Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It may be from the Washington “ComPost” but it corroborates what he said he heard in Germany...
I would hardly call that a battle...lol
Obviously you didn’t read all my post.
If posting the link and a copied text of what relates to CYDY was not enough clarification then I don’t know what is.
Anyway I have nothing more to say on this topic.
That’s one of the reason people don’t contribute to this board...
Thanks for defending me. Him making assumptions is one of the reason people shy away from this board.
EP you wrote: “I’ll go on a limb and say that this is the same source of fake news as the earlier one today. We seem to be getting someone’s attention. And that encourages me!”
My response: While I agree that this news is not a big deal, it is NOT fake news. My source of info is from Merryll Lynch and before I posted it I checked the SEC site to confirm.
https://www.sec.gov/news/press-release/2019-6
Everyone is making such a big deal of such a minor infraction, it happens all the time and like Misiu said they corrected it.
Next time I will adhere to the strict terms of this Board’s “Only Positive News Please” rule.
Thanks Misiu. The news came in my inbox through my brokerage account and I posted it. For him to question my intent or imply that there may be a nefarious reason behind me posting it is just ignorant. I had no idea that only positive news are welcome on this board. This is not old news it is something that come out today!
Doesn’t make sense... but ok.
If you are implying that my reason for posting this “non-sense” is for a lower price you are dead wrong. The board is here to post all news - good, bad or “non-sense”
https://www.sec.gov/news/press-release/2019-6
CytoDyn Inc. disclosed material weaknesses in each of its Forms 10-K over a period of nine years, from 2008 through 2016. CytoDyn included in its public filings the same, nearly boilerplate, disclosure of material weaknesses for nine consecutive years. CytoDyn remediated its material weaknesses and determined that ICFR was effective as of May 31, 2017. The Commission’s settled order includes violations of Exchange Act Section 13(b)(2)(B) and Rule 13a-15(a), thereunder, and payment of a $35,000 civil penalty
Back to News
SEC: Companies Disclosed Material Weaknesses and 'Took Months, or Years' to Remdiate Them After Being Contacted by SEC Staff
January 29, 2019
03:13 PM ETPublished January 29, 2019 03:13 PM Eastern TimeDow Jones Newswires
Back to News
SEC: Companies Disclosed Material Weaknesses and 'Took Months, or Years' to Remdiate Them After Being Contacted by SEC Staff
January 29, 2019
03:13 PM ETPublished January 29, 2019 03:13 PM Eastern TimeDow Jones Newswires
News
SEC Announces Charges and Settlements With Group Simec SAB, Lifeway Foods, Digital Turbine Inc., CytoDyn Inc.
January 29, 2019
03:12 PM ETPublished January 29, 2019 03:12 PM Eastern TimeDow Jones Newswires
CytoDyn Signs Definitive Agreement To Acquire ProstaGene; Founder And CEO Dr. Richard Pestell To Join CytoDyn As Interim Chief Medical Officer >CYDY
CytoDyn Announces Strong Preclinical Results Using PRO 140 in Human Colon Carcinoma
CytoDyn will file an IND, along with a proof-of-concept protocol for colon cancer
PRO 140 shown effective in inhibiting human colon carcinoma growth
VANCOUVER, Washington, Aug. 15, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces that PRO 140 (leronlimab) has been shown effective at inhibiting the growth of a human colon carcinoma cell line (SW480) in a prominent mouse model. The results were statistically significant and provide the basis for filing an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial in colon carcinoma patients.
Two different strains of immunoincompetent mice were used to grow SW480 human tumor cells and different doses of PRO 140 were used in these studies. The SW480 cell line was derived from a patient with colon adenocarcinoma and, like many human cancers, was CCR5-positive. PRO 140 extended the life of treated mice and decreased tumor growth compared to control mice by greater than 50%, which was statistically significant. These results were dose dependent and were repeated in separate experiments. Current ongoing preclinical studies are defining the mechanisms involved in the anti-tumor efficacy of PRO 140.
