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This is the first time I have seen a mention of "diagnostic business".
From the 10K, Page 59.
Results of Operations
Clinical Trials Update
Phase 2b Extension Study for HIV, as Monotherapy
Currently, there are four patients in this ongoing extension study and each has surpassed six years of suppressed viral load with leronlimab as a single agent therapy. This extension study will be discontinued upon any FDA approval of leronlimab.
Phase 2b/3 Pivotal Trial for HIV, as Combination Therapy
This trial was successfully completed and is the basis for our current BLA, for which the remaining two sections were submitted to the FDA in April and May of 2020. The completion of the filing is subject to the Company providing additional information requested by the FDA. This trial for leronlimab as a combination therapy to existing HAART drug regimens for highly treatment experienced HIV patients achieved its primary endpoint with a p-value of 0.0032. Nearly all patients who have completed this trial have transitioned to a FDA-cleared rollover study, as requested by the treating physicians to enable the patients to have continued access to leronlimab.
Rollover Study for HIV as Combination Therapy
This study is designed for patients who successfully completed the pivotal Phase 2b/3 Combination Therapy trial and for whom the treating physicians request a continuation of leronlimab therapy in order to maintain suppressed viral load. This extension study will be discontinued upon any FDA approval of leronlimab.
Phase 2b/3 Investigative Trial for HIV, as Long-term Monotherapy
Enrollment for this trial is now closed after reaching 500 patients. This trial assesses the subcutaneous use of leronlimab 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 the proportion of participants with a suppressed viral load to those who experienced virologic failure. The secondary endpoint is the length of time to virologic failure. We completed the evaluation two higher-dose arms, one with 525 mg dose (a 50% increase from the original dosage of 350 mg), as well as a 700 mg dose. We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks. This trial has also been used to provide safety data for the BLA filing for leronlimab as a combination therapy. In view of the high responder rate at the increased dosage levels, coupled with the newly developed CCR5 occupancy test, we filed a pivotal trial protocol with the FDA for leronlimab as a monotherapy. Upon finalization with the FDA of the pivotal trial protocol for monotherapy, the Phase2b/3 investigative trial will likely be discontinued. In the interim, several patients are continuing in an extension study who have requested continued access to leronlimab.
Cancer and Immunological Applications for Leronlimab
We are continuing to explore opportunities for clinical applications for leronlimab involving the CCR5 receptor, other than HIV-related treatments, such as inflammatory conditions, autoimmune diseases and cancer.
The target of leronlimab is the immunologic receptor CCR5. We believe that the CCR5 receptor is more than the door for HIV to enter T-cells: it is also a crucial component in inflammatory responses. This could open the potential for multiple pipeline opportunities for leronlimab.
The CCR5 receptor is a protein located on the surface of white blood cells that serves as a receptor for chemical attractants called chemokines. Chemokines are the key orchestrators of leukocyte trafficking by attracting immune cells to the sites of inflammation. At the site of an inflammatory reaction, chemokines are released. These chemokines are specific for CCR5 and cause the migration of T-cells to these sites promoting further inflammation. The mechanism of action of PRO 140 has the potential to block the movement of T-cells to inflammatory sites, which could be instrumental in diminishing or eliminating inflammatory responses. Some disease processes that could benefit from CCR5 blockade include transplantation rejection, autoimmunity and chronic inflammation such as rheumatoid arthritis and psoriasis.
Due to leronlimab’s MOA, we believe leronlimab may have significant advantages in terms of reduced side effects over other CCR5 antagonists. Prior studies have demonstrated that leronlimab does not cause direct activation of T-cells. We have reported encouraging human safety data for our clinical trials with leronlimab in HIV-infected patients.
We have initiated our first clinical trial with leronlimab in an immunological indication – a Phase 2 clinical trial with leronlimab for GvHD in reduced intensity conditioning (“RIC”) patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) who are undergoing bone marrow stem cell transplantation. GvHD represents an unmet medical need, with patients who contract GvHD during stem cell transplant having a significantly decreased 1-year survival rate with relapsed GvHD as the leading cause of death. Our pre-clinical study in GvHD has been published in the peer-reviewed journal Biology of Blood and Marrow Transplantation. The FDA has granted orphan drug designation to leronlimab for the prevention of acute GvHD.
GvHD is a risk when patients receive bone marrow stem cells donated from another person. GvHD is a serious complication that limits the use of Bone Marrow Stem Cell (“BMSC”) transplantation in patients with blood cancers. 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.
