the bell which dropped the share price. That's a usual before or after the bell due to hardly no or any shares sales action. She'll be back popping/smoking in the morning before the bell. JMHO!
You got it brother and I will flip it when I get that BOOST I've been waiting for patiently. Again, thanks for the moral support and informative facts......Semper Fi! Go HEB!!!
Horus you got it and you were right. I'm still in there, and deeper I covered down at .35. I'm still believing SOON something getting ready to POP!!! JMHO....GLTA
Yea man come on shut down and call it a night....You got it bro...good night. Marines never sleep!!
Horus I want to thank you for all your great advise, that did not have to do....Thanks and Semper Fi!! I really want HEB to bounce pretty decent tomorrow or not. I will bounce back out and go put it all on PPHM. That's my near future big runner.....PPHM. GLTY as well and Peace.
Aww man Niagara Falls is a great and powerful place, right up above Buffalo, NY. I'm from the USA, South Carolina down by Hilton Head Island. Retired from the USMC after 24 years.
Horus you are completely right about the biotechs. The $1.85 was an example I used from the recent run-up of RNN. It ran hard on a phase Ib from .40s to 52 week high $1.85. It was rallying off nothing but phase Ib nothing solid. I was just throwing that out that as a most definitely hope. Did you see what ICPT did this week. It shot up hundred of dollars, so all I'm saying is anything can happen. I believe the flu epedemic (Virus) is going to make some moves with HEB two pipeline drugs. Just believe!!!
So you would love it to drop back down for a lower entry point for you. I believe it will do like RNN on strong news up to $1.85. Run up over one dollar and settle down back close to a dollar. I can live with that because I hate to leave it and HEB surprises everyone on a over one dollar run......JMHO. I believe they can and will do it.....GLTA.
Horus, Yes you are completey correct about HEB. I'm hoping that it does a different trend and surprise us all tomorrow with news....like I said hoping. Their past does not speak well for them at all. I'm keeping my fingers crossed.
Hey HORUS,
Reading charts is definitely a great tool to learn to make better precise decisions on your investments. Charts (Technical Anaylsis) means nothing when popping news hit. See how post market price went up after hours around 7:30 pm? Remember the conference, HEB presentation starts at 7:30 eastern time which is 4:30 pacific time. With the Flu Pandemic around the world, can see no reason this should recieve recognition and a partnership deal during or after the conference........Fingers XXX...GLTA!!!!
I think it will stay strong through tomorrow because the HEB doesn't introduce their presentation until 4:30 pm PST. Never know what will happen after the presentation for partnership?????
JMHO!!!
Hey beenzoot,
I don't post much at all but I'm 15K deep in this one and 18K on PPHM but long on both. I believe this one is a creeper......JMHO.
Semper Fi!
Fast Track according to the FDA have a very significant probability of succes in treatment behind said drug.......This could come back APPROVED sooner than we expect....JMHO GLTA.....Semper Fi!
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
* Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
* Avoiding serious side effects of an available therapy
* Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
* Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment
* Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
* More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
* More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
* Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
* Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
I believe that HEB is getting ready to form up for a decent run on the upcoming news that HEB and MERCK is talking behind closed doors. Something is going to break out soon.....JMHO!
YEEEAAAA!!! Devil Dog!!!
Semper Fi!!
Lima Charlie!!!
Did anyone else read this from the FHFA report". Seem to be very good new coming out of c-ship as a joint venture with CSP LLC?
"Fannie Mae and Freddie Mac have formally established Common Securitization Solutions, LLC as the joint venture that will own the CSP and related business and operational functions".
Good to go....at the AM tomorrow Lima Charlie. If she's green tomorrow we are going to be just fine.
Yea USMCVET, you miss those BRU-32A/A Ejector Bomb Racks. Pretty decent racks though. I BBQ a lot now...South Carolina "Mac's Pork N' Us" ~Tender Butts and Nice Racks~...Lol!!
You got it Jayman1980...OUT OF CONTROL FIREWORKS!!!
"REDSHIRTS" My Friend!!!
Board members I personally apologizes because I know we need to stay on the topic....FNMA will be fine just fine.
Semper Fi!! to you as well my brother...Wow!! Vietnam much respect and honor to you bro.
Brother No Way!!! I'm a retired Ordnance Chief - IYAOYAS!!!
Semper Fi!! USMCVET....I'm A Retired Marine, 24-1/2 and believe me that was almost too long.
Thanks stockprofitter I believe it's coming down to the wire on some serious decisions making for our crooks on the hill. Still a great deal of investing with large buys coming in daily....we'll se what tomorrow holds....HOLD STRONG FNMA!! JMO.
Everyone what does this mean? It doesn't sound like good news or is it?
FNMA: Sperling: WH not interested in GSE recap plan....
Excerpt from my email - "Speaking at an industry conference in D.C., Sperling says the administration is interested in rebuilding a stronger mortgage market not dominated by two mammoth institutions, and Frannie - even if restructured - would retain a large advantage over newer entrants". Seems like the PPS moved up after this....anyone?
I'm still at work and I can not get the article to come up on my computer.
Hearing today at 1:30 pm I believe it said June 20th, 2013.
Hey quimper27 we're speaking on the same note just different semantics and terminology. HEB is going somewhere positive in my own opinion. Brother I love debating it keeps the blood flowing and let's keep our eyes on the radar for HEB's advancement......Semper Fi!!
Go HEB!!!