“We have been conducting these preclinical studies over the past year to better document the activity of PRO 140 against CCR5-expressing human tumors,” stated Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “We believe that CCR5 is a crucial receptor in the growth and invasiveness of human malignancies, and these studies support that premise. Along with our recent announcement regarding the potential of PRO 140 in metastatic breast cancer, we believe these results in colon cancer further support that PRO 140, if approved, may offer an important potential therapeutic option for patients with breast and colon cancer. We now plan to file an IND within the next few weeks to begin studies of PRO 140 for the treatment of colon carcinoma. We will also continue to explore the biological pathways involving CCR5 to identify other potential therapeutic opportunities for PRO 140.”
CytoDyn also noted that upon the closing of its proposed acquisition of ProstaGene, Richard G. Pestell, Ph.D., M.D., Chief Executive Officer of ProstaGene and President of the Pennsylvania Cancer and Regenerative Medicine Research Center, is expected to be appointed CytoDyn’s Chief Medical Officer.
“We look forward to Dr. Pestell joining our team and leveraging his decades of research with the CCR5 receptor as we further explore opportunities for PRO 140 in cancer, immunology and autoimmune disorders,” added Dr. Pourhassan.
Back to News
CytoDyn Announces Significantly Improved Response Rate at Higher Dose of PRO 140 in HIV Phase 3 Monotherapy Trial
33 minutes agoGlobeNewswire
Related Investments
Cytodyn Inc
Last 3 Months
Response rate increases from 40% at 350 mg dose to approximately 70% at 525 mg
IRB approves monotherapy protocol modified to include 700 mg dose
PRO 140 monotherapy, if approved, will allow patients to self-administer once per week at home without need for daily pills
VANCOUVER, Washington, July 30, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces clearance from the independent Institutional Review Board (IRB) overseeing its CD03 Phase 3 investigative monotherapy trial to increase the weekly PRO 140 dose from 525 mg to 700 mg for newly enrolled patients. Current participants in the trial who failed to maintain suppressed HIV viral load on a lower dose of PRO 140 will be permitted to continue in the trial with a higher dose. The objective of this trial is to assess the efficacy, safety and tolerability of PRO 140 as a long-acting, single-agent maintenance therapy for the chronic suppression of HIV.
“This IRB decision is exciting for patients, our Company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” said Nader Pourhassan, Ph.D., CytoDyn’s president and chief executive officer. “Approximately 70% of trial participants who started with PRO 140 at the 525 mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even a higher dose.”
Dr. Pourhassan noted that the exact response rates for PRO 140 at 525 mg could vary as the trial progresses. To date, there has been a clear distinction between patient response rates with PRO 140 at the lower 350 mg and higher 525 mg doses. CytoDyn believes that dosing PRO 140 at the 700 mg dose has the potential to achieve an even higher response rate than the approximate 70% currently observed at the 525 mg dose.
“We are able to increase the dose of PRO 140 due to its positive safety profile in prior clinical trials,” Dr. Pourhassan commented. “That was among the important factors considered by the IRB in providing this clearance.”
Patients enrolled in the Phase 3 monotherapy trial were prescreened for CCR5-tropic HIV-1 infection and suppressed HIV viral load under an existing highly active antiretroviral therapy (HAART) regimen. CytoDyn initiated the trial treating patients with weekly PRO 140 at 350 mg and found that approximately 40% were able to maintain suppressed HIV viral load. Following treatment of the first 150 patients, the protocol was revised to increase the weekly dose of PRO 140 to 525 mg. Patients who were non-responders to PRO 140 at the 350 mg dose were given the opportunity to switch to the higher 525 mg dose, and a majority were able to re-suppress with the higher dose.
“We were pleased that more than 20 patients achieved re-suppressed HIV viral load on PRO 140 525 mg dose after failing the lower PRO 140 350 mg dose and were able to continue in the trial,” said Dr. Pourhassan. “Also of note, patients who achieve suppressed HIV viral load after 10 weeks tend to maintain suppressed viral load. Interestingly, some patients in our Phase 2b extension study are now achieving suppressed HIV viral load for nearly four years with PRO 140 as a single agent.”
“Of key importance in the Phase 3 monotherapy trial, all non-responders to PRO 140 have safely achieved suppressed HIV viral load upon returning to their prior HAART regimens before PRO 140 monotherapy,” said Jacob Lalezari, M.D., Director of Quest Clinical Research, Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital and principal investigator of CytoDyn’s Phase 2 monotherapy trial. “This is a major achievement as patients continue to have options for maintaining HIV viral load sup
Seeking Alpha:
Biotech Analysis Central Pharma News: Cytodyn's Acquisition,
https://seekingalpha.com/article/4187330
VANCOUVER, Washington, July 13, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY) announces that management will host an investment community conference call to provide a business update. ?
