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Results from phase 3 study on their website is neither mentioned as news or as a milestone, nor anywhere on line, makes it more difficult to understand the confusion.
A change of decision during non-official business hours of both the market and FDA means he either needed time to find a solution to the problem over a phone call, while knowing that it is a quick fix up, or he finally understood how misleading his statement was. The first would be preferred, as the second will probably not only take longer to resolve but it will also reflect mistrust.
“After the Company has met with the FDA and the Agency is able to provide greater clarity to the issues raised in the CRL, Elite will host a conference call to discuss the pathway forward for SequestOx™.
thanks, that is more like it. The pre market conference will give an opportunity to calm things down and allow share holders to decide for themselves what the next move should be.
That all sounds fine and dandy, but like you said, if he had come out with the issues raised by the FDA in the CRL, without the need to speak of a solution to the problem at the moment. But share holders should have the right to know information that is public to them, so that they can make adequate decisions when it comes to their money.
Not sure, but what I do know is that as part of the deal, the buyers acquired Epic’s FDA and U.S. Drug Enforcement Agency–inspected Good Manufacturing Practice (GMP) manufacturing site, a 110,000-square-foot facility in Laurelton, NY. That will add 215 employees to the Humanwell and PuraCap U.S. operations team.
not as simple as a site approval, since it was out of their hands in the first place once Epic, the intended manufacturer, was sold to China. The CEO could have simply said that in the first place the morning of news, but instead delayed it to after hours with no explanation.
My thinking to the FDA objection at this time might come from the lack of information from the CEO and the known information when combining naltrexone.
There are major concerns by doctors when prescribing naltrexone, to ensure the treatment is safe on a patient. Blood tests are usually obtained prior to initial treatment with the drug, followed by retesting which generally occurs at monthly intervals for the first three months, with less frequent testing after that point. More frequent testing may be requested depending on the health of the liver prior to beginning treatment. Blood tests are needed to make sure that liver function is adequate prior to taking naltrexone and during, to evaluate whether naltrexone is having adverse effects on the liver. In addition, a patient should inform their physician of whatever medication they are currently taking so that possible interactions can be evaluated. Because naltrexone is broken down by the liver, other medications that can affect liver function may affect the dose of naltrexone.
Those are problems that need to be a dressed before a doctor deals with a pain by prescribing SequestOx, in case the patient consumes alcohol and the naltrexone gets released. All that can cost time and money to insurance companies as well as it creates a bigger burden to doctors.
Again, since the CEO lacked information, I have to gather my own in order to make an intelligent decision. If anyone can better explain the above, your response is welcomed.
The dangerous part of all that is the amount of outstanding shares and the fact that more will be added. That becomes an obstacle when trying to uplist, resulting in a possible reverse split where the amount of shares owned would be significantly reduced.
Part of a CEO's job is to inform shareholders and you saying to an extent is not good enough. Honesty is what's important so that share holders can make their own decision. He knew the reason for the CRL, however, his priority was not to fix the deficiencies and gain approval since that will take time, but his priority was not to loose many shareholders over the weekend by using uncertainty on his PR due to lack of information which does not allow a shareholder to make a better decision with the market being closed for two days. Honesty is what's required when meeting of Board of Directors, so why the same can not be asked of a CEO for its share holders.
The FDA are very punctual with their calendar. As you've stated, if a CRL was needed the FDA does not waste their time holding information.
Also, good news always reads better on Mondays and bad news on a Friday.
They can not PR until FDA post on website.
that's the way it always works in the market when FDA approval is pending, no reasoning behind it other than money to be made.
correct, hence the SEC filling the day of approval as a probable sign that they know and are getting ready to capitalize on it.
or maybe the S-1 is to dump on the market after the sudden brief upward movement of the stock that will take place in a few.
The minute Elite gets FDA Priority Review Designation on March 17, Humanwell Healthcare Group and PuraCap Pharmaceutical LLC announced that the companies entered into a definitive agreement to acquire 100% of the membership interests of Epic Pharma on March 31. The acquisition further establish Humanwell and PuraCap in the US generics market and expanded their existing commercial and manufacturing capabilities, including SequestOx.
