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Want to know how Oncolix will work out? Just look at what Redman did with Opexa, one of the companies that he founded. Ended up getting bought out and is now trading on the Nasdaq!!!
If history is any indication for how things will turn out here, it's looking like it will be a huge success and we are all going to make a ton a money!!!
GO ONCX!!!
Want to know how Prolanta will work out? Just look at what it's inventor did with Somavert. FDA approval!!!
BRIGHT FUTURE HERE!!!
GO ONCX!!!
Looks like another failed lawsuit attempt:
https://www.lexislegalnews.com/articles/9832/judge-investors-failed-to-plead-misrepresentation-scienter-in-securities-suit
Stop lying! Michael Redman has already confirmed they still use BioVectra. Where is your source that the contract expired? It's even on the Oncolix website listing BioVectra as the contract manufacturer.
Email response from Redman regarding the difference between G129R and LFA102:
"LFA102 and Prolanta have very little in common other than they are both targeting the prolactin receptor. Both drugs have different mechanisms of action, one is a therapeutic protein and the other is a monoclonal antibody. The mechanism of actions are different - ours is autophagocytosis (or autophagy) but I am not aware of the mechanism of action of the Novartis drug. Our drug is under evaluation for ovarian cancer and LFA102 targeted breast and prostate cancer. The chemical structures are completely different and the molecular weights are not identical. Our drug features a glycine to arginine substitution at the 129th position, which causes a competitive inhibition that blocks dimerization of two prolactin receptors. Our drug only binds to one receptor and pushes the second receptor farther apart, which causes a completely different signaling pathway (PEA15) to induce autophagy. The monoclonal antibody does not work in this fashion nor does it feature a amino acid substitution similar to Prolanta.
A good example to follow is the PARP inhibitor products. They all have the same mechanism of action and are all close cousins. However, there have been at least three dismal failures in Phase 3 and three products that have made it to Phase 3 or approval. It just shows that all drugs, even within its therapeutic class, are not equal.
We are evaluating Prolanta in a dose-escalation trial - 0.5, 1.0 and 2.0 mg/kg. We were actually surprised to see evidence of efficacy at the lowest dose in an ovarian cancer population that normally responds to little to no treatments. The first-in-man (or woman) trials generally are restricted to patients that have failed multiple treatments and are terminal. Keep in mind that the primary endpoint of a Phase 1 trial is safety. However, it is icing on the cake if you observe evidence of efficacy, which is what we have observed in the low-dose patients.
In our non-human primate toxicology studies, we dosed up to 12 mg/kg and noted no adverse events. To date, the only side effects that have been observed related to the drug are itchiness and redness at the injection site, according to our principal investigator.
Michael"
You're right, we don't know who the manufacturer is going to be. But we do know that they have BioVectra if need be as they are still under contract. So it's not a matter of if they will be manufacturing more Prolanta, but who will be manufacturing it. As per that email, it looks like they are bringing on another manufacturer.
I'm not in a rush and have confidence everything will get done in a timely manner.
The management team and advisory board in Oncolix are as legit as can be. These guys know what they are doing. Redman has already been there and done that with a public company that went all the way to Nasdaq.
IMO
Redman just confirmed they still use BioVectra:
https://imgur.com/gallery/1Y7Zy
Because if they've switched manufacturer's that's material information that needs to be disclosed in proper fashion. But again, there is no reason to believe that BioVectra is no longer in the picture.
IMO
Yes, obviously in order to manufacture a drug you need a drug manufacturer. It also said in the filings that they would be evaluating other manufacturers. Probably to make sure they are getting the best pricing and company to work with.
Until we hear otherwise, there is no reason to assume that Oncolix does not have BioVectra as a manufacturer. It's possible they won't be using them, but that doesn't mean that they aren't still under contract or partnered with them anymore.
The Oncolix website is brand new and still lists BioVectra as their contract manufacturer. If they terminated that agreement, wouldn't you think that they would take it off the website?
Here's the quote from the website:
"The contract manufacturer for Prolanta is BioVectra Inc., Prince Edward Island, Canada (USA FDA Registration No. 3004063541)."
Here's the link to the website: https://oncolixbio.com/our-science/prolanta-structure/
I have yet to see anything that says their contract investment agreement with BioVectra has been terminated. What out there would lead anyone to believe that BioVectra is no longer a player for production of Prolanta?