Press Release :
Results from CytoDyn’s Pivotal PRO 140 Combination Therapy Trial in HIV to be Presented at ASM Microbe 2018 on June 9
VANCOUVER, Washington, June 04, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY) announced today that results from a Phase 2b/3 trial with PRO 140 (humanized CCR5 monoclonal antibody) in heavily treatment-experienced HIV-1 patients will be presented in a Late-Breaker Abstract poster session at ASM Microbe on Saturday, June 9, in Atlanta. The trial results detail data from the one-week, single-dose, randomized, double-blind, placebo-controlled portion of the pivotal trial of PRO140 in combination with optimized background anti-retroviral therapy (ART).
Session 226: Late Breaker Abstract poster session
Title: “Primary Efficacy Results of PRO 140 SC in a Pivotal Phase 2b/3 Study in Heavily Treatment-Experienced HIV-1 Patients”
Date: Saturday June 9
Time: 11:00 am - 1:00 pm ET
Location: Exhibit and Poster Hall, Building B, Halls B2-B5
Georgia World Congress Center
Control/Tracking Number: 2018-LB-7818-MICROBE
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is intended to protect healthy cells from viral infection. PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. 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 FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). 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.
CytoDyn Inc, Inst Holders, 1Q 2018 (CYDY)
April 20, 2018 3:35 AM ET | Dow Jones Newswires
The following table shows the largest shareholders in CYTODYN INC COM (CYDY) for the quarter ended March 31, 2018, listed by holding size. The list represents up to 50 of the largest holders in the company.
Note: Unless otherwise mentioned the reporting date is 03/31/2018
Institution Shares Shares % Last
Held Changed Held Report
Diversified Trust Co. 225,500 0 0.108 12/31
Inverness Counsel LLC 15,000 0 0.007 12/31
13F data provided by: Factset Research Systems Inc.;
Please send questions to ownership@factset.com.
Copyright, Factset Research Systems, 2018. All Rights Reserved.
(END) Dow Jones Newswires
April 20, 201803:35 ET (07:35 GMT)
CytoDyn Forms Scientific Advisory Board to Advance PRO 140 Development in Immunological Disorders
Download PDF
NEW ADVISORS INCLUDE LEADERS IN IMMUNOLOGY, ONCOLOGY AND DRUG DEVELOPMENT
VANCOUVER, Washington, March 29, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY) announces the formation of a Scientific Advisory Board to advise on the development of PRO 140 in certain immunologic disorders. PRO 140 is a humanized monoclonal antibody under development by CytoDyn that targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of certain inflammatory conditions.
“It is a privilege to assemble this group of prominent authorities in immunology, oncology and drug development to advise on the development of PRO 140 in immunologic disorders,” said Denis R. Burger, Ph.D., Chief Science Officer of CytoDyn. “PRO 140 has potential applications in cancer progression, transplantation rejection, autoimmunity, and chronic inflammation. Based on the strength of preclinical and clinical study data combined with human safety and efficacy data from our HIV program, we believe PRO 140 warrants further development across a range of immunological indications.”
Members of CytoDyn’s Scientific Advisory Board are as follows:
David Hinrichs, Ph.D., is a research scientist at the Veterans Administration Medical Center in Portland, Oregon and Professor of Molecular Microbiology and Immunology at Oregon Health & Science University (OHSU). He received a B.S. in Biology from Mankato State and Ph.D. in Microbiology and Immunology from the University of Arizona.
Patrick Iversen, Ph.D., is adjunct professor at Oregon State University and scientific founder and Chief Science Officer of LS Pharma, LLC., a biopharmaceutical company focused on the discovery and development of novel RNA-based therapeutics. Dr. Iversen earned a B.S. degree from Westminster College and Ph.D. in Biochemical Pharmacology and Toxicology from the University of Utah School of Medicine.
Daniel Lindner, MD, Ph.D., is Director of Animal Tumor Core of the Taussig Cancer Institute at the Cleveland Clinic. He received a BS in biology from MIT, medical degree from Georgetown University, Ph.D. in microbiology from the Medical College of Wisconsin.
