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CytoDyn requests "end Phase 2b meeting" with FDA to discuss Phase 3 plans
CytoDyn Announces 100% Success With PRO 140 in Four-Week Monotherapy Clinical Trial
http://ir.cytodyn.com/press-releases/detail/184/cytodyn-announces-100-success-with-pro-140-in-four-week
More details tomorrow ...
CytoDyn Investment Community Call to Discuss Interim Results from its Treatment Substitution Study in Patients with HIV
Tuesday, October 14th, 1 pm west coast
http://ir.cytodyn.com/
Currently recruiting participants, Verified October 2014 Drexel University
Primary Outcome Measures:
•• To assess the maximum change in viral load following initiation of different dosing regimens of PRO140 [ Time Frame: 59 days ] [ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
http://clinicaltrials.gov/ct2/show/NCT02257788?term=pro+140&rank=4
Drexel's Jeffery Jacobson Publishes CCR5 Paper This Week
Defining Differential Genetic Signatures in CXCR4- and
the CCR5-Utilizing HIV-1 Co-Linear Sequences
Jacobson among many who authored this report that published Sept 29, 2014
http://www.plosmedicine.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0107389&representation=PDF
Does this mean Jacobson finally has the time to conduct the PRO140 trials that NIH has funded?
http://clinicaltrials.gov/ct2/show/NCT01272258?term=cytodyn&rank=6
$ Raise, New Board Member - New Listing
OTC Markets Group Inc. (OTCQX: OTCM), operator of Open, Transparent and Connected financial marketplaces, today announced CytoDyn, Inc. (OTCQB: CYDY) is verified for trading on OTCQB®, the venture marketplace for entrepreneurial and development stage companies, as of October 2, 2014.
http://www.otcmarkets.com/stock/CYDY/news?id=88911
On September 26, 2014, the Company sold the Note in the principal amount of $2,000,000 to AVCP in a private placement in exchange for
cash in an equal amount. The principal amount of the Note plus unpaid accrued interest is convertible at the election of the holder into shares of
the Company’s common stock at any time prior to maturity at an initial conversion price of $1.00 per share. The conversion price is subject to
(i) adjustment for stock splits and similar corporate events and (ii) reduction to a price per share that is 10% below the lowest sale price that is
below $.9444 per share, for shares of CytoDyn common stock sold in future securities offerings, if any, including sales to AVCP and its
designees. Additional terms of the Note are described under Item 2.03 above, which information is incorporated herein by reference.
As part of the AVC Investment, the Company issued warrants to AVCP to purchase a total of 250,000 shares of the Company’s common
stock exercisable at a price of $0.50 per share. The warrants are currently exercisable in full, include a cashless exercise feature, and will expire
on December 31, 2019.
Under the Subscription Agreement, together with a side letter agreement between the Company and AVCM, AVCM and its designees have
the right, but not the obligation, to invest up to an additional $6.0 million on the same terms as the initial $2.0 million AVC Investment until December 31, 2014 ....
http://ir.cytodyn.com/all-sec-filings
CytoDyn Appoints Carl Dockery to Board of Directors
The Alpha Venture Capital investment limited partnerships managed by Mr. Dockery beneficially own approximately 9.5% of the Company's outstanding common stock, including a recent $2 million investment.
http://www.cytodyn.com/media/press-releases/detail/164/cytodyn-appoints-carl-dockery-to-board-of-directors
The potential to target CCL5/CCR5 in breast cancer
Expert opinion: The role of CCR5 in HIV infection led to the development of specific and potent CCR5 antagonists. The data reviewed here includes basic and translational studies that support the use of such CCR5 antagonists in breast cancer patients as adjuvant therapy to block the metastasis.
Read More: http://informahealthcare.com/doi/abs/10.1517/14728222.2014.949238
Pretty Good Video on CCR5 Antagonists
http://www.disclose.tv/action/viewvideo/186544/CCR5_Antagonist/?utm_medium=facebook&utm_source=twitterfeed
Big Pharma loves buying appealing small caps like CytoDyn, Inc. (NASDAQ: CYDY)
CytoDyn is a small cap biotech firm with a product developing well that could revolutionize the treatment of HIV patients.