Coincidence, I don't think so, everything is ready for an approval.
Actually I do, plenty of it for many years. Always at work at 6 AM, since that's how I get the pulse of the market for the day. However, never with the OTC market. Today I am making an exception and for a moment the first ask was at .68, which is close to .70 the target I am aiming for. Expecting approval, thank you for asking.
This month FDA decided not to hold an Advisory Committee meeting for DURECT Corp.'s Remoxy, an abuse-deterrent formulation of oxycodone, and to retain the Sept. 25 PDUFA date, after Remoxy was up for an AdComm on August 5th, which was previously requested by the FDA to garner more information.
“The cancellation suggests to us that after
having three months to review the Remoxy NDA, the FDA concluded that it did not need expert advice to render its decision after having reviewed two prior NDAs where the only unresolved issue
had to do with manufacturing.”
"We believe this suggests that the efficacy and safety profile of Remoxy has been well presented in the NDA (new drug application) package, from the FDA's perspective...therefore, in our view, Remoxy is likely to secure regulatory approval in September"
It seems the FDA is willing to quickly approve alternatives as long as they satisfy all protocols.
you hit it on the nail
it seems the charts already know, if taking a look at the monthly analysis.
It seems the stock has been halted since 5 pm because it has not shown any bid or ask price. Most likely news for pre market.
thanks I was not aware, either is covering or accumulating shares, either way it looks promising.
nice bid at .34 getting ready for news
Doctor D, you are correct by saying Elite is getting ready to unload, since they will need money for production. According to the agreement they can choose at what price to sell and the best time to get it is after approval.
"Under the terms of the agreement, there are no upper limits to the price that LPC may pay to purchase Elite's common stock. Elite will control the timing and the amount of shares to be sold."
I don't think it will explode because of that. The price will increase on its own, like it has done in the past few days. However, an update can help as confirmation that the concept is well on track.
any abstract information that supports the study will be potentially impactful for its future. According to the abstract, ImmunoPulse IL-12 'can prime response' to anti-PD1/PD-L1 blockade in patients. The statement is very important if Dr. Alain Algazi along with UCSF are continuing with the study and can now support the thesis. Important because it will give investors a support, from a very low base, in which to build upon.
Yes, it seems like new data concerning the combination with Keytruda.
UCSF and OncoSec are collaborating in evaluating the combination of ImmunoPulse and anti-PD-1 treatment. The Phase II clinical trial is being conducted by Dr. Alain Algazi.
Dr. Alain Algazi has said, “The PD-1 antibody pembrolizumab takes the brakes off of the anti-melanoma immune responses. ImmunoPulse with IL-12 has the potential to bring immune cells and signals into the tumor so that, when pembrolizumab takes the brakes off the immune response, the results could be devastating for the tumor and great for our patients.”
Session Title at the AACR annual meeting: Early Clinical Trials Evaluating Cell-based, Checkpoint Inhibitors, and Novel Immunotherapeutics
Session Type: Clinical Trials Minisymposium
Session Start/End Time: Tuesday, Apr 19, 2016, 3:00 PM - 5:00 PM
Location: Room 343, Morial Convention Center
CME: CME-Designated
Presentation Abstract
Chairperson: Dr. Paul C. Tumeh. UCLA Medical Center.
Title of abstract to be presented:
Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma
Author Block:
Alain Algazi, Katy K. Tsai, Kathryn T. Takamura, Lawrence Chen, Chris Twitty, Mary Dwyer, Samantha Greaney, Tu Diep, Robert H. Pierce, Mai H. Le, Lawrence Fong, Adil Daud , University of California San Francisco, Sa; OncoSec Medical Incorporated.