The CCR5 receptor, the target for leronlimab, appears to be an important mediator of GvHD, especially in the organ damage that is the usual cause of death. We believe that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and by blocking this receptor from recognizing certain immune signaling molecules could be a viable approach to mitigating acute GvHD. The potential of leronlimab to prevent this life-threatening condition could help extend the use of BMSC transplantation to effectively treat more patients.
COVID-19
Phase 2 Trial to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19).
This is a two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection was completed in July 2020. Patients were randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo were administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period and Follow-Up Period. A total of 75 subjects were randomized 2:1 (active drug to placebo) in this study. The primary outcome measures are clinical improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough). Secondary outcome measures include: (1) time to clinical resolution, (2) change from baseline in National Early Warning Score 2 (NEWS2), (3) change from baseline in pulse oxygen saturation, (4) change from baseline in the patient’s health status on a 7-category ordinal scale, (5) incidence of hospitalization, (6) duration (days) of hospitalization,
(7) incidence of mechanical ventilation supply, (8) duration (days) of mechanical ventilation supply, (9) incidence of oxygen use, (10) duration (days) of oxygen use, (11) mortality rate, (12) time to return to normal activity. Enrollment was completed in July 2020 and the Company has recently reported positive safety results. The topline report from the trial, including efficacy and complete safety data, is expected to be submitted to the FDA in August 2020.
Phase 3 Trial to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019(COVID-19).
This is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo will be administered via subcutaneous injection. The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee for the ongoing Phase 3 trial completed its first safety review of patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 of the 169 patients enrolled in the Phase 3 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue. As such, the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol.
Phase 2 Trial for Graft-versus-Host Disease
This Phase 2 multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab as an add-on therapy to standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with AML or MDS undergoing allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, we announced that the FDA had granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, we filed amendments to the protocol with the FDA. The amendments included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning (“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive leronlimab. The amendments also provide for a 100% increase in the dose of leronlimab, to 700 mg, to more closely mimic pre-clinical dosing. The next review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Due to the necessary prioritization of limited capital, enrollment under the amended protocol has been temporarily delayed.
Phase 1b/2 Trial for Triple-Negative Breast Cancer
This trial is to evaluate the feasibility of leronlimab combined with carboplatin in patients with CCR5+ metastatic triple negative breast cancer. The Phase 1b portion is a dose escalation phase with three dose levels (cohorts) of leronlimab in combination with a fixed dose of carboplatin. The Phase 2 portion is a single arm study with 30 patients to test the hypothesis that the combination of carboplatin intravenously and maximum tolerated dose of leronlimab subcutaneously will increase progression free survival. In May 2019, the FDA granted leronlimab Fast Track designation for use in combination with carboplatin. The change in circulating tumor cells (“CTCs”) number will be evaluated every 21 days during treatment and will be used as an initial prognostic marker for efficacy. The first patient was treated in September 2019.
Compassionate Use Study of Leronlimab in Breast Cancer
This is a single arm, compassionate use study with 30 patients for leronlimab (PRO 140) combined with a treatment of physician’s choice (TPC) in patients with CCR5+ mTNBC. Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 350 mg until disease progression or intolerable toxicity. Treatment of Physician’s Choice (TPC) is defined as one of the following single-agent chemotherapy drugs administrated according to local practice: eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin. In this study, patients will be evaluated for tumor response approximately every 3 months or according to institution’s standard practice by CT, PET/CT or MRI with contrast (per treating investigator’s discretion) using the same method as at baseline.
Basket Trial for 22 Solid Tumor Cancers
This is a Phase 2 study to test the safety and efficacy of leronlimab on 22 different solid tumor cancers, including brain-glioblastoma, melanoma, lung, breast, ovarian, pancreas, bladder, throat, stomach, colon, testicular, uterine, among other indications. The first patient was treated in April 2020.
Licensing Opportunities
We continue to evaluate strategic licensing opportunities and conduct exploratory discussions with third parties with respect to our assets, including pre-clinical and clinical findings for leronlimab for a wide array of clinical indications. As recently completed license agreements demonstrate, such agreements are country or region specific and are limited to a specific clinical indication for leronlimab.
From the 10K -
Page 48
Our business success partially depends on our ability to successfully commercialize novel diagnostic tests and services, which is time consuming and complex, and our development efforts may fail.