That is a huge market with tremendous cost savings from the "drug holiday" treatment that CytoDyn hopes to bring to market. This is type product that, if approved, makes the host company very tempting.
Read more: http://www.benzinga.com/trading-ideas/long-ideas/14/04/4492163/3-ways-to-profit-from-merger-activity-in-the-pharmaceutical-s#ixzz3DRnmEhBn
It was two years ago when ...
CytoDyn Named Dr. Nader Pourhassan New CEO
http://www.cytodyn.com/media/press-releases/detail/28/cytodyn-inc-names-dr-nader-pourhassan-new-ceo-announces
stock price = .85
outstanding shares approx 25 million
http://finance.yahoo.com/q/hp?s=CYDY&a=08&b=8&c=2012&d=08&e=13&f=2014&g=d&z=66&y=462
since then:
major dilution, fired scientific officers, MAJOR dilution
stock price now = .75
outstanding shares approx 100 million
BUT ...
he actually got a trial started (no thx to Drexel) and those results are coming soon
The cash is all gone and D Day approaches fast ...
Nader Legacy: Hero or Zero??????
Yes, VERY frustrating Dr Jacobson won't budge especially seeing that he has been working on other HIV projects ....
http://www.ncbi.nlm.nih.gov/pubmed/?term=jeffrey+jacobson
in 'other news' ....
ALEXANDRIA, Va., Sept. 8 -- CytoDyn, Vancouver, Washington, has been assigned a patent (8,821,877) developed by five co-inventors for methods "for inhibiting HIV-1 replication involving the administration of an anti-CCR5 receptor monoclonal antibody and small molecule CCR5 receptor antagonist."
http://www.4-traders.com/CYTODYN-INC-163210/news/CytoDyn--Assigned-Patent-19009978/
Audio of Dr Jeffrey Jacobson Discussing PRO 140
http://www.audiomedica.com/general-medicine/audio-journal-of-medicine-monoclonal-antibody-to-help-treat-hiv/
Maraviroc is a poor (and toxic) ccr5 antagonist yet still manages to garner annual sales of around a quarter billion dollars so you can imagine what kind of market share a good (and safe) ccr5 would generate.
Johns Hopkins researchers discover that FDA-approved HIV drug may be useful in treating breast cancer metastasis
A combination of maraviroc and an anti-VEGF agent completely eliminated metastasis. In addition, depletion of IL6 in the TCM using an IL6 antibody also resulted in complete inhibition of metastasis.
These preclinical studies suggest that similar treatment might lead to new ways of preventing metastasis and treating metastatic patients. For example, IL6 receptor inhibitor tocilizumab is an FDA-approved anti-inflammatory drug and maraviroc or other CCR5 inhibitors could be administered prior or after surgery, possibly in combination with standard of care therapeutics.
http://www.bme.jhu.edu/news-events/news-highlights.php?id=455
Maraviroc may prevent breast cancer from metastasizing, PRO140?
In the same report, the researchers say maraviroc, a drug already approved for treating HIV infection, blocked the siren call of CCL5 in tests on animals and cells and prevented tumor spread (metastasis). Additional experiments using a combination of maraviroc and a drug that blocks the VEGF protein suggest that the treatment duo could be an effective way to prevent metastatic disease in human breast cancer patients, according to the researchers.
Because the anti-retroviral drug maraviroc has already been approved by the U.S. Food and Drug Administration and has been shown safe for long term, oral use, it could be tested in clinical trials sooner rather than later, says Aleksander Popel, Ph.D., a professor in the Department of Biomedical Engineering at the Johns Hopkins University School of Medicine and member of the Johns Hopkins Kimmel Cancer Center.
Maraviroc is currently the only CCR5 antagonist on the market.
PRO 140, also a CCR5 antagonist, is close to being the 2nd CCR5 antagonist to reach the market as it completes its phase 2b substitution trial. PRO 140 is backed with $8 million in NIH grants and FDAs 'fast track' designation.