You might be waiting a while... ZzZzZzZzZz
We already know they have BioVectra as a manufacturer in their back pocket. Their former President is on our board and we have a history with them. There have been recent advancements in manufacturing technology that may lead to more efficient drug production. New advancements would mitigate costs and increase the amount of the drug produced. It's very possible they have moved on from BioVectra, but could still use them if need be.
It would be crazy to think Oncolix doesn't have someone to manufacture the drug. I believe Oncolix will have or already has multiple manufacturers to limit exposure to risk and to get more competitive pricing options.
Why put all your eggs in one basket when there's the risk that a manufacturer may not be able to come through for various reasons? Reasond such as the FDA shutting them down or a major logistics issue.
They did state in a filing a while back that they may be considering other manufacturer options. If they did decide to switch, they wouldn't be able to disclose a new material event in anything other than an 8-K and PR. This shouldn't be a worry to anyone as the company has had a year to plan everything out. They have a more than competent and experienced management team and advisory board. We will learn sooner rather than later what their plan is.
As Redman has stated, they are in the process. We should be hearing something soon.
IMO
Also, the former President of BioVectra, Dale Zajicek, joined the Oncolix board of directors in October.
Redman email responses regarding the manufacturing of Prolanta:
https://imgur.com/gallery/tj9ik
I would have to assume it's being manufactured. Not sure we will get preliminary data by January 2018. I'm putting my money on February/March 2018 for that. I'm sure we will get a PR regarding all of this shortly.
IMO
They also didn't convince savvy venture capitalists to invest $15m+ if they didn't have a drug that they were confident in. There's definitely a lot of potential with Prolanta and it's been extremely well researched, studied, and documented. A lot of us were children when the research originally began back in 1999.
Prolanta's inventor has already created one successful drug with Somavert, which is nearly identical to Prolanta. Somavert is able to successfully antagonize HGH. Prolanta is designed to antagonize PRL. PRL and HGH are both structurally similar pituitary hormones. Knowing this information, one can guess that Prolanta has a strong probability to follow suit.
We already know that Prolanta isn't showing any adverse effects, and from what has been communicated by Oncolix, is alreasy showing signs at low doses that it's potentially efficacious.
Do the math.
Yes that's true. I have no reason to believe that Redman and Oncolix won't follow through on the trials.
False. A reverse merger is more like a hostile takeover, but with a SPA agreement that allowed Oncolix to become majority shareholders of AEPP and also the decision makers. If you read the filings, they had Kistler resign as part of the deal and he no longer has any affiliation with the new entity which is known as Oncolix.
It might technically be "dilution" but the float remains unchanged until at least August 2018. Those 10m are held by insiders.
Nothing to see here.
Oncolix is currently recruiting patients for the continuation of their Phase I. The issue with Oncolix has not been a shortage of patients, it has been a shortage of their drug, Prolanta.
They had enough patients ready to go for Phase I back in 2016, but were only able to bring 3 of those patients to completion. The reason they had to stop was due to the shortage of Prolanta as mentioned above. This information can be verified by calling Lisa Johnson, which I've done, who is listed on the the trial page information that you copied and pasted.
Why was there a shortage of the drug? One can only assume they had their financing sources fall by the wayside. Now that Oncolix has gone public they can fund their operation via the sale of securities.
As the company has stated and Lisa Johnson has verified, they did start phase I in 2016 and were able to compete 3 patients in that initial run. I emailed the CEO, Michael Redman, and asked him why the trial page had been updated in April 2017, but still remained in a recruiting status, and this was his response:
"Normally you do not update the site until you have audited data. Much of the biomarker work will be performed once we have dosed all the patients. Remember, the primary endpoint for a Phase 1 study is safety but it is always good to observe evidence of efficacy. So far, no adverse events due to the drug have been reported."
And they are probably going need another $30m-$50m to get through Phase III. I personally believe that Redman would try to position the company for a buyout or partnership with a major pharmaceutical company before then. He already had one of his companies bought out and ended up on the Nasdaq way back in the day.
I don't see how he can keep raising the money through selling stock. I think he has to partner or get bought out. The institutional investors who have 70%+ of the voting power will not let Redman dilute their millions into oblivion.
I believe they are banking on positive phase I results to get them in a position where they can pull this off.
IMO
Hey I appreciate you looking into this. Idk how much research you've done outside of the current filings, but this isn't the first time Oncolix has raised money. When Oncolix was private, they were able to raise somewhere between $15m-$20m in venture capital. That's not $100m, but it's pretty good considering how small of a company they are.