TriMixDC-MEL Plus Ipilimumab Active in Pretreated Advanced Melanoma. (published March 1)
"Autologous monocyte-derived dendritic cells (DCs) electroporated with synthetic mRNA (TriMixDC-MEL) in combination with ipilimumab was tolerable and resulted in highly durable responses in patients with pretreated advanced melanoma, a study published in the Journal of Clinical Oncology has shown.
TriMixDC-MEL have previously been shown to be immunogenic and have antitumor activity in patients with pretreated advanced melanoma. Because ipilimumab, a cytotoxic T-lymphocyte-associated protein 4 antibody, improves overall survival in patients with advanced melanoma, researchers sought to investigate the combination of both in the pretreated population.
For the phase 2 study, researchers enrolled 39 patients. All participants received TriMixDC-MEL 4 × 106 cells administered intradermally and 20 × 106 cells administered intravenously, plus ipilimumab 10 mg/kg every 3 weeks for 4 doses. Patients who remained progression-free then received maintenance therapy every 12 weeks.
Results showed that the 6-month disease control rate was 51% (95% CI, 36 - 67) and the overall tumor response rate was 38%.
Eight patients achieved complete responses and 7 had partial responses. Of those, 7 complete responses and 1 partial response are ongoing after a median follow-up of 36 months.
In regard to safety, the most common treatment-emergent adverse events were local dendritic cell injection site reactions, transient post-dendritic cell infusion chills and flu-like symptoms, dermatitis, hypophysitis, diarrhea/colitis, and hepatitis."
Keep in mind that IL-12 naturally increases mRNA.
well I do, I understand that not every one will think the same way that I do, and I respect their opinion. By the way, I was only repeating what you wrote. You said that investors basically put money on companies that work on real diseases and have real science. Excuse me if I misinterpreted what you stated.
He definitely was a person to admire. At a very young age, he accepted his destiny and took it upon himself to make a difference. He will rest in peace.
That's why we agree to disagree when it comes to Oncosec. You do not consider melanoma a real disease or Triple-Negative Breast Cancer for that matter. In addition, you feel that electroporation is not science, however, it has been an extremely helpful method to understand cells in clinical research for the last two decades. Overall delivery (especially in vivo) is still the major problem, and although many approaches have been tested, very few of them work. That's why viruses are still considered the natural perfect delivery machines. For that same reason, I support the work Oncosec has shown in their in vivo studies with EP IL-12. Go back and read the results and compared them with any other study using the same interleukin.
How much is it worth saving the life of a child?
Sickle cell disease is the most common of the hereditary blood disorders. It occurs almost exclusively among black Americans and black Africans.Sickle cell disease in black Americans occurs in about 1 in 500 live births.
Children are the most affected by the disease due to their low immune system, which eventually leads to death. Bone marrow transplant offers the only potential cure for sickle cell anemia. But finding a donor is difficult and the procedure has serious risks associated with it, including death.
Treatment for sickle cell anemia is usually aimed at avoiding crises, relieving symptoms and preventing complications. Both BLUE and GBT are looking to do more than just dealing with the symptoms. They are trying to get approaval of an orphan drug to cure the disease. To date the FDA has approved only one drug for treatment of sickle cell anemia, an old drug calledhydroxyurea. Given the chronic and often debilitating nature ofsickle cell disease, which variably affects some 100,000 people in the United States and millions worldwide, there’s a pressing need for better therapy.
There are many organizations currently supporting studies for a cure through donations.
Knowing about bios means understanding why the share price drops or why it goes up significantly. The two companies mentioned have a good reason to why their price is higher than Oncosec's.
BLUE's cash equivalents and marketable securities as of December 31, 2015 were $865.8 million, compared to $492.0 million as of December 31, 2014, an increase of $373.8 million, which was primarily driven by the June 2015 equity financing partially offset by cash used to fund operations.
GBT cash and cash equivalents totaled $158.5 million at September 30, 2015 compared with $52.1 million at December 31, 2014, reflecting the $126.2 million of net proceeds from their initial public offering in August 2015.
It open last year its IPO at $46 and now it is $14 and most likely it will continue to drop.