Page 49
The commercial success of our prospective diagnostic business could be compromised if third-party payors, including insurance companies, managed care organizations and Medicare, do not provide coverage and reimbursement, refuse to enter into contracts with us, or delay payments for our diagnostic tests.
For inhaled therapy, the nebulizer will have a blue tooth connection, so the trial admin will know when the device is used. It will also be connected to an oximiter to continuously monitor the blood oxygen level.
These guys are the real deal !!!
Who is going to sell before a DMC study ?
Based upon the companies' July 16 release, the DMC will evaluate the patient data in the Phase II/III Critical patient study again "in four weeks," which puts the next possible data release on about August 13, Thursday of this week.
So hopefully by Friday we may have a positive outcome.
https://seekingalpha-com.cdn.ampproject.org/c/s/seekingalpha.com/amp/article/4367483-relief-therapeutics-discovers-promising-covidminus-19-killer
Thanks to iPhone, Apple now has 1.5 billion active devices—phones, watches, etc.— used by over a billion people from all across the world. The company added a whopping half billion devices during the last few years alone.
Think about it, nearly one in seven people now carry around an Apple device every day.
Today, those 1.5 billion active devices are the single most important driver of Apple’s business. Even more important than phone sales alone. Because every day Apple earns more and more money from them.
iPhone is no longer Apple’s biggest money maker. It’s services.
That’s why Apple doesn’t care about iPhone prices anymore. It’s goal is simply to put more and more of its phones in people’s hands—at any cost. Because the more people carry iPhones, the more people will buy Apple services.
And it’s working.
Last quarter, Apple’s sales from services roared to an all-time record. But with its push into money-spinning enterprise services, I’m convinced Apple’s growth story is just starting. For this reason, Apple stock sits at the top of my watch list.
https://www.forbes.com/sites/danrunkevicius/2020/08/10/apple-new-era-has-begun/#7745fedd4072
Sounds logical for the price to drop. One day you have a marketplace with 4B to choose from, and the next you have 16B to chose from.
I'm starting a new beat looking at financial conflicts of interest, insider trading, and who's getting rich in the race to develop a coronavirus vaccine.
Send me your tips!
NPR Investigative Correspondent | Send me your tips! | Email: tdreisbach@npr.org or tomdreisbach@protonmail.com | DMs open
Twitter. Tom Dreisbach.
Seen several responses saying StatNews.
So the new Covid advisor, Dr. Scott Atlas
https://news.yahoo.com/dr-scott-atlas-role-advising-002530721.html
was at Stanford from 1998-2012. I wonder if he came across Dr. Bruce Patterson ?
Keeping tabs on the competition ??
So every time CYDY has a Q&A, the first questioner in line is the guy from Wainwright.
Today I read -
Relief is a small Swiss based biotech company and has largely remained under the radar so far. It has no CEO, you as the Chairman have a full-time job being a Healthcare Analyst at the US Investment firm H.C. Wainwright & Co. How is Relief Therapeutics run and how many employees work at the company?
https://themarket.ch/interview/relief-therapeutics-our-drug-could-generate-hundreds-of-millions-of-dollars-per-year-ld.2478
Very heavy reading indeed. Read some of AMRN brief, too much for me to comprehend. But I did read the two Amicus Curiae ones. The BIO one although stating that it had no horse in that race, seemed to me to lean toward AMRN. The one by Aimed was definitely for AMRN. And then I got to page 21,-
III. The District Court’s Obviousness Analysis Is Flawed.
And came across Hotchkiss v Greenwood, so I thought, let me look this up and see what it's about - a freaking 1851 case, about a spindle in a doorknob. If that is part of the basis for the judgement for Defendants, then Heaven help us.
How warped can it get ? Woodcock is in charge.
"Advanced purchasing of therapeutics is going to be slower," said Dr. Janet Woodcock, a Food and Drug Administration official who leads therapeutics development for Operation Warp Speed
"We have to select the most promising ones. We can't just buy advanced purchases of 600 different agents."
US health experts have been particularly optimistic about the odds of monoclonal antibody treatments being effective, in part because the healthcare industry already uses such therapies to treat illnesses like HIV, asthma, Ebola and some types of cancer.
https://www.cnn.com/2020/08/07/politics/antibody-treatments-coronavirus-shortage-government/index.html
Obalon Says Cash Crunch Could Push Company Into Bankruptcy >OBLN
8:46 am ET June 19, 2020 (Dow Jones) Print
By Colin Kellaher
Obalon Therapeutics Inc. on Friday warned that it may need to liquidate or seek bankruptcy protection amid dwindling resources.
