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gestalt2- I appreciate your thoughts. I am also baffled with the FDA. 4 years folks on Pro 140 with no failures...only to want more from CYDY. This definitely makes a long term shareholder question what's going on. I did like Nader explaining the increase dosage from a Dr within the trials telling him there were no injection site side effects and c'mon increase it.
An investigation columnist could really write a good one on behalf of HIV patients not fairing well on available meds while this tic tocs in the FDA's hands. As for Nader, his comment of being on the goal line was tough to wrap around till Pestell used end zone.
IMO- GVHD, I would shelve it also. Save the money. Part of the BO package. Let the buyer pursue the opportunity to develop. Core assets are HIV and now Oncology with it in a few weeks. That's the package.
Chump
nt2innovate- Agree. Nader lit the flame for CYDY years ago. Can't turn my back on him. The new players seem to understand his value also, otherwise never would've come aboard. Things should pick up until closing then speed up afterwards.
Chump
gestalt2-didn't Nader say in the CC non dilutive funding options were close to the table?
Chump
Correct me if I'm wrong. I'm not in the med field. If CYDY partners with Viiv, Merck, Pfizer, Glaxo, Gilead etc. all of the concerns mentioned here about new trial delays.... might change and Pro 140 to existing patients increase in large numbers and actually accelerate a trial. All of these BP's have the trial patient count available to fill a trial overnight. On a stretch maybe even force FDA on "right to try" due to the fatality rate and inhumane to placebo patients through new lengthily trials with oncology and HIV.
FWIW- I would bet on closer to .70's next week vs .40's. Why? I think our semi low vol stock felt some traders take a little profit last week. A small profit takes us down a bunch. Nervous to be left out will let the SP rest and make a corrected move up.
Chump
Follow a couple name drops from CC. Merck, Viiv, Glaxo along with "partnering potential" being mentioned and it's clear why upping the dose to achieve +90% HIV success is clear. And throw in Pestells take on current chemo-combo meds failures.
Maraviroc, Keytruda, Selzentry (all from these companies for oncology and HIV) have serious side effects, liver, hormone gland,organ failures etc. Their success rate not close to Pro-140 trials now at 70% with NO SIDE EFFECTS. But they are making tons of cash now.
I don't see Pro 140 as a threat to them but an opportunity once CYDY closes their deal and secures both oncology and HIV use of Pro 140 under one roof.
CYDY's Pro-140 for HIV and Pestells oncology patents and potential Pro 140 oncology applications are in limbo pending the acquisition close.
My point is after acquisition closing... Pro-140 for HIV or oncology makes them a bigger market target for partnership or buy out.
Just a few weeks!
Chump
Fair enough!
I expect an apology from SA. And pop!
Chump
I heard nothing negative medicine wise. As for financing, (some here crack me up) this latest raise will provide ops funding leading up to and for acquisition closing. Any non dilutive financing will be after the acquisition. No major will step in during a pending closing. How could they? Here's 50 mill, hope you guys close???
Too many concentrating on the days price. I choose to look down the road.
Something about Pro-140 bringing in house great medical and financial minds.
I think some that follow SA articles or bloggers just got kicked.
Chump
Sorry for those that sold at .61 today but happy for the buyers.
Chump
The best to those in the Carolinas. Doesn't look good.
Chump
I support Dr P. My one vote.
Chump
buckysherm- I don't know. Misiu might.
Chump
CytoDyn Announces Plan to Develop PRO 140 for Metastatic Triple-Negative Breast Cancer as Initial Oncology Indication
Download PDF
VANCOUVER, Washington, Sept. 05, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces its plan to develop PRO 140 (leronlimab) as a therapy for triple-negative breast cancer that has metastasized as its initial cancer indication. Previously announced findings from preclinical studies showed the ability of PRO 140 to block human breast cancer cellular invasion in a surrogate assay for metastatic breast cancer.
“Triple-negative breast cells test negative for estrogen receptors (ER-), progesterone receptors (PR-) and HER2 (HER2-) and thus do not respond to hormonal therapy or therapies that target HER2 receptors. Women with this breast cancer subtype typically have a very poor prognosis and new therapies are needed,” said Richard G. Pestell, Ph.D., M.D., Interim Chief Medical Officer of CytoDyn. “Our findings indicate that CCR5 is a crucial receptor in the growth and invasiveness of human malignancies and CCR5 antagonists such as PRO 140 may play a vital role in inhibiting cancer cell invasion and metastasis. PRO 140 may offer an important new therapy for women with metastatic triple-negative breast cancer who have limited therapeutic options.”
“We plan to aggressively pursue the development of PRO 140 as a therapy for women with metastatic triple-negative breast cancer, which is in keeping with our strategy to evaluate PRO 140 in certain cancers and immunological indications where CCR5 antagonism has shown initial promise,” said Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer. “In addition, we are continuing to move forward with plans to assess PRO 140 in metastatic colon cancer and remain committed to concurrently advancing our clinical programs with PRO 140 in human immunodeficiency virus (HIV) and graft-versus-host disease (GvHD). We are pleased with our recent progress toward filing a Biologics License Application (BLA) for PRO 140 as a combination therapy for HIV and are confident that two thirds of our BLA submission will be completed by the end of 2018 and the last section, Chemistry, Manufacturing and Controls (CMC), by first quarter of 2019.”