Richard Pestell, MD, Ph.D., MB.BS, FRACP, FACP, FAAAS, MBA, FRS of Medicine, is President of the Pennsylvania Cancer and Regenerative Medicine Research Center and Distinguished Professor at the Baruch S. Blumberg Institute. He received a medical degree from the University of Western Australia, Ph.D. from the University of Melbourne and conducted postdoctoral research at the Harvard School of Medicine and Massachusetts General Hospital. He received his executive MBA from New York University Stern School of Business.
David L. Porter, MD, is the Jodi Fisher Horowitz Professor of Leukemia Care Excellence and Director of Cell Therapy and Transplantation at the University of Pennsylvania. He received his medical degree from Warren Alpert Medical School of Brown University.
Jonah Sacha, Ph.D., is associate professor at OHSU and has appointments in the Vaccine & Gene Therapy Institute and Oregon National Primate Research Center. He received his Ph.D. in Medical Microbiology & Immunology from the University of Wisconsin-Madison and B.S. in Biology from the University of Missouri-Columbia.
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is intended to protect healthy cells from viral infection. PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of eight 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 FDA also granted orphan drug designation to PRO 140 for the prevention of graft-versus-host disease (GvHD). 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.
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 eight 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.
Gilead's GS-9620 + neutralizing Ab show encouraging action in preclinical HIV eradication study
Mar. 5, 2018 6:44 AM • SA Editor Douglas W. House
Results from a preclinical proof-of-concept study evaluating the combination of Gilead Sciences' (NASDAQ:GILD) GS-9620, an oral toll-like receptor 7 (TLR7) agonist and PGT121, a proprietary investigational broadly neutralizing antibody, showed a positive effect in eradicating simian-human immunodeficiency virus (SHIV) in non-human primates on suppressive antiretroviral therapy (ART). The data were presented at the Conference on Retroviruses and Opportunistic Infection in Boston.
The study involved 44 SHIV-infected rhesus monkeys who started ART on day 7 post-infection. After 96 weeks of continuous ART, they were divided into four equal groups who received either five doses of PCT121 every two weeks for 10 weeks, 10 doses of GS-9620 every two weeks for 20 weeks, placebo or both PCT121 + GS-9620.
After ART discontinuation, five of the 11 animals receiving the combination showed no viral rebound for at least 168 days. The other six rebounded but then began re-suppressing the virus without ART.
Almost all of the primates in the other three groups experienced viral rebound.
The research, conducted with researchers at Beth Israel Deaconess Medical Center, was supported by the Bill & Melinda Gates Foundation.
Seeking Alpha
FDA OKs TaiMed's HIV med ibalizumab http://www.seekingalpha.com/news/3336851
• The FDA approves privately held TaiMed Biologics' Trogarzo (ibalizumab-ulyk) for the treatment of adults with chronic HIV infection who have not responded adequately to other treatments.
• Ibalizumab, a humanized monoclonal antibody, is administered intravenously once every 14 days and is used with other antiretroviral medications.
• In a clinical trial involving 40 heavily pretreated patients with multidrug-resistant HIV-1 infection who continued to have high levels of virus in their blood despite antiretroviral therapy (most had received 10 or more antiretroviral drugs), 43% achieved HIV RNA suppression after 24 weeks of Trogarzo.
• On the safety front, the most common adverse events were diarrhea, dizziness, nausea and rash. Severe adverse events included rash and immune reconstitution syndrome, a condition in some HIV patients where the immune system recovers but then responds to a previously acquired opportunistic infection with an overwhelming immune (inflammatory) response.
No.
CytoDyn Makes Huge Stride For HIV Patients, Now Acts As A Potential Acquisition Target $CYDY
https://seekingalpha.com/article/4148807
SEC Filing Alert
4: Statement of changes in beneficial ownership of securities
https://ir.cytodyn.com/all-sec-filings/content/0000899243-18-002767/form4.html
4: Statement of changes in beneficial ownership of securities
https://ir.cytodyn.com/all-sec-filings/content/0000899243-18-002768/form4.html
4: Statement of changes in beneficial ownership of securities
https://ir.cytodyn.com/all-sec-filings/content/0000899243-18-002769/form4.html
Harsh but true!
Wow...this comment is totally inappropriate.