The Carlsbad, Calif., company, which develops medical devices to treat obesity, said it only has enough cash and equivalents on hand to fund its operations through the end of the year and that it has thus far been unable to identify a viable alternative for capital raising.
Obalon in March closed its two retail treatment centers and halted manufacturing operations amid disruptions sparked by the coronavirus pandemic.
The company on Friday said that due to significant concerns about an economic recovery and the fact that its Obalon Balloon System isn't currently covered by any kind of private or public health insurance, it doesn't currently plan to reopen the treatment centers or to ship orders to U.S. customers or its former international distributor.
As a result, Obalon said it doesn't expect to report any meaningful revenue for the foreseeable future.
Obalon said it will continue to explore its strategic alternatives and to seek third-party coverage and reimbursement for its product. It said that if it isn't successful in those efforts, it may need to sell or liquidate all or part of its business or file for bankruptcy protection.
Shares of Obalon, which closed Thursday at $1.07, fell 20% to 86 cents in premarket trading Friday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 19, 2020 08:46 ET (12:46 GMT)
Market perspective, agree.
3) Potential on approval on vaccine,
The question is, how long will it work for. See the thing with a vaccine is that you get it, and in some cases it last for years. Any vaccine that is given over the next 6 months, will have no history of efficacy to look back on, it will simply IMO be a panacea.
Any idea how long it is going to take to enroll 1000 participants ? Hope they give updates on enrollment.
Apple Inc. has a secret team working on satellite technology that the iPhone maker could use to beam internet services directly to devices, bypassing wireless networks, according to people familiar with the work.
The Cupertino, California-based iPhone maker has about a dozen engineers from the aerospace, satellite and antenna design industries working on the project with the goal of deploying their results within five years, said the people, who asked not to be identified discussing internal company efforts. Work on the project is still early and could be abandoned, the people said, and a clear direction and use for satellites hasn’t been finalized. Still, Apple Chief Executive Officer Tim Cook has shown interest in the project, indicating it’s a company priority.
Apple’s work on communications satellites and next-generation wireless technology means the aim is likely to beam data to a user’s device, potentially mitigating the dependence on wireless carriers, or for linking devices together without a traditional network. Apple could also be exploring satellites for more precise location tracking for its devices, enabling improved maps and new features.
As Bloomberg has previously reported, Apple also is working on a virtual reality headset to debut as early as 2021, augmented reality glasses for launch after that, MicroLED screens for future devices, new home products, self-driving car technology and a future Apple Watch that can analyze a user’s blood chemistry to determine glucose levels. Apple is also expanding its in-house chip development, seeking to replace Intel Corp. as its Mac processor maker, and Intel and Qualcomm Inc. as the providers of its modem component for phones.
Under Cook, Apple has rapidly expanded its research and development budget, spending $16 billion in the 2019 fiscal year, an increase of 14% from the prior year, according to company filings. One of Apple’s primary goals is to bring more of the technology behind its products in house, which is what work on satellites could eventually enable.
https://www.bloomberg.com/news/articles/2019-12-20/apple-has-top-secret-team-working-on-internet-satellites
Yes, the HIV treatment was why I got in. The possible Covid indication is gravy.
Yes, it's not pretty. However, the point I was making is that drugs can be repurposed, just like Viagra, which was originally for hypertension and angina pectoris.
They post stuff on twitter for fun - a whole lot of outrageous stuff.
Ever heard of thalidomide ?
https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/thalidomide/art-20046534
Perhaps the slide is due to a matter of presentation.
RLFTF"s frontman has a medical "pedigree".
The trials are being done in conjunction with NeuroRx, whose principal's bio is below, what an impressive background.
Chief Executive Officer Jonathan C. Javitt, M.D., M.P.H.
Dr. Javitt has played leadership roles in seven successful healthcare IT and biopharma startups with public exits. He has additionally led drug-development engagements for Merck, Allergan, Pharmacia, Novartis, and Pfizer. He was appointed to healthcare leadership roles under Presidents Reagan, George H.W. Bush, Clinton, and George W. Bush. In the latter role he was commissioned to lead the White House policy for universal adoption of Health IT and establishment of the Office of the National Coordinator. He is a graduate of Princeton University, Cornell University Medical College, Harvard School of Public Health, the Wills Eye Hospital, and Johns Hopkins Medical School . Dr. Javitt has published more than 200 scientific works in the areas of health outcomes and pharmacoeconomics that have been cited by more than 16,000 people.