Lololol okay good luck :)
This isn't a newly formed company. They've been around for 10 years and there are countless publications, studies, and trials in regards to their science. They just went public only this year. There is plenty of solid DD backing their legitimacy. I mean the company has 34 total patents between US and international for Prolanta. And they won't be a Pink sheet for long as they are currently in the process of uplisting to the OTCQB.
Do a little bit of DD before you jump to conclusions. I understand it's easier to be skeptic of OTC companies.
Call GHS/ITOR where the clinical trials are being held. They had tested a lot more than 3 patients but could only bring 3 to completion due short supply of Prolanta. The drug is extremely expensive to manufacture and is probably the driving factor for bringing the company public to have access to more capital and equity. They had burned through $15m+ in venture capital up until this year.
Yes and that peer reviewed published clinical data will be released when the trial has concluded. But even you yourself had a little bit of positive news that you learned about Prolanta through a source that you are unwilling to name. And that has had an impact on you.
The company lists only 3 patients because they only had enough of the drug to bring 3 to completion. The initial phase I had many more than that enrolled and tested on and that was what was told to me by Lisa Johnson who is one the main people overseeing the trial.
But soon we will know as all data will be released at some point in the near future. It's just a waiting game at this point.
Okay well maybe efficacy isn't the right word to use if there is a technical component to which is a complete unknown to us at the moment. So for the time being we will just say that patients conditions were 'improving'. There were a lot more than 3 patients enrolled and tested according to Lisa Johnson, and also according to her, all of the patients were 'improving'. Not my words, hers.
The other thing that is intriguing about Oncolix is the fact that Ernest Mario is invested in the company. Ernest Mario is the former CEO of GlaxoSmithKline GSK.
Also, the inventor of Prolanta, Wen Chen, also invented Somavert, which is a drug that gained FDA approval, for people who have HGH disorders, for Pfizer.
Somavert, which is known as G120R, is a growth hormone receptor antagonist. This drug was able to successfully inhibit growth hormone receptors to help patients who have growth hormone disorders.
Prolanta, which is also known as G129R, is Wen Chens other invention. He developed both G120R and G129R around the same time period using the exact same amino acid substitution method. These drugs are almost identical to each other. The other interesting fact is that the structure of prolactin is similar to that of growth hormone and placental lactogen.
So here you have 2 identical drugs that are antagonists for 2 hormones that are very structurally similar to each other. Inhibiting human prolactin may be effective in antitumor activity because of its role in the presence and growth of cancerous tumors. The other issue with human prolactin hormones is that they also contribute to humans becoming resistant to chemotherapy. If you can antagonize the human prolactin receptors and hormone, you can at the very least increase the efficacy of chemotherapy, which in itself would be a major breakthrough.
So in conclusion, knowing that we have 2 almost identical drugs working to antagonize structurally similar hormones, we can hypothesize that both would be almost equally effective. One drug, Somavert, has already achieved FDA approval, and the other drug, Prolanta, has a strong probability to follow suit.
Here's an article that contains information regarding the similarities of the prolactin hormone and growth hormone:
https://link.springer.com/chapter/10.1007%2F978-1-4757-3600-7_7
They are both pituitary hormones with structural similarities. Somavert was able to become a successful antagonist to HGH and Prolanta is a nearly identical drug and will more than likely be a successful antagonist to PRL.
Successful antagonism of PRL doesn't guarantee antitumor activity as a monotherapy, but knowing PRL's role in cancer patients resistance to chemo, it's almost guaranteed to improve the efficacy of the chemo, which would be a major breakthrough.
What we do know, based on what Redman has said and also what Lisa Johnson told me over the phone when I called GHS/ITOR, is that Prolanta, as a monotherapy, is showing efficacy.
But either way, you can call the clinic where the Oncolix trials are taking place and they will tell you that in the initial phase I, efficacy was observed as in anti-tumor activity. So it's a statement that holds truth and theres no way around it. Observing efficacy in phase I is just a bonus on top of what is the main purpose of phase I, which is to find out the safety and tolerability of the drug.
Well there's one study that was done regarding their drug and it's efficacy where they were tested it in vivo in orthotopic model. Tumor weights were reduced by 50% as a monotherapy and 90% when used in conjunction with chemotherapy. This study as also talks about the method of action by G129R which is known as autophagy (programmed cell death). Autophagy made headlines in 2016 as a scientist was awarded the Nobel Prize for his work and discoveries with autophagy.