SEC Filing Alert for CytoDyn Inc.
The following documents have been filed with the SEC:
SEC Filing Alert
8-K: Current report filing
HTML PDF
SC TO-I/A: Issuer tender offer statement
https://ir.cytodyn.com/all-sec-filings/content/0001193125-17-352470/d439955d8k.htm
Cytodyn Is Worth A Look Before Phase 3 HIV Data
Nov. 20, 2017 11:33 AM • CYDY
Summary
Upcoming phase 3 combination data of Pro-140 with optimized background therapy could change the landscape of HIV treatment.
Pro-140 has shown to be safe with fewer side effects, and has shown to suppress viral load in a lot of patients for over 2 years as a monotherapy.
Gilead has a combo regimen of its own for one pill per day, but still remains with a lot of side effects.
A new treatment option is desperately needed for patients on ART therapy, because of side effects.
CytoDyn may need to raise additional cash in the coming months to support its clinical development and potential BLA filing of Pro-140 pending positive phase 3 combination data.
CytoDyn (OTCQB:CYDY) is expected to release its interim phase 3 data in the coming weeks. That presents a good opportunity for those looking to invest in a highly promising biotechnology company. According to the company's conference call back on October 19th, the data would be forthcoming from 4 to 6 weeks from that date. That means that there should be an interim look into the efficacy of the phase 3 trial treating HIV patients using Pro-140 within the next few weeks.
Phase 3 Trial
The phase 3 trial is testing Pro-140 in combination with optimized background therapy in treatment-experienced HIV-1 patients. These patients must have the CCR5 tropic version of HIV. The trial is recruiting a total of 50 patients in which it will evaluate if the primary endpoint has been met. Enrollment is not complete, but the FDA stated that it would allow the company the opportunity to perform an interim analysis on the first 40 patients to determine if the primary endpoint has been met. That means that data from the other 10 patients will come a month or later thereafter. The most important item to consider now is whether or not the phase 3 primary endpoint is achieved. The primary endpoint is looking for a proportion of patients who achieve a ≥ 0.5 log10 reduction in HIV-1 RNA viral load from baseline at the end of 1 week of treatment with Pro-140 in combination with background therapy. This trial is testing Pro-140 as a combination therapy. The hope is that such a combination treatment will reduce the need for a patient to remain on single ART therapy alone. I believe that Pro-140 has a good chance at success for reasons that I will describe below.
Prior Data
Why I think the phase 3 trial stands at a good chance for success is because of the progress of the patients in the phase 2b extension study. It was shown that weekly treatment with Pro 140 SC mg suppressed HIV-1 RNA levels below 40 copies/mL for > 40 weeks in 81.3% of patients (13 out of 16) and for > 2 years in 62.5% of patients (10 out of 16). Remember, this phase 2b extension study is for Pro-140 as a single agent therapy (no combination added). The phase 3 trial noted above is for Pro-140 in combination with optimized background therapy. That means that the combination therapy, in theory, should be substantially superior. Then again, the results from the phase 2b monotherapy of Pro-140 also support development for approval. That is why CytoDyn is also running another phase 3 study with Pro-140 being given as a monotherapy only. The downside is that the phase 3 monotherapy study has to recruit up to 300 patients. For now, the key is to see if Pro-140 in combination with optimized background therapy meets on the primary endpoint. The upcoming phase 3 results will be key to the success of CytoDyn.
New Treatment
The best part about Pro-140 is that it is given as a once a week self injectable treatment at home. Think of these HIV patients right now, that have to take pills everyday for the rest of their lives to keep their viral load suppressed. Even then, ART therapy has severe toxicity and side effects. That makes treatment with ART barely tolerable for patietns to take. On the other hand, Pro-140 has negligible toxicity, and no serious side effects/serious adverse events observed in over 200 patients treated across 7 different clinical trials.
Advertisement
Competitor
The current big competitor is Gilead (GILD). This company is working on combo therapies in order to improve the HIV treatment landscape itself. It has seen some amazing results in terms of efficacy, but it still has one major problem. The combo treatment has a lot of side effects. The combo treatment from this big pharma may not have serious adverse events, but it has a lot of side effects. For example, Bictegravir alone has nausea and diarrhea as side effects. When I looked up tenofovir alafenamide some side effects shown were: Diarrhea, upper respiratory tract infection, fatigue, nausea, and rash. Looking up Emtricitabine I found that some side effects include: Tiredness, trouble breathing, stomach pain with nausea and vomiting, dizziness and several others. This compares to Pro-140 which is a monoclonal antibody that has no side effects at all. I would think that a patient with HIV would prefer one injectable shot of Pro-140 per week as opposed to having to take a single pill everyday. In addition, I would be inclined to believe that a patient would prefer treatment that is free of the side effects I noted above.