And have you listened to him -
https://www.youtube.com/watch?v=lgmpS2N8124
Meanwhile BPSR has -
EXECUTIVE LEADERSHIP
Albert Mitrani
CEO & Co-Founder
Board Member
Dr. Maria Ines Mitrani, M.D., PhD
CSO & Co-Founder
Board Member
George Shapiro, M.D., FACC
Chief Medical Officer
Board Member
Ian T. Bothwell
Chief Financial Officer
Board Member
SCIENCE & REGULATORY ADVISORY BOARD
Michael A. Bellio, Ph.D.
Vice President, Manufacturing & Processing
Ivan Santos
Research & Development Scientist
Julian Milberg
Process Engineer
Zanub Abdullah
Cell Processing Specialist
MEDICAL ADVISORY BOARD
Allen J. Meglin, M.D.
Medical Director, Board Member
Bryan Kelly, M.D.
Medical Advisor
Carolyn DeLucia, M.D.
Medical Advisor
Paul Thompson, M.D.
Medical Advisor
Marianne LaBarbera, M.D.
Medical Advisor
Paul Francis Campion, M.D.
Medical Advisor
Sonita Sadio, M.D.
Medical Advisor
Henry C. Sobo, M.D.
Medical Advisor
Rolf Wallin, M.D.
Medical Advisor
Dr. Robert Madda, M.D.
Medical Advisor
Raymond Ishman, M.D.
Medical Advisor
William K. Kapp III, M.D., M.S., FAAOS
Medical Advisor
Stephanie M. Singer, D.O.
Medical Advisor
Dr. Julian Gershon, D.O.
Medical Advisor
Rebecca Murray, F.N.P.
Medical Advisor
Juan Chavez, M.D.
Medical Advisor
Fernando Pinto, M.D.
Medical Advisor
Michale J. Barber, M.D.
Medical Advisor
Alvaro J. Ocampo, M.D. MPH
Medical Advisor
David C. Socol, M.D.
Medical Advisor
John R. Baird, M.D.
Medical Advisor
Ken Sharlin, M.D., M.P.H., IFMCP
Medical Advisor
Randolph Whipps, M.D., F. A.C.C.
Medical Advisor
Riley J. Williams III, M.D.
Medical Advisor
Barry Kuttner, M.D., PhD
Medical Advisor
Mounir Wassef, D.O., FAOCD, FAAD
Medical Advisor
Robert Neal Rouzier, M.D.
Medical Advisor
Bennett L. Willard, D.O.
Medical Advisor
Dan Sperling, M.D., D.A.B.R.
Medical Advisor
Glenn Charles, D.O.
Medical Advisor
Eugene Rajaratnam, M.D., F.A.C.S.
Medical Advisor
Matthew Lief, M.D., F.A.C.S.
Medical Advisor
Josh Sandell, D.C., D.A.C.B.S.P., A.T.C., C.S.C.S., I.C.S.S.D.
Medical Advisor
Billy Ray Ledbetter, M.D.
Medical Advisor
Mohammed Siddiqui, M.D.
Medical Advisor
Matthew Burnett, D.C., C.C.S.M.S, C.F.S.S.
Medical Advisor
FINANCIAL & REGULATORY
ADVISORY BOARD
Larry Ziff
Financial and Regulatory Advisor
STRATEGIC ADVISORS
Raymond Zoeller
Strategic Advisor
Humanigen, HGEN is here -
https://www.humanigen.com/about-humanigen
Landmark Hospitals Compassionate Use Study for Critical COVID-19 Patients Evidences Potential for Allogenic Biologic Product
MAY 30, 2020 | ALLOGENIC BIOLOGIC PRODUCT, ARDS, CORONAVIRUS, COVID-19, CYTOKINE STORM, INVESTOR WATCH, POPULAR POSTS, REGENERATIVE MEDICINE, SARS-COV-2, STEM CELL
Landmark Hospital manages six long-term acute care hospitals across the Southeast United States and recently announced its decision to offer an investigational allogenic biologic product derived from amniotic fluid to patients with advanced COVID-19 conditions under the U.S. Food and Drug Administration (FDA) approved Compassionate Use pathway. Two patients at Landmark Hospital of Athens, Georgia, were treated last week with the first doses of the regimen, known as Organicell Flow. Reports are that intravenous infusions of the biologic product were administered safely to the two patients, and they are clinically stable.