About PRO 140
PRO 140 is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.
In the setting of HIV/AIDS, PRO 140 belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. At the same time, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 plays a central role in tumor invasion and metastasis and that an increased CCR5 is an indicator of disease status in several cancers. Moreover, researchers have shown that drugs that block CCR5, can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with PRO 140 in the cancer setting and plans to initiate Phase 2 human clinical trials when appropriate.
The CCR5 receptor also plays a central role in modulating immune cell trafficking to sites of inflammation and it is crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others have shown that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with PRO 140 to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD).
About CytoDyn
CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in Phase 3 development. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.
penniestodollars- Thank you!
Chump
A small raise for a bigger reason.
Chump
gestalt2- only an expression for when ones (posting) personality shows itself.
Gonna be a wet night in NOLA. The music never stops. Time to get over .70 again and ride.
Chump
I do believe there are squirrels in the attic.
Chum
lottowomanallday- see u at $1. Welcome here!
Chump
gestalt2- a baby from Phize and GSK. Wanting to grow fast.
https://www.viivhealthcare.com/about-us/who-we-are.aspx
Chump
gestalt2- good post but 5, ViiV. Already on CYDY's porch having tea.
Chump
Got the private email and Thank You! My adviser, my own a** is all in for Pro 140 in multiple prescripts. Patients have patience.
Chump
finesand- I agree, your team is divided. Maybe a core value meeting on multiple aliases should be planned. Plus, throw in unscrupulous requests.
Let us know when CYDY takes your call.
Chump
finesand- precisely my point..... "chump- not that I would ever expect any debate and insight with you here. I only can assume the opinion about the lack of a HIV suitor as described is stepping on your toes. But that is the obvious here. Therefor cancer expansion is the new drive.
Your haughtiness doesn't affect me. Especially after you posted requesting for a NDA signer to post NDA info on IHUB. That in itself is illegal. Add to your blog how you request info.
Chump
finesand- y'all say, "CYDY's cancer expansion should IMHO been seen as something very positive, expanding the expected revenues w/o flattening or even pulling down the curve.
This expansion would potentially scare away any potential HIV only buyer, but we know that there are none. Otherwise there would have been a tender offer long time ago. Whatever their reasons are.
So the expansion should not knock out the buyout in our view, but give it another drive - even though overall valuation will be higher and the BO timeline pushed out."
Insensible conclusion that wreaks of immaturity with terms of capitalization.
Pump your other losing stocks and blog to another theater.
Chump
nt2innovate- glad your posting. You contribute and is appreciative.
Chump
Amatuer17 Here is why many will pass on it. Nothing new. "Delstrigo could worsen symptoms of hepatitis B". Nothing new for the patient with what's available. Have you read any PRO140 precautionary statements of liver failure?
Chump
JPValas- Before sir and just enough!
Chump
JPValas- hell yes!!
Chump
EvilRbt- my knuckles are white on my shares also. Like riding my bike for the first time.
Chump
JPValas- the favorable shareholder financing will be the starting gun. Hold on if your able. As I posted before the new board member has skin in the game and a tremendous reach of contacts for funding other than himself. He will earn his spot on the board with shareholder preferred financing.
Chump
I do not know any particulars but would find it hard to believe our new board member would join CYDY and support again, unhealthy financial terms for the company, short term, given his financial contacts. SP is in his best interest now. I'm willing to let it play out and see who new is brought to the table.
Chump
finesand- I find no clarity in Emergycy's posts or your blog. Take 01 to McDonalds.
Chump
JPValas- A good question. Yes, I think it is complete and favorable to CYDY shareholders. The delay... several/many have to sign off on and time consuming. I thought last tues-wed. In the meantime CYDY has to pay bills.
Many are still under NDA. These .50's will be gone soon.
Chump
coldterdinvestor- beg to differ. The "market" is not in yet,... only retailers like you and why we stay at these levels. CYDY is very aware of insti constraints investing and will adjust for the masses. Hopefully you will wake up and read about it.
Chump
Dolph- hopefully .60 breaks today. Any idea next stop. And thanks!
Chump
RollingWithTheFDA- This can only be done on your share level. Any rec's for non traders?
Chump
finesand- Yes, this approach might be a better way to promote your blog than your numbers. Good gracious!
Chump
EvilRbt- thank you. A good one!
finesand- so do I agree with your first sentence or last? You have free blogspot press here now for whatever valuation beliefs you and zero <01> agree. Just feel you popped in and took it upon yourself to qualify everything here for us, and expect a following. Never been a follower. Your math is flawed..... Too much embroidery.
Chump
Dolph- I say tater. Closing above .56 today mean anything? Seems were getting that EOD walk down.
BTW- A few here need to take the Rorschach test. Gracious!
Thanks
Chump