Might it serve both the HIV and breast cancer population?
http://medicalxpress.com/news/2014-09-prepped-tumor-cells-lymphatic-breast.html
hey dog - just hopeful we get an update this week being the last came at the annual shareholder meeting stating:
After 4 weeks of monotherapy:There were no virologic failures in the first 12 patients. 100% of the patients passed 4 weeks of monotherapy.
•After 8 weeks of monotherapy:There were no virologic failures in six patients. Six patients had virologic failure and are being retested. Of those, two are confirmed to have Dual-Mix virus. Excluding those two patients, 6 of 10 patients (60%) had viral load suppression after 8 weeks of monotherapy compared to nearly 0% in historical controls.
•After 10 weeks of monotherapy:Five patients have not experienced virologic failure;two have now passed 11 weeks of monotherapy with zero failure. However, an additional patient experienced virologic failure at 10thweek of monotherapy. To date, we have 7 patients with virologic failure, two were ruled out, as they were D/M, the other five are being retested.
In regards to second cohort of 28 patients:Four patients received their first dose of PRO 140, with first patient receiving his/her first dose of PRO 140 on August 4, 2014
Since the above update, I'd like to know about the patients who have completed the substitution trial, the new batch who are starting week 5 and if the other virologic failures were also D/M?
Hoping this week brings more trial results and news of non-diluting fund raising ....
Tomorrow is huge for the future of $CYDY
I'm excited to hear more results from the current treatment substitution trial.
Additional treatment applications for PRO140 beyond HIV?
CCR5 Controls Immune and Metabolic Functions during Toxoplasma gondii Infection.
Altogether, these data demonstrated that CCR5 is essential to the control of T. gondii infection and to maintain the metabolic, hepatic and intestinal integrity. These findings add novel information on the disease pathogenesis and may be relevant for directing future approaches to the treatment of multi-deregulated diseases.
http://www.ncbi.nlm.nih.gov/pubmed/25119429?dopt=Abstract
CytoDyn Announces Webcast for Annual Shareholder Meeting
VANCOUVER, Wash., Aug. 15, 2014 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that its August 20, 2014 annual meeting of shareholders will be shared live through a webcast that will allow the public to access the audio portion of the meeting, as well as management's presentation.
Webcast Instructions
The live audio webcast will be held on Wednesday, August 20, 2014 at 1:00 p.m. PT / 4:00 p.m. ET. The webcast can be accessed at cytodyn.equisolvewebcast.com/agm-2014 or via the Investors section of CytoDyn's corporate web site at www.cytodyn.com. Web participants are encouraged to go to the web site 15 minutes prior to the start of the event to register, download and install any necessary software. A replay of the webcast will be available until September 20, 2014.
http://finance.yahoo.com/news/cytodyn-announces-webcast-annual-shareholder-190614369.html
PRO140:potent, short-term, dose-dependent, highly significant antiviral activity
We aimed to assess the efficacy, safety, clinical disease progression and immunologic (CD4 count/percentage) and virologic (plasma HIV RNA viral load) markers of PRO 140 for HIV-infected patients in randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) .....
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008439.pub3/abstract
Percentage orphan drug designation reviews completed <90 Days?
Appears more than 80% of orphan drug application reviews are completed in less than 90 days according to the FDA.
http://www.accessdata.fda.gov/FDATrack/track?program=osmp&id=OSMP-OOPD-Percentage-orphan-drug-designation-reviewed-completed-in-90-days-or-less
It's all about the shortest path to market
we all know pro 140 could well serve more than 200k in the US alone but for substitution therapy, <200k is their particular market
breakdown:
US
1.1 million HIV prevalence
902k diagnosed
604k undergoing treatment
390k undergoing treatment ccr5 only
it's a fraction of this 390k number (those with horrible side effects, resistance issues, etc) that would seek/require treatment substitution thus meeting orphan drug requirement of <200k
once on the market, doctors can prescribe for anyone
Securing Orphan Designation May Create Bidding War
The cost of developing a new drug has skyrocketed over the last three decades (almost $2 billion). As a result, Big Pharma is looking at orphan drugs ... here's why.
last month's NY Times:
Developing orphan drugs is cheaper. They receive expedited approval from the F.D.A. Clinical trials are inherently less expensive because the drugs are aimed at a small population. And insurance companies are willing to pay $100,000 a year for a drug that few patients will use.