A Key Challenge with COVID-19
The majority of COVID-19 cases are mild, with flu-like conditions for a couple of weeks. However, when cases of COVID-19 do escalate into severe and critical cases, the risk significantly rises for organ damage and death. While the world waits for a safe and effective vaccine, If safe and effective treatments are developed for this class of patient—in addition to the development of safe and effective products for the mild cases—then the overall risk of COVID-19 becomes mitigated until the vaccine is approved.
All of this is important as worldwide experiences direct the medical community to the risks of the severe to critical cases of COVID-19—where a progressive decline in lung function represents a major cause of death in patients infected with SARS-CoV-19; those patients who are admitted into the ICU and thereafter require intubation face high mortality rates. Finding a number of effective and safe ways to treat this patient class, including those with severe Acute Respiratory Distress Syndrome (ARDS) and the overall pandemic risk, wanes as the mortality rate will decline. Hence the importance of the Landmark Hospitals Compassionate Use case discussion.
A Possible Treatment for the ‘Cytokine Storm’?
With severe to critical cases of COVID-19 comes the need for oxygen therapy, mechanical ventilation, and medications to maintain the patient’s blood pressure, reported Landmark Hospitals in a recent press release. But patients at this stage of the disease, especially if they have other risk factors or comorbidities, are at risk of their condition escalating into the so-called cytokine storm. CEO William K. Kapp III, MD, Landmark Hospitals founder, commented, “COVID-19 patients can experience immune activation and the appearance of the cytokine storm syndrome (CSS), which causes damage to lungs and other organs and can lead to death. Landmark Hospitals obtained Compassionate Use approval to administer Organicell Flow because previously collected research showed it might have therapeutic potential in reducing the cytokine activation cycle, which will impact COVID-19 infection severity.”
What is Organicell Flow?
Manufactured by Organicell Regenerative Medicine, Inc., this is a novel treatment derived from human amniotic fluid (HAF) that is voluntarily donated during planned Caesarean section surgeries. The product contains over 300 growth factors, cytokines, and chemokines, as well as hyaluronic acid exosomes.
Is there any comparable treatment on the market for COVID-19?
No. There is currently no specific antiviral therapy available for patients with COVID-19. The FDA-approved Compassionate Use pathway allows for the immediate use of the experimental biologic.
Is this effort like a Clinical Trial?
Yes, it is. The product hasn’t been approved for marketing via the standard process (e.g., three clinical trial phases, filing for marketing, etc.). The product’s maker, Organicell, received Emergency Compassionate Use Investigational New Drug applications (eINDs) by the FDA.
Moreover, as Dr. Kapp quoted in his firm’s press release, Landmark Hospital Athens will be collecting patient data (again under Compassionate Use) and perform ongoing analysis as to the impact—the affect on the two patients—and thus “guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage.”
What are some more details on this Compassionate Use eIND use case?
Upon FDA eIND approval, Landmark Hospital immediately treated the two critically ill COVID-19 patients, in their mid-70s, with the biologic product.
What have been the results thus far?
Landmark Hospital reports that the two patients are clinically stable while the vendor, Organicell, reported in their press release that “Organicell Flow resulted in a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data.” For example, they report that “the patients are no longer intubated” and appear more alert with positive vital signs and oxygenation. Moreover, at least as of this writing, there doesn’t seem to be the organ damage associated with many SARS-CoV-2 cytokine storm cases.
Has Organicell Flow met its primary and secondary endpoints for the Compassionate Use eIND?
Yes. Dr. George Shapiro, Chief Medical Officer of Organicell, reported: “We are very pleased that Organicell Flow, administered intravenously, has to date met all of the primary objectives of safety and secondary clinical objectives of improved ICU status and reduction in the sequential organ failure assessment (SOFA) score.”
Meanwhile, from the provider (site) perspective, Dr. Anthony Sagel, Chief Medical Officer at Landmark Hospital, reported that “The first patient has improved considerably and is now off the ventilator with normal-appearing lungs on their chest X-ray. In addition, their mental status continues to improve with normal kidney function. The second patient has also been systemically improving, including their kidney and respiratory function. Their acute delirium has improved and is communicating well with the family. Both patients are ready to be discharged from the ICU.”
What are the next steps?