Oncosec has not proven anything of value yet, they are in the middle of that. However, they have published studies that is allowing them to move forward with what is so much desired.
It is very simple to understand, as long as one understands how biotechs work with the market. Oncosec is now focusing on their first product, after trying to figure out how to develop its pipeline in the past. This takes time and professional traders will take advantage. As long as the company is able to aquire money by moving their science forward with data, their least concern is the share price. It will go up when it needs to go up. Take for instance the company Geron, that tried to jugle more than one product at a time, but now it is only focused on a very important enzyme that is practically owned by Janssen. They received 35m upfront with future payments and the share price has tanked ever since, even though Johnson And Johnson know exactly what they are doing when it comes to marketing new products.
Oncosec is using an old technology, together with a highly toxic interleukin, that has never been used in the market. So far, not only have they shown it works but more important ithelps with toxicity. And they are not the only ones trying to achieve this.
From a published abstract that I previously posted for you:
"In summary we show that NM-IL-12 has excellent anti-tumor potential when used preclinically in combination with standard of care anti-cancer treatments, including radiation, chemotherapy and immunotherapy. NM-IL-12 is expected to contribute durable anti-tumor responses in the clinic through potent immunoactivation and anti-angiogenic effects, and to replenish blood cells, while being safe, well tolerated and non-immunogenic."
As you can see, combinations with IL-12 have already being tested with standard of care in preclinical, and results are positive. The study also tested IL-12 in combination with anti PD-1 as immunotherapy and results were good as well.
"PD-1 blockade elicits potent anti-tumor immunity in a subset of melanoma patients. We have thus evaluated the combination of rMuIL-12 and anti-PD-1 antibody in a clinically relevant, syngeneic model of spontaneous, highly metastatic B16 mouse melanoma has been tested"
Keep in mind that Oncosec's study will include patients with low TIL as well normal, so not only will they be able to find out about nonresponders but also how well can electropration together with IL-12 synergize the anti PD-1.
You said that they were not institutes, which they can be but you would not know that and I said that they needed to be savvy, continuing to what TomP wrote.
My guess is that they are intitutes, since most began opening positions somewhere between $5 and $8, and it will take a while to get passed above that for them to gain some profits. That would make them long term, since it has been almost a year. And even if they are trading or have shorted they are still around. So according to your understanding of traditionally, that would probably make them institutes. Keep in mind, the work that Oncosec is pursuing in immunotherapy is a long term deal that can bring a lot of money in the future to some institutions.
What does not really mean?
According to the definition, a hedge fund is an investment fund that pools capital from a limited number of accredited individual or institutional investors and invests in a variety of assets, often with complex portfolio construction and risk management techniques. It uses high risk methods, such as investing with borrowed money, in hopes of realizing large capital gains.
It sounds to me like they need to be some what savvy.
When Dhillon mentions clinical data that supports Immunopulse IL-12 and anti PD-1 as a rational therapeutic combination, he is referring to data already released from the melanoma and merkel carcinoma studies. On the Q4 2015 Earnings Call Dr, Pierce said the following,
“In summary, preclinical data as well as our clinical data for melanoma and Merkel cell carcinoma trials provide evidence that ImmunoPulse IL-12 functions as an in situ vaccine leading to the generation of CD8 positive T-cell directed against tumor-associated antigens including critical neoantigens. These tumor-specific T-cells then disseminate and attack non-treated distant tumors.”
Now, I know you are very skeptical and I do understand why, however, let’s keep an open mind to what Dr. Pierce has said. After all, before he joined Oncosec in 2013, Dr. Pierce worked on the Keytruda program with Merck, where he was in charge of a group that focused on non-responders to anti PD-1. The research led to collaboration with Dr. Tumeh and Dr. Ribas at UCLA, and a scientific paper that was later published, allowing for the research to continue forward utilizing Dr. Pierce’s patent on assays.