Market Opportunity
CytoDyn has listed the combination therapy with Pro-140, which is set to report the phase 3 study in a few weeks, as being a $5 billion dollar market opportunity. That leaves the monotherapy potential of Pro-140 as an $11 billion market opportunity. I think that Pro-140 has a good chance at success. For starters, all the data shown to date has shown that the treatment reduces viral load below 40 copies/mL. There are at least 9 patients that have completed 2.5 years with Pro-140 as a monotherapy alone. This Pro-140 drug was acquired from Progenics (PGNX), therefore CytoDyn has to pay it a 5% royalty on net sales according to the agreement made should Pro-140 be approved by the FDA. If the phase 3 results are good and CytoDyn hits the primary endpoint then I am expecting Gilead Sciences to either partner with the company or buy it out. Gilead has been doing okay, but has had recent troubles with its Hepatitis C franchise. I doubt that Gilead will allow a small company like CytoDyn to enter its turf without doing something about it. It could leave the small-cap biotech alone, but if it does that will likely cripple sales for Gilead in its HIV franchise. Which is why I expect a high chance of a buyout of CytoDyn should it meet the primary endpoint of the phase 3 combination study.
Financials
The problem with CytoDyn is that it is a small-cap biotech stock that trades on the OTC. It has limited cash, and therefore is a huge risk of possible dilution occurring after positive phase 3 data (should the results be positive). According to the most recent 10-Q SEC filing, the company had ended August 31, 2017 with cash of $0.9 million. As I have stated if the results are good, then it is possible to expect some type of cash raise. Although, on the other hand with good data the company could also easily seek out a big pharma partner to foot the bill thereafter. The main point now is it highly depends on the upcoming phase 3 results on what will happen for the company in terms of its financials and its future.
Risks
Of course, the first risk is the dilution I noted above as CytoDyn is low on cash. The bigger risk would be whether or not the phase 3 data will succeed. I have high hopes that the trial will meet the primary endpoint of the study. The risk is that the prior trials were done with a small group of patients, therefore there is a chance that the phase 3 trial may not succeed. That is a risk to keep in mind. Still, I like the risk/reward scenario a lot because if it does succeed then the stock price will gap higher in the short-term. Another risk is that the company is thinking of enacting a reverse stock split to uplist to a higher stock exchange, and move away from the OTC. If that happens then it is possible for shares of investors to be reduced greatly.
Conclusion
I have high hopes that CytoDyn should succeed in its combination phase 3 study. If anything, patients need Pro-140 as a new treatment option. Not only is compliance with an injection better, one treatment per week, but it has less side effects. If this company succeeds then it will change the landscape for HIV treatment and I believe that's worth the risk/reward scenario. If the trial fails I expect the stock to tumble down to $0.25 to $30 cents per share. If it succeeds I can see it heading to $1.20 to $1.50 per share in the short-term.
Author's note: To get these types of premium articles on attractive biotech and pharma stocks as soon as they are published, just click here for my profile. Hit the big orange "Follow" button and choose the real-time alerts option thank you for taking the time to read my analysis.
Terry Chrisomalis runs the Biotech Analysis Central pharmaceutical investment research service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to my service, I'm currently offering a two-week free trial period for subscribers to take advantage of. Only the first 25 subscribers will get the lower legacy rate. If you want to secure your spot, please do so as soon as possible.
