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They are mutually agreed limitations. We do not know on who's request.
Unsubstantiated innuendo.
Just a little bit hyperbole
Good luck.
As for losing money, I am happy with what I made in the big run up in recent years.
In the intermediate period awaiting results, one can always play the technical game and still make money.
Somehow everything is thrown onto one pile and dr Kim is responsible for 33 years.
No he is not.
Look at his tenure, how he has turned it around, the multiple trials ongoing in p1/p2 and a p3 and the partnerships.
Jim Cramers most recent interview with dr Kim
Playing with disproved technology....
Mmm, dead wrong on that one. And DARPA, MedImmune, Genentech seem to agree with me.
Inovio Begins Phase 3 Clinical Trial of VGX-3100 for the Treatment of HPV-Related Cervical Pre-Cancer
FDA removes clinical hold on phase 3;
Inovio to immediately begin recruiting subjects
PLYMOUTH MEETING, Pa. – June 8, 2017 – Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced that it has commenced its phase 3 clinical program to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). Inovio’s study will assess the efficacy of VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions), a direct precursor to cervical cancer, and eliminating the HPV infection that causes these lesions. The pivotal data from this program will support the potential licensure of VGX-3100 as the first immunotherapy for this disease.
Inovio satisfied the FDA’s request for information relating to its CELLECTRA® 5PSP delivery device, resulting in the FDA removing the clinical hold on this program. Inovio plans to immediately begin recruiting patients for the phase 3 trial.
Inovio’s phase 3 program, named REVEAL (Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL), will consist of a primary study (REVEAL 1) and confirmatory study (REVEAL 2), as per FDA general guidance for phase 3 programs, to be conducted in parallel. The studies will each enroll 198 patients in more than 100 study centers globally. Mark Einstein, MD, MS, FACS, FACOG, Professor and Chair Department of Obstetrics, Gynecology and Women’s Health Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, is Principal Investigator for the studies.
The REVEAL studies are prospective, randomized (2:1), double-blind, placebo-controlled trials evaluating adult women with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3. The primary endpoint is regression of cervical HSIL AND virologic clearance of HPV-16 and/or HPV-18 in the cervix. The studies will evaluate cervical tissue changes at approximately 9 months after beginning a three dose regimen of VGX-3100 administered at months 0, 1, and 3. Secondary endpoints include safety; tolerability; regression of CIN 2/3 to CIN 1 or normal; virologic clearance of HPV; efficacy measured by non-progression to cancer; and clearance of HPV from non-cervical anatomic locations.
VGX-3100 has the potential to be the first treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and destroying pre-cancerous cells. There are no treatments available for HPV infection and surgery is the only approved treatment for cervical HSIL. While surgery is effective at removing dysplastic lesions, it does not treat the underlying HPV infection and carries increased risk of cervical incompetence and pre-term birth, which can result in fetal morbidity and mortality. VGX-3100 demonstrated in a phase 2b study (published in The Lancet) its ability to clear HPV-16 and HPV-18 infection and pre-cancerous lesions.
Dr. Mark Bagarazzi, Inovio’s Chief Medical Officer, said, “Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem. Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month.”
Dr. J. Joseph Kim, Inovio's President and CEO, said, “Initiating our REVEAL phase 3 program marks a milestone for Inovio, for the next generation of DNA-based immunotherapies, and for women’s health. Combining this first phase 3 program with our previously announced phase 2 clinical trial of VGX-3100 for HPV-related vulvar neoplasia and our checkpoint inhibitor-based combination study with MedImmune/AstraZeneca targeting HPV associated cancers, Inovio is well positioned to comprehensively treat HPV-associated diseases across the continuum of HPV infection through to cancer in both men and women. Adding our recently announced collaborative immuno-oncology combination studies with Regeneron and Genentech, 2017 is a transformative year that is laying the foundation for multiple opportunities for important efficacy data.”
Nothing obvious.
You are surely aware that people removed HIV-virus from their bodies without any drug and yet their are no HIV-cures.