“Companies are flocking to rare diseases,” said John LaMattina, a former head of research at Pfizer who now writes a blog about pharmaceutical research. “They might only make $500 million in sales a year, but their costs are much lower.”
Patricia Danzon of the Wharton School of the University of Pennsylvania suggests recalibrating the regulatory burden to favor research in drugs with a broader potential footprint. “The decks have been stacked in favor of orphan drugs,” she said
http://www.nytimes.com/2014/07/23/business/a-dearth-of-investment-in-much-needed-drugs.html?smid=tw-share
Encouraging to hear remaining 28 will be dosed starting this week
2 of the 5 failures were test screening issues, they weren't R5 and shouldn't have been in trial (other 3 still being re-tested)
PROGRESS!
What questions do you have for Nader Monday?
Some things I thought of that need to be answered or clarified ....
-- When will you know if the other 4 failures were also due to inaccurate trofile screening
-- Have you started screening for the other 28 participants and are you able to use a more accurate trofile screening method to prevent more failures
-- Do you plan on filing for orphan or breakthrough designation
-- Is trial result data being shared in real time with prospective partners/big pharma (are you being proactive vs waiting for the phone to ring)
-- Do you expect to finish the trial for the remaining 28 participants before your cash is depleted
Will someone PLEASE step up and challenge Gilead
Gilead now serves about 85% of treated HIV patients in the United States... we think Gilead's HIV franchise will peak at $11.7 billion in 2018 .... If Gilead's HIV franchise does not maintain its superior efficacy and safety status, a large portion of its sales foundation could be at risk
http://analysisreport.morningstar.com/stock/research?t=GILD®ion=usa&culture=en-US&productcode=MLE
Gilead simply mixes, matches and tweaks their same old drugs to extend patent life and increase price... it's time for a serious paradigm shift in HIV treatment.
Something that can be self administered and will last weeks or even MONTHS at a time ... something that isn't just another a toxic, EXPENSIVE drug. Something that actually works with the immune system making a big-time improvement in a patient's quality of life.
Good Question: What is $CYDY worth?
Today's news revealed half the participants in the current substitution trial have demonstrated 8 weeks of Successful Drug Holiday on PRO 140 Monotherapy ... and one of the five who didn't shouldn't have been in the trial, likely the case for the other four.
The first of these 'failures' was documented to be a patient qualification screen failure rather than a drug failure. The Company believes that this is a likely cause in the other failures.
-- HUGE if they can confirm the other 4 failures were also due to qualification screen failure --
So what does this mean for marketshare/stock price?
Back of the napkin please ....
there are approx. 100 mil shares out
and according to the investor presentation on their website (p 15)
http://www.cytodyn.com/media/presentations
Market size for 2 months of HAART is about:
$2.6 Billion
how about if the final tally confirms it works for 12 weeks ...
Market size for 3 months of HAART is about:
$3.9 Billion
and if it works for 12 weeks? Might it also work as a primary treatment, then what kind of number are we looking at???
And don't forget it's potential use in Cancer:
CCR5 Inhibitor (PRO140) for Cancer Treatment
So many potential uses beyond HIV:
Breast and Prostate ...
www.abstractsonline.com/plan/ViewAbstract.aspx?mID=3086&sKey=cbbfc7f0-efdb-4f78-9cd6-ea871bc11110&cKey=77a757fe-9187-40c3-8e4b-aa1eec6e4d14&mKey=9b2d28e7-24a0-466f-a3c9-07c21f6e9bc9
Atherosclerosis ....
http://www.aidsrestherapy.com/content/10/1/11/abstract
Staph Infections ...