Disclosure: I am/we are long CYDY.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
CytoDyn’s PRO 140 Monoclonal Antibody Prevents Graft-Versus-Host Disease in Model of Bone Marrow Stem Cell Transplantation
Download PDF
PRO 140 Currently in Phase 2 Clinical Trial in Leukemia Patients Receiving Bone Marrow Transplants
Preclinical Proof-of-Concept Published in Biology of Blood and Marrow Transplantation
VANCOUVER, Washington, Nov. 14, 2017 (GLOBE NEWSWIRE) -- Newly published research provides preclinical proof-of-concept for the ability of PRO 140, a humanized anti-CCR5 monoclonal antibody under development by CytoDyn Inc. (OTC.QB:CYDY), to effectively block the development of graft-versus-host disease (GvHD), a potentially lethal complication of bone marrow stem cell (BMSC) transplantation. CytoDyn is currently enrolling patients in a Phase 2 clinical trial with PRO 140 for the prevention of GvHD in leukemia patients undergoing BMSC transplantation.
The new publication shows that when immunocompromised mice transplanted with human BMSCs received PRO 140 at a dosing schedule that approximates that being used in the ongoing human clinical trial, the mice showed successful engraftment of human hematopoietic (blood forming) cells without any signs of GvHD. At the same time, control mice all exhibited classical signs of GvHD and none survived (p?0.01). A 10-fold reduction in PRO 140 dose still showed a significant inhibitory effect on GvHD in treated mice, but to a lesser extent.
The study (click on link) by Denis R. Burger, Ph.D., CytoDyn Chief Science Officer, and Daniel Lindner, M.D., Ph.D. of the Department of Translational Hematology and Oncology Research, The Cleveland Clinic, has been published online in the peer-reviewed journal, Biology of Blood and Marrow Transplantation. (Also see: http://www.bbmt.org/article/S1083-8791(17)30810-8/fulltext)
“This research provided CytoDyn with strong rationale for exploring the use of PRO 140 in its second clinical indication, the prevention of GvHD in BMSC transplantation, following our focus on the treatment of HIV infection,” said Dr. Burger. “GvHD is a serious complication that limits the use of BMSC transplantation in patients with blood cancers. The potential of PRO 140 to prevent this life-threatening condition could help extend the use of BMSC transplantation, an important and effective therapy, to more patients.”
PRO 140 targets the CCR5 receptor, a molecule that modulates the immune cell trafficking crucial for the development of acute GvHD and other inflammatory conditions. Previous 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 BMSCs. This new study with PRO 140 further supports 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.
About GvHD
Graft-versus-host disease is a risk when patients receive bone marrow stem cells donated from another person. GvHD occurs when the donor’s immune cells attack the patient’s normal tissues (skin, liver, gut). GvHD can be acute or chronic. Its severity depends on the differences in tissue type between patient and donor. Acute GvHD can occur soon after the transplanted cells begin to appear in the recipient and can range from mild to severe and can be life-threatening. Certain immunosuppressive drugs may help prevent or lessen GvHD. However, GvHD doesn't always respond to these treatments, and it can still result in fatal outcomes. Furthermore, many deaths related to GvHD occur because of infections that develop in patients whose immune systems are suppressed by such drugs.
SA Breaking News Team
CYDY: CytoDyn receives ODD for PRO 140 for prevention of GvHD
“Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.”
CytoDyn Receives Orphan Drug Designation for PRO 140 for Prevention of Graft Versus Host Disease
VANCOUVER, Washington, Oct. 05, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PRO 140 for the prevention of graft versus host disease (GvHD). Orphan drug designation is granted to development-stage drugs that have shown promise in addressing serious medical needs for patients living with rare conditions. This designation provides CytoDyn with various incentives and benefits including seven years of U.S. market exclusivity for PRO 140 in GvHD, subject to FDA approval for use in this indication.
“GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia who have compromised immune systems due to treatment with aggressive cancer therapies,” said CytoDyn Chief Science Officer Denis R. Burger, Ph.D. “We chose GvHD as the first non-HIV indication for PRO 140 as it targets and masks the CCR5 receptor on T cells. This receptor on T cells is an important mediator of inflammatory diseases including GvHD, especially in organ damage that is the most frequent cause of death in these patients. Prior clinical trials have shown PRO 140 to be safe and well tolerated, with negligible toxicities or side effects.”
Type is PRO 140 to view the status:
https://www.globalclinicaltrialsdata.com/
CytoDyn (OTCQB:CYDY) announces that 34 patients have been enrolled in its Phase 2b/3 clinical trial assessing PRO 140, combined with antiretroviral therapy, in HIV-infected patients. 33 have completed the one-week efficacy endpoint and 11 have completed the full 25-week protocol with undetectable viral loads and 10 of these are currently in the rollover study.