The clinical trial protocol established under the eIND is that each of the patients will continue to be monitored on their health vitals for 60 days. Based on the continued favorable results, the product developer, Organicell, may seek other approvals from the FDA to treat other severely ill patients. They will need to do this with the FDA on a case by case basis. Note, the company has registered an FDA-compliant clinical trial with Landmark Hospitals.
The Forthcoming Study
The forthcoming Phase I/II study, sponsored by Organicell, is led by Landmark Hospitals with the purpose to evaluate the safety and potential efficacy of Intravenous Infusion of Organicell Flow for treatment of moderate to Severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs. placebo. Scheduled to start in May 2020, the study will run through December 30, 2020. The Principal Investigators will combine Dr. Kapp from Landmark with Dr. Mitrani and Dr. Shapiro from Organicell.
The Product
Organicell Flow is a natural and acellular product derived from amniotic fluid and is manufactured to retain the naturally occurring hyaluronic acid, proteins, and exosomes present in perinatal fluid without the addition or combination of a substance or diluent. Organicell products are manufactured in cGMP compliant labs and are tested for sterility, endotoxin levels, hyaluronic acid, protein analysis, and exosomes composition. Exosomes are nano-sized extracellular vesicles that mediate cell-to-cell communication and affect cell function and behavior. For an overview of the science of the product, see this link.
Organicell Regenerative Medicine, Inc.
Publicly traded, Organicell was founded in 2008 by Albert Mitrani, Chief Executive Officer, and Dr. Mary Mitrani, Chief Scientific Officer. Based in Miami, Florida, Organicell is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. With under 25 employees, they have three COVID-19 product initiatives in their growing pipeline. With clinical trials, the company previously collaborated with the University of Miami to complete pre-clinical studies in therapeutic areas such as pediatric pulmonary disorder.
A Challenged Past
Publicly traded in the form of a penny stock type of equity asset class, the company must disclose material information to the Securities Exchange Commission (SEC). In their latest 10K, those investors interested can read about the company—how it has faced a tumultuous past attempting to navigate an increasingly regulated world involving the business of selling and distributing regenerative biologic therapies based on proprietary amnion placental tissue-derived products to doctors and hospitals. With toughening regulatory stances from the FDA, (see Section 351 of the Public Health Services Act) the company, on the one hand, was making considerable scientific breakthroughs; but on the other hand, it was short on capital and business talent. The financial considerations are beyond the sphere of this article, but suffice to say the fact that the company is still around to attempt to save COVID-19 patient lives is a testimony to the survival instincts of its two founders (who happen to be spouses)—Albert Mitrani and Dr. Maria Mitrani. 69.48% of this company is controlled by the company’s Board and executive officers Manuel E. Iglesias—via MBC LLC, and executive officers Albert Mitrani, Dr. Maria Mitrani as well as Ian T. Bothwell and Robert Zucker. For those that seek a case study in business intrigue, read the annual statement.
About Landmark Hospitals
Established to form regional hospital referral centers for medically complex patients in need of intensive post-acute care, they established their first regional long-term acute care hospital in Cape Girardeau, Missouri, in 2006 and has steadily grown to seven facilities in four states. They are comprised of the seven operational hospitals, each of which was built in the last eight years. They operate in Missouri, Georgia, Utah, and Florida.
The Organicell Flow Study Lead Research/Investigator
Dr. William Kapp, MD, FAAOS
Call to Action: TrialSite News will monitor the Landmark Hospitals and forthcoming study carefully. The data points currently from the Compassionate Use are only two patients, so no conclusions can be derived. However, if the study commences and most, if not all, of the 20 patients targeted do well, then it becomes more probable that Organicell is on to something special.
https://www.trialsitenews.com/landmark-hospitals-compassionate-use-study-for-critical-covid-19-patients-evidences-potential-for-allogenic-biologic-product/
Dr. WilliamKapp is an orthopedic surgeon based in Naples, FL. He is currently the Chairman and CEO at Landmark Hospitals, the CEO of the Technomad, the CEO of the Longevity Performance Center, and the CEO of the Longevity BioImaging Center. He is also an active surgeon at the Landmark Hospital of SW Florida. He is a physician who specializes in the diagnosis and surgical treatment of injuries and disorders involving the musculoskeletal system, such as hip replacements and arthroscopic knee surgery.In addition to treating trauma to the musculoskeletal system.Dr. Kapp also treats sports injuries, degenerative diseases, infections, tumors, and congenital disorders. His experience as a Flight Surgeon in the Air Force enabled him to provide support to pilots in examinations (flight physicals) and areas other than those solely based on orthopedic situations. His continuing role as a private pilot ensures that prevention is as important as corrective surgery.