Could something similiar happen with Alzheimer, perhaps. Very unlikely but neither can it be ruled out. And that is the problem with too small population size.
By the way efficacy was not a primary endpoint either, so bigger trials were always part of the bigger plan.
The odds are there.
Know of any other drugs that got approved based on n=19?
I don't and neither does Anavex.
Thats why they plan an n=300 p2/3.
Thats why Missling said that perhaps even more trials could be required
Perhaps you are right but that would include a lot of "if's" and nothing right now to support this theory.
I can only observe that there was a PR in Nov15 saying they are working with the FDA for a p2/3. Now in Jun17 we are still waiting.
"We are NEARING a PHASE 2/3 lady!"
I have been hearing that since Nov15 and now Its Jun17... seriously
So Missling should have ignored here question and get the message out he wanted. PR-for-dummies
On n=19??
Seriously, reality check please.
Perhaps when they can replicate it with n=300
To be whacked down again after AAIC? Parallel to July 16 or Nov 15?
When the PR was released last July the share price went from 8 to the 4-region in a matter of minutes.
Not for the faint hearted.
Weak hands sold right into the orchestrated attack.
You are right: the weak non-believers sell. I hold on to my shares and added after AAIC last July.
Oh goodie, another opportunity to add Anavex shares seconds after the PR is releases.
As I said, trials need time to generate results. There is no magic wand.
Nope nothing sad about it. We are in a quiet period where the multiple p2 trials are running or starting. Need to let them their work.
I tweeted TPIV last week when we could expect full p1 data and the answer was to listen to the webcast.
I like an efficient manufacturing production method :)
TapImmune completes successful multi-gram scale-up of TPIV 200
American Pharmacy News Reports | May 30, 2017
TapImmune will use this vaccine product for its ongoing Phase 2 study of TPIV.
TapImmune Inc. has completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, which is a multi-epitope T-cell vaccine developed by the company that targets the folate receptor alpha.
"The successful release of our second lot of TPIV 200 represents another important milestone in the progression of our product pipeline and technologies," Dr. Glynn Wilson, chairman and CEO of TapImmune, said in a statement. "Improvements to the manufacturing process include a process change to improve scalability and a formulation change to improve the physical appearance and consistency of the final vialed product. The end result is a superior formulation that is more amenable to large scale manufacturing and commercialization."
TapImmune will use this vaccine product for its ongoing Phase 2 study of TPIV, which measures how the drug treats platinum-sensitive ovarian cancer. The product will also be used for a planned Phase 2 study that targets triple-negative breast cancer and is sponsored by the Mayo Clinic.
TapImmune is an immune-oncology company that develops treatments for cancer. It focuses on innovative technologies and uses peptide or nuclei acid-based immunotherapeutics.
1,5h to go till market opens... will he release a PR or not?
FDA wants more shelf life data of the new medical device.
Bigger question is who bought them from LPC. A tute?
Shareprice does not seem to indicate that 5mil shares were dropped in the open market.
How large was the population size in the aricept trial?
I thought we would be getting loads of free cash from everybody. LPC was only a backup plan.
What changed?
Effective in getting a immune response in healthy people.
Not tried on actual HIV patients. Nor do we know how effective it is fighting the HIV-virus
Too much negative history to overcome regarding Alzheimer.
A little premature to cal HIV dead, but definatly encouraging data.
Each shareholder should be give a yearly amount of 2-73 to control their anxiety when having another panic attack about the shareprice.
Keep in mind this is a phase 1 trial, safety is primary endpoint, not efficacy.
Yet, great results.
And the next-gen device was use, you know the one FDA haltes to see How it stores over time.
How about curing first?