• Target enrollment is 300. Dosing began in Q4 2016.
• The company says it will meet with the FDA on October 17 to discuss next steps "towards the analysis of the primary efficacy endpoint." The primary endpoint is already established (proportion of patients who remain on PRO 140 monotherapy at the end of week 48 without experiencing virologic failure) so it is unclear why a meeting with the FDA is necessary unless it wants to adjust the endpoint.
• The PRO 140 antibody is a viral entry inhibitor that targets the CCR5 (C-C chemokine receptor type 5) co-receptor, a protein on the surface of white blood cells that acts as a receptor for chemokines, signaling proteins that induce chemotaxis (chemical-induced movement) in nearby cells. This is the process by which the immune system's T cells are attracted to specific targets. HIV uses CCR5 to enter and infect host cells.
• PRO 140 will compete against the only other CCR5 antagonist approved for the treatment of HIV infection, ViiV Healthcare's (NYSE:GSK)(NYSE:PFE) (OTCPK:SGIOY) Selzentry (maraviroc). PRO 140's value proposition compared to Selzentry is less toxicity, fewer side effects and once-weekly administration versus daily.
The following documents have been filed with the SEC:
SEC Filing Alert
10-K/A: Annual report pursuant to Section 13 and 15(d)
http://ir.cytodyn.com/all-sec-filings/content/0001193125-17-238701/d421262d10ka.htm
Current Clinical Trials
PRO 140 is currently being studied in four ongoing clinical trials:
• Our first ongoing clinical trial is an extension study of our Phase 2b treatment substitution trial, which was initially completed in January 2015. Several patients are continuing in extension studies of this monotherapy trial by taking a weekly injection of PRO 140. Results from these extension studies thus far indicate that eight of the nine patients in this study have surpassed two and one-half years of suppressed viral load through a successful monotherapy of PRO 140 and are approaching three years of suppressed viral load with a monotherapy.
• Our second ongoing clinical trial is a pivotal Phase 2b/3 trial for PRO 140 as a combination therapy with existing HAART drug regimens. The initial 25-week trial protocol included a requirement for 300 patients. The FDA reduced this requirement to 150 patients and finally down to 30 patients. The primary endpoint for efficacy is defined as the amount of viral load drop after one week of therapy with PRO 140 in combination with the patient’s failing HAART regimen. Patient enrollment is expected to be completed in July 2017 and we will announce whether the trial has achieved its primary endpoint as soon as that determination is available. The first patients to have successfully completed this trial have transitioned into a FDA-cleared rollover study, in order to provide continued access to PRO 140 therapy, at the request of their treating physician.
• Our third ongoing trial is an investigative Phase 2b/3 trial featuring 300 patients to assess the treatment strategy of using PRO 140 subcutaneously as a long-acting single-agent maintenance therapy for 48 weeks in patients with suppressed viral load with CCR5-tropic HIV-1 infection. The primary endpoint is to assess the clinical safety of the PRO 140 monotherapy regimen and to evaluate the proportion of participants experiencing suppressed viral load. The secondary endpoint is the length of time to virologic failure. The first patients were enrolled in December 2016, and we expect enrollment to be completed by the end of calendar 2017.
• Our fourth ongoing trial of PRO 140 is a Phase 2 study for Graft-versus-Host Disease (“GvHD”) and is the first non-HIV immunologic indication for PRO 140. This trial, a randomized, double-blind, placebo-controlled, multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) undergoing allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient was announced in May 2017.
CytoDyn Inc, Inst Holders, 2Q 2017 (CYDY)
July 20, 2017
03:47 AM ETDow Jones Newswires
Related Investments
CytoDyn Inc
Last 3 Months
The following table shows the largest shareholders in CYTODYN INC COM (CYDY) for the quarter ended June 30, 2017, listed by holding size. The list represents up to 50 of the largest holders in the company.
Note: Unless otherwise mentioned the reporting date is 06/30/2017
Institution
Diversified Trust Co.
Shares:225,500 $0.151 03/31
13F data provided by: Factset Research Systems Inc.;
Please send questions to ownership@factset.com.
Copyright, Factset Research Systems, 2017. All Rights Reserved.
(END) Dow Jones Newswires
July 20, 201703:47 ET (07:47 GMT)
Back to News