“Our job was to figure out why some patients are predisposed to respond and others are not. Now with these results researchers can develop better drug combinations that are more effective, less costly and with fewer side effects”, said Dr. Ribas after discovering why some patients respond to the life-saving melanoma drug of Keytruda. A scientific paper was published, allowing their research to move forward in collaboration with Oncosec, Perkin Elmer and UCLA.
My reasoning to believe that EP IL-12 works well with a combination starts with the fact that I am not a scientist. That is why I trust those three doctors, who by the way do not have any common interest other than the search to find a cure for the non-responders.
In both Oncosec’s previous studies, for melanoma and merkel cell carcinoma, ImmunoPulse IL-12 converted the tumor from a low-TIL non-responder to a high-TIL responder phenotype. A marked increase in a tumor-specific CD8 TIL population was observed after ImmunoPulse IL-12 treatment, more importantly that it was not only in treated tumors but untreated as well. This T-cell expansion correlated with a generation of a deep clinical response.
“Taken together, these data provide evidence that ImmunoPulse IL-12 is helping the immune system to recognize and attack the tumor.” Dr. Pierce.
What study did you just posted? Is that Oncosec's electroporation?
because in their study I find the following, "there were no treatment-related serious adverse events reported." By the way, toxicity is very serious when it comes to IL-12, it can kill a person. Those are not serious and no hematologic abnormalities observed is very good.
Yes, you are correct, other companies as well as scientific institutions have tried working with IL-12. As a matter of fact that's the type of research that I like to conduct. But earlier you said that other studies do not matter you only care for Oncosec's released data. But lets take a look at your research given on that med search engine link. The first study that shows the use of IL-12 in melanoma is titled 'Defining the Pharmacodynamic Profile and Therapeutic Index of NHS-IL12 Immunocytokine in Dogs with Malignant Melanoma'
OK, so I picked the first of the list and it says the following:
Eleven dogs were enrolled in four dose-escalation cohorts; thereafter, an additional seven dogs were treated at the defined tolerable dose of 0.8 mg/m2. The expanded cohort at this fixed dose (ten dogs in total) was accrued for further pharmacokinetics and pharmacodynamics assessment. NHS-IL12 levels, serum cytokine concentrations, and peripheral blood mononuclear cell characterization (post-treatment) and draining lymph node immune profiling, and tumor biopsies (pre- and post-treatment) were collected. Adverse events included thrombocytopenia, liver enzymopathies, and vasculitis which are all due to toxicity and fevers which is how the body tries to respond to them.
CONCLUSIONS/SIGNIFICANCE:
NHS-IL12 was administered safely to dogs with melanoma and both immunologic and clinical activity was observed. This study successfully defined a narrow therapeutic window for systemic delivery of NHS-IL12 via the subcutaneous route. Results will inform the design and implementation of first-in-human clinical trials of NHS-IL12 in cancer patients.
Everyone on this forum that visits regularly should be aware by now the difference of what Oncosec is doing to deal with toxicity, since it is what makes Dr. Richard Heller’s invention the center of their studies.
So let’s take a look at Oncosec’s melanoma Phase2 effects using IL-12 at a much smaller concentration of 0.5 mg/mL
There were no treatment-related serious adverse events reported.
Transient pain and inflammation at the treatment site were the most common grade 1/2 drug-related adverse events (AEs), with no grade 3/4 drug-related AEs. Exploratory analyses indicate a doubling of intratumoral NK cells from pre-treatment through day 11 and at day 39, and increased frequency in activated circulating NK cells.
Intratumoral treatment with IL-12 EP resulted in the development of a systemic anti-tumor effect in the majority of patients.
“IL-12 appears to ‘de-cloak’ the tumor, allowing the immune system to see the tumor as ‘foreign’ and generate the CD8 T cells needed to mount an attack. These findings are incredibly important given the emerging understanding that a prerequisite for response to T cell checkpoint therapies such as anti-PD-1 mAbs is the presence of the PD-1+ CD8 T cells”
Oncosec showed that they can deliver IL-12 into the body without toxicity, did you thank them for that?