Here is the link to the Oncolix study regarding G129R dated back in 2014: http://d-scholarship.pitt.edu/24726/1/1-s2.0-S2211124714001879-main.pdf
They certainly weren't trying to pump any stock back in 2014 when they just went public this year. At least I don't think they were.
Not true. Companies will note whether or not there has been efficacy observed in a Phase I trial. Check out the Novartis Phase I trial results for their drug LFA102. They noted as part of their results that there wasn't any efficacy or antitumor activity observed.
I've also personally called GHS/ITOR and was given the same information regarding efficacy and antitumor activity in the Oncolix phase I trial for their drug Prolanta. These statements have also been made by the company before they ever went public, so they clearly weren't saying that to sell stock.
And it wouldn't make sense not to check on whether or not a patients condition is improving when they are dying from a late stage ovarian cancer. These people may only have months to live, so obviously their doctors are going to be monitoring their cancer. If they notice during phase I that the patients are improving, they can conclude the phase I doses are showing efficacy.
Even when you go to aeppinc.com it's still listing AEPP as it's ticker symbol. Tell me that wouldn't be confusing or seem like a red flag to a new investor? It's nice to be distanced from that now.
I still believe name change and ticker change is a catalyst in the sense that when new investors find this ticker, it may give them the confidence to invest here. More confidence investing in something that looks legit instead of investing in a petroleum producing pharmaceutical company (Red Flag). A lot of people will only do surface level DD and they may not realize that's there been a reverse merger and probably won't put forth the effort to dig through the plethora of filings that have been released since the beginning of this year.
I think it can lead to more buys over the course of time and a gradual move up. Not going to create a rocket ship parabolic move, but branding the stock to be consistent with the underlying business is important. As we have seen, it's time consuming and a lot of work. One would probably think of a company as being more legit if they were willing to go through the whole name change and ticker change process.
IMO
Yes that is true, but they did observe efficacy (anti-tumor activity) in the initial phase I human study. The drug was also well tolerated with no adverse effects. And because of the structure of the drug, they don't believe and they will be any dose limiting toxicities.
The company was founded in 2006: https://oncolixbio.com/about/management-team/
https://www.crunchbase.com/organization/oncolix
http://www.bioworld.com/content/oncolix-seeks-funding-prolactin-antagonist-trials-0
The drug Prolanta or G129R has been researched and studied by its inventor, Wen Chen, who is also an advisor to Oncolix, since 1999: https://www.ncbi.nlm.nih.gov/pubmed/10589775
https://www.ncbi.nlm.nih.gov/m/pubmed/11894130/
https://www.ncbi.nlm.nih.gov/pubmed/14647416
This is a report published in 2014 about the clinical studies/trials that were conducted on xenograft mice:
http://www.sciencedirect.com/science/article/pii/S2211124714001879
Video interview with Michael Redman:
I'm not BSing you. Have you done any research into this company beyond S-1/A?
They've been in business since 2006. They raised between $15m-$20m in venture capital to fund their operations up until this year. They have the backing of the Texas Treasury Safekeeping Trust and Greenville Healthcare System. Mario Ernest Glaxo the former CEO of Glaxo Smith Kline GSK is an investor here.
They have 34 US and international patents for their drug Prolanta. They have already shown promising results in xenograft studies and in the first set of human trials in Phase I which they are looking to continue.
Prolanta Science:
Wen Chen (Prolanta Inventor)
He also invented Somavert which is known as G120R. Somavert was successfully brought through trials obtaining FDA approval and is now sold on the market by Pfizer. Somavert (G120R) is a growth hormone receptor antagonist. This drug was able to successfully inhibit growth hormone receptors to help patients who have growth hormone disorders.
Prolanta also known as G129R is Wen Chens other invention. He developed both G120R and G129R around the same time period using the exact same amino acid substitution method. These drugs are almost identical to each other. The other interesting fact is that the structure of prolactin is similar to that of growth hormone and placental lactogen.
So here you have 2 identical drugs that are antagonists for 2 hormones that are very structurally similar to each other. Inhibiting human prolactin may be effective in antitumor activity because of its role in the presence and growth of cancerous tumors. The other issue with human prolactin hormones is that they also contribute to humans becoming resistant to chemotherapy. If you can antagonize the human prolactin receptors and hormone, you can at the very least increase the efficacy of chemotherapy, which in itself would be a major breakthrough.