http://communications.med.nyu.edu/media-relations/news/drug-used-treat-hiv-might-defuse-deadly-staph-infections
HIV medicine could inhibit cancer cells from spreading
Read more: http://medcitynews.com/2013/10/hiv-medicine-inhibit-cancer-cells-spreading/#ixzz2vE9mYyss
Prevent neurologic disorders for HIV infected
http://www.ncbi.nlm.nih.gov/pubmed/24051706
Metastatic Colorectal Cancer
http://clinicaltrials.gov/ct2/show/NCT01736813
Therapy for newer, safer HIV meds an option for the majority of HIV-positive patients
The majority of patients taking antiretroviral therapy (ART) that includes drugs associated with long-term side-effects may have the option of switching to a novel regimen that uses newer and safer anti-HIV drugs, according to Australian research published in PLOS One. The single-site study showed that up to 89% of patients had the option of changing to a combination that includes three active newer agents with improved safety and side-effect profiles.
Most HIV patients today have an excellent or even normal life expectancy but drug resistance and side effects of current medications continues to be HUGE problem so a novel, less toxic, preferably long lasting option is needed and this study proves the market for it is HUGE ....
http://www.aidsmap.com/Therapy-with-newer-safer-antiretrovirals-an-option-for-the-majority-of-HIV-positive-patients/page/2866538/
August 18th is exactly 14 weeks from May 13th, day the first patient was dosed for the current sub trial and I think it's time we take stock (pun intended) of where we're at:
Aug 18th happens to fall on the Monday prior to the upcoming shareholder meeting (8/20)....
Should we expect big news 8/20th?
Agenda for the meeting said shareholders will vote on board members, auditor, reverse stock split, compensation and 'any other business as may properly come before...'
No placebo participants and no waiting on peer review so can & will Nader broadcast the results on August 20th? It was a staggered start so some trial participants will still have a week or two left ... can Nader at least share the six, eight, or twelve week results?
Many feel confident the results will be strong and quite compelling. Just look at the prior trial results as evidence/proof. I gotta believe big pharma is watching closely (and hopefuly Nader is sharing results with big pharma as they roll in).
The CYDY hour glass is running low so getting compelling data out to attract new monies or better yet, a deal with big pharma is needed ASAP.
I agree Nader and the board should be pushing for a sale or at minimum a partnership this year. Obviously, much depends on current sub trial results and if FDA gives their blessing by designating P 140 for orphan or breakthrough status which makes it more appealing to potential suitors. Stock price matters most where we finish not where we are today but there is the problem of cash to continue operations into 2015 if a deal isn't struck hence plan B, reverse split. If sub trial results aren't compelling enough to garner a deal then we are left with Drexel and Dr Jacobson who hasn't even started so looking at min 18 months before he finishes and gets peer reviewed.
Let's hope the substitution trial results are as powerful as many of us expect them to be to garner at least a partnership with big pharma who will keep the lights on, pay for phase 3 trials and likely laced with milestones for a potential 7 figure payout
I think recently minted Paulson investors and insiders (i.e. board members) are already in Nader's corner on this and hold a majority shares for this to pass with relative ease. My sense is we will know in just a few short months if this is even necessary though ....
Hopefully the reverse split is a mute point and simply Nader's plan B in case they aren't bought out by year's end. Around October, we should have FDA's comment on the current substitution trial and I think Nader has enough $ to last til November/December. If the FDA gives em breakthrough or orphan drug designation, we could have big pharma's like Teva lining up with their offers to buy.
Lower toxicity HIV drugs may improve life expectancy
“The side effects of treatment remain one of the primary reasons that HIV drug regimens are discontinued,” Mark Roberts, MD, MPP
... They found that in young patients with high viral loads, the availability of new drugs could result in a 4.9% increase in life expectancy and an 8% increase in quality-adjusted life expectancy
Among all the great attributes of PRO 140 like keeping viral loads down for several weeks at a time with just one self injection, what is another fantastic trait? It's tolerability and lack of toxicity!
http://www.healio.com/infectious-disease/hiv-aids/news/online/%7B325d8b30-14a7-486c-bdc6-623f606d275d%7D/lower-toxicity-in-future-hiv-drugs-may-improve-life-expectancy
CytoDyn, Inc (CYDY) Shares Surpass Important Resistance Level
"The last time shares were above this important $1.00 resistance level was last year, when stock reached $1.50 in October. A good amount of trading volume (currently at 160,000 shares) may maintain these levels and push the stock higher....