Prevention is the next level
Inovio HIV Vaccine Elicits Nearly 100% Immune Response Rates
in a Clinical Study
Amongst highest levels of immune responses ever demonstrated
in an HIV vaccine human study
PLYMOUTH MEETING, Pa., May 24, 2017 -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that its HIV vaccine, PENNVAX®-GP, produced amongst the highest overall levels of immune response rates (cellular and humoral) ever demonstrated in a human study by an HIV vaccine. The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody (humoral) immune response as well as a T cell (cellular) immune response to both potentially prevent and treat HIV.
These preliminary results are from a study supported by the HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in collaboration with Inovio. The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal (ID) or intramuscular (IM) administration in combination with a DNA encoded immune activator, IL-12 (INO-9012). Overall, 71 of 76 (93%) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens (env A, env C, gag, or pol). Similarly, 62 of 66 (94%) evaluated participants demonstrated an env specific antibody response. None of the placebo recipients (0 of 9; 0%) demonstrated either a cellular or an antibody response in the study. Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 (96%) participants demonstrated a cellular response and 27 of 28 (96%) demonstrated an HIV env specific antibody response.
Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 (100%) demonstrated a cellular response and 19 of 21 (90%) demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration.
This breakthrough data was presented at a plenary session at the 2017 HVTN Spring Full Group Meeting on May 23 in Washington, D.C. by the Protocol Co-Chair of the HVTN 098 study, Dr. Stephen De Rosa, Research Associate Professor, Laboratory Medicine at the University of Washington and Fred Hutchinson Cancer Research Center. The HVTN 098 trial was the first clinical study of PENNVAX-GP. The randomized, placebo-controlled multi-center study enrolled 94 subjects (85 vaccine and 9 placebo) to characterize and optimize PENNVAX-GP immunization regimens delivered through vaccinations using either intramuscular or intradermal delivery.
Dr. De Rosa, said, “The preliminary results of HVTN 098 are remarkable for a number of reasons. In HVTN 098, nearly all individuals vaccinated with the regimens including IL-12 had detectable CD4 responses and over half had CD8 T cell responses. Similarly, the antibody response rate was 100% or close to 100% for several of the env antigens tested in the assay. Thus, these high response rates are exceptional. Further studies will be needed to determine if this vaccine candidate can safely and effectively prevent HIV infection.”
Dr. J. Joseph Kim, Inovio’s President & CEO, said, “These results are among the highest ever responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose. We look forward to advancing PENNVAX-GP into later-stage clinical development with our partners and collaborators.”
Development of Inovio’s PENNVAX-GP immunotherapy, which widely targets multiple major clades of HIV — providing global coverage — has been funded through a $25 million NIAID contract previously awarded in 2009 to Inovio and its collaborators. In addition, Inovio and its collaborators were awarded an additional five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) grant in 2015 from NIAID.
About HIV Infection
Nearly 35 million people have died from HIV-related causes and over 36 million are living with HIV. HIV is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia).
HIV clade C accounts for 48% of worldwide and 51% of African-HIV type 1 cases. It is the most rapidly spreading subtype of HIV. Although highly active antiretroviral therapy regimens have dramatically transformed the treatment of the disease in developed countries, safe and effective HIV vaccines are needed to stop the spread of disease.
About Inovio's PENNVAX® HIV Vaccines and Immunotherapies
Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® immunotherapy technology. In two published phase 1 studies, PENNVAX-B immunization via IM injection generated high levels of activated and antigen-specific CD8+ killer T cells. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections.
Using a $25 million contract from the NIH, Inovio designed its universal, multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting the env, gag and pol antigens to provide coverage against all major HIV-1 clades. Inovio’s HIV development focus for both preventive and therapeutic purposes is on PENNVAX-GP.
About the HVTN
The HIV Vaccine Trials Network (HVTN), headquartered at Fred Hutchinson Cancer Research Center in Seattle, Wash., is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units.
About Inovio Pharmaceuticals, Inc.
Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron Pharmaceuticals, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
They better come with an update!
Hopefully better prepared so our shareprice is not attacked two years in a row.
I haven't heard it yet. Still await pk/pd to determine optimum p2/p3
Without PK/PD data, without and IND, don't think so!