Interest that the other trial is in Russia.
https://clinicaltrials.gov/ct2/show/NCT04491240?term=Organicell&draw=2&rank=2
Also Therametrics popped 150% today also.
https://finance.yahoo.com/quote/0QKQ.L/profile?p=0QKQ.L
2.11B outstanding, no worries, I suspect a significant amount may be held by it's parent company, Therametrics Discovery AG. https://www.dnb.com/business-directory/company-profiles.therametrics_discovery_ag.7be6c3a0d8a048cdb715797673005b9b.html#related-companies
https://www.acxit.com/en/therametrics-relief/
The trials are being done in conjunction with NeuroRx, whose principal's bio is below, what an impressive background.
Chief Executive Officer Jonathan C. Javitt, M.D., M.P.H.
Dr. Javitt has played leadership roles in seven successful healthcare IT and biopharma startups with public exits. He has additionally led drug-development engagements for Merck, Allergan, Pharmacia, Novartis, and Pfizer. He was appointed to healthcare leadership roles under Presidents Reagan, George H.W. Bush, Clinton, and George W. Bush. In the latter role he was commissioned to lead the White House policy for universal adoption of Health IT and establishment of the Office of the National Coordinator. He is a graduate of Princeton University, Cornell University Medical College, Harvard School of Public Health, the Wills Eye Hospital, and Johns Hopkins Medical School. Dr. Javitt has published more than 200 scientific works in the areas of health outcomes and pharmacoeconomics that have been cited by more than 16,000 people.
See his interview here -
My response was to another post which mentioned the Drs. Javitt brothers, who are involved with NeuroRx. I am aware of RLFTF, and I find 2.11B somewhat scary.
Or was it MRNA ? but definite deja vu.
Extract from AMRN latest 10Q.(End of August will soon be here.)
In January 2020, Acasti announced topline results of the TRILOGY 1 trial of CaPre. The study did not reach statistical significance and further analysis in underway. In April 2020, Acasti announced that it filed a meeting request with the FDA to discuss the TRILOGY 1 data and align on the interpretation of the results. Acasti also will seek FDA input on revisions to the pre-specified TRILOGY 2 statistical analysis plan, or SAP, and on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti stated that it received a written response from the FDA in June 2020 confirming that the FDA will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as per the original SAP and supporting Acasti’s conduct of exploratory post-hoc analyses in TRILOGY 1, depending on the outcome of TRILOGY 2.
Accordingly, Acasti may be required to conduct an additional clinical trial before submitting an NDA. Acasti also stated that they expect to announce topline results of TRILOGY 2 at the end of August. NDA submission (if any) and resultant review/approval timelines will be announced following completion of TRILOGY 1 and 2 data analysis.
Didn't this not happen a week or 2 ago with GILD ?
NeuroRX is private.
Not the first to market, but once they got in, they took leadership of the segment. For the August 31 price, I'll go with $480.00
Last time I did a prediction - July 2, I said $420 which was a miss by $5.66
morokoy Member Level Thursday, 07/02/20 03:45:05 PM
Re: Bigman7100xxx post# 134581 0
Post # 134586 of 135029
July 31, $420
That probably explains the 93.5M shares traded vs the average of 33.5M according to NASDAQ https://www.nasdaq.com/market-activity/stocks/aapl
Guess there was a lot of profit taking, so the Robinhood folks are going to get screwed. I am looking to buy at around $412 or sub $400 and hold until around 9/15, and hopefully sell some of the bonus at $110
Reason - am buying to round out an odd lot situation that the bonus will cause, plus make a few $$ on the trade. Not much, just about 270.
My statement for 5/31/14 shows a price of $633.00
Statement at 6/30/14 shows $92.93 x7 = $650.51
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Is this the biggest one day jump ? And look at volume, 2x the average.
Agree with you summation. Get $25M from discounted note of $28.5M, so that's a cost of $3.5M, then after 1 year interest is $2.85M, so a return of $6.35M on $25M is 25.4% - now it begins to add up.
My guess is $7.50 tops tomorrow, and the CC is a nothing burger. Stay tuned for a future update.
Mostly covered calls.