So in conclusion, knowing that we have 2 almost identical drugs working to antagonize structurally similar hormones, we can hypothesize that both would be almost equally effective. One drug, Somavert, has already achieved FDA approval, and the other drug, Prolanta, has a strong probability to follow suit.
Here's an article that contains information regarding the similarities of the prolactin hormone and growth hormone:
https://link.springer.com/chapter/10.1007%2F978-1-4757-3600-7_7
They are both pituitary hormones with structural similarities. Somavert was able to become a successful antagonist to HGH and Prolanta is a nearly identical drug and will more than likely be a successful antagonist to PRL.
Successful antagonism of PRL doesn't guarantee antitumor activity as a monotherapy, but knowing PRL's role in cancer patients resistance to chemo, it's almost guaranteed to improve the efficacy of the chemo, which would be a major breakthrough.
What we do know, based on what Redman has said and also what Lisa Johnson told me over the phone when I called GHS/ITOR, is that Prolanta, as a monotherapy, is showing efficacy.
Where is a clinical stage drug startup company going to get income from? They aren't in any different of a position than the 100's of Nasdaq biopharma's who are clinical stage. At this point, all these companies have are costs and no way to generate revenue until they can gain an FDA approval and bring a drug to market. The cost manufacturing drugs and clinical trials is in the millions. What are they supposed to do?
There is nothing out of the ordinary with Oncolix.
What's sad about a company raising money in order to continue their phase I trials for women who have late stage ovarian cancer? How else are they going to get money to continue operations? I have yet to hear one person come up with a better alternative.
Should they just scrap the 18+ years of research and development on a promising cancer treatment because of some unfavorable financing? Seriously, what should they have done differently?
*EXCITING PROLANTA SCIENCE*
Wen Chen (Prolanta Inventor)
He also invented Somavert which is known as G120R. Somavert was successfully brought through trials obtaining FDA approval and is now sold on the market by Pfizer. Somavert (G120R) is a growth hormone receptor antagonist. This drug was able to successfully inhibit growth hormone receptors to help patients who have growth hormone disorders.
Prolanta also known as G129R is Wen Chens other invention. He developed both G120R and G129R around the same time period using the exact same amino acid substitution method. These drugs are almost identical to each other. The other interesting fact is that the structure of prolactin is similar to that of growth hormone and placental lactogen.
So here you have 2 identical drugs that are antagonists for 2 hormones that are very structurally similar to each other. Inhibiting human prolactin may be effective in antitumor activity because of its role in the presence and growth of cancerous tumors. The other issue with human prolactin hormones is that they also contribute to humans becoming resistant to chemotherapy. If you can antagonize the human prolactin receptors and hormone, you can at the very least increase the efficacy of chemotherapy, which in itself would be a major breakthrough.
So in conclusion, knowing that we have 2 almost identical drugs working to antagonize structurally similar hormones, we can hypothesize that both would be almost equally effective. One drug, Somavert, has already achieved FDA approval, and the other drug, Prolanta, has a strong probability to follow suit.
Here's an article that contains information regarding the similarities of the prolactin hormone and growth hormone:
https://link.springer.com/chapter/10.1007%2F978-1-4757-3600-7_7
They are both pituitary hormones with structural similarities. Somavert was able to become a successful antagonist to HGH and Prolanta is a nearly identical drug and will more than likely be a successful antagonist to PRL.
Successful antagonism of PRL doesn't guarantee antitumor activity as a monotherapy, but knowing PRL's role in cancer patients resistance to chemo, it's almost guaranteed to improve the efficacy of the chemo, which would be a major breakthrough.
What we do know, based on what Redman has said and also what Lisa Johnson told me over the phone when I called GHS/ITOR, is that Prolanta, as a monotherapy, is showing efficacy.
IMO
I've never once felt ticker change would be a major catalyst. I've always felt it would help to bring some new eyes here, but more importantly it's a key milestone that signifies the successful completion of the merger. 90% of OTC mergers never come to fruition.
Also, it's nice to have something that is consistent. New investors doing surface level DD see a petroleum company making cancer drugs and there's no way they are going to put their money here. At least everything looks legit now.
I've always felt the true catalysts are going to be in the trial updates assuming they will yield positive results. I've had a personal date of around March/April 2018 that's been in my mind since about the mid summer. That's when I think we will see everything come together.