There is no question that the market for immune deficiency viruses is a massive one. A breakthrough in innovative therapies is what CytoDyn’s team is striving to achieve.
CYDY shares haven’t traded below $0.50 since 2009, which proves that the stock has some sustainability above this level.
Trial and error phase is an inherent reality of the biotechnology sector. Not knowing if clinical trials will obtain expected results is part of an investor’s risk/reward bet on the company’s stock.
However, the movement we have seen since June cannot be taken for granted and could represent a breakthrough performance for CYDY."
http://www.superstockprofits.com/news/245-cytodyn-inc-cydy-shares-surpass-important-resistance-level#.U6NvGbvn-P9
CCR5 antagonists inhibit the proliferation of metastatic prostate cancer cell lines
"Chemokine receptor CCR5 plays an important role in the pro-inflammatory environment that aids in the proliferation of prostate cancer cells ... The developed CCR5 antagonists were able to antagonize CCR5 at a micromolar level and inhibit the proliferation of metastatic prostate cancer cell lines."
http://www.urotoday.com/Investigative-Urology/design-syntheses-and-characterization-of-piperazine-based-chemokine-receptor-ccr5-antagonists-as-anti-prostate-cancer-agents-abstract.html?utm_source=dlvr.it&utm_medium=twitter
Drug-resistant HIV pandemic a 'real possibility', expert claims
Article provides more evidence that we can't continue to rely on current meds to treat HIV forever... a humanized monoclonal antibody like PRO 140 offers a real solution for real problems facing millions around the globe.
Professor Jeremy Farrar said that “the spectre of drug-resistant HIV” threatened to have “a huge impact” in the next 20 years, if drugs which have made vast improvements to the life expectancy of patients since 1990s become less effective ....said that it was “inevitable” that resistance to HIV would increase because it was a virus which could easily mutate ... We [also] need to ensure we continue to develop new compounds rather than become complacent about the existing drugs we have .... In Europe, there are estimated to be 25,000 deaths every year from drug-resistant infections ...Professor Woolhouse, of Edinburgh University said that, in terms of the threats posed to human health by both AMR and climate change, he was “much more concerned about antimicrobial resistance”.
http://www.independent.co.uk/life-style/health-and-families/health-news/drugresistant-hiv-pandemic-is-a-real-possibility-expert-claims-9420833.html
Will the Treatment Substitution Trial Be Successful?
Let's see ... they have already tested PRO 140 in 6 previous trials (four Phase 1/1b and two Phase 2a) - all demonstrating effectiveness and safety. No toxicity even as dosage was increased to extend potent, long-lived antiviral activity. Pro 140 has proven to last 4+ weeks in prior trials.
Viral loads reached their nadir at day 12 posttreatment and remained significantly (P < 0.01) reduced through day 29 for both PRO 140 dose groups
http://www.ncbi.nlm.nih.gov/pubmed/20660677
I don't see any reason why the 2b results won't be successful.
Then the question (for an investor) becomes when will these results become public and what kind of market share will it grab?
US alone I've heard $billions ... there are over 300,000 HIV+ Americans (ccr5 tropism) that could benefit from this alternative therapy.
It could save patients thousands of dollars a year and provide relief from the current standard of treatment's (HAART) horrible side effects.
I agree but at least they aren't selling ...
@inversor86 - sold to focus on Cancer only which is ironic as PRO 140 may have been their best Cancer fighting product (see prior post). And I believe CytoDyn was a client of NDA before appointing Dr Feigal as their CMO
@sanMillion - zfp many, many, many years away (if ever) - not to mention the cost which would be out of reach for 99.99% of people with HIV. PRO 140 already proven to work in no less 6 prior trials as it heads to phase 2b with grant $ and FDA fast track designation
Blocking cancer metastases with CCR5 HIV Entry Inhibitors
Breast and prostate....
PRO 140 may capture both HIV and cancer market share, that could be billions in annual sales
http://blogs.jefferson.edu/atjeff/2014/04/04/presenting-latest-research-jeffersons-breast-cancer-symposium/#HIVDrugs