Blood Purification companies discussionWhen I purchased Stellar Biotechnologies, it was a speculative investment with a compelling story. These are the microcap stocks I like to get involved with. Holding it for the past year was a roller coaster ride, and gave me reason to question my investment. The more research I did, the more I felt confident in the investment, so when it slid down to the mid .30 cents range, I bought more shares. ”Catching a falling knife” is usually frowned upon in the investment community, but its the only way to make a small fortune when you stumble upon a legitimate company with untold upside.
I’ve been doing the same with 2 biotech companies in the field of blood purification. Whether it be a virus (hiv…etc) , exosomes (cancer related), cytokines, sepsis, chemical and biological weapons, the removal of harmful items from the bloodstream holds amazing promise for the future. The 2 companies I have holdings in are Aethlon Medical Inc (AEMD) and Cytosorbents (CTSO), and I’m writing this blog to open a discussion on them. Being a member of the irregulars has led me to the conclusion that there are many people of various skill-sets on this forum that like to delve into a company and their prospects, so I welcome all Gumshoe’ers to put there 2 cents in on these 2 issues. The websites for each are:
http://www.aethlonmedical.com/
and
http://cytosorbents.com/
Running out now, so no time to post more about these companies, but put them on your radars and I would love some feedback from the community.
Thanks also to the blind squirrel Jim, who directed me to open a new blog about these companies, pleasure to have him on the site.
Take care all and have a wonderful weekend.
RV
This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.
Some great news from AEMD dealing with brain cancer:
Aethlon Medical and Exosome Sciences Expand Brain Research Discoveries to Include Isolation of Glioblastoma Biomarker and Therapeutic Target
SAN DIEGO, March 19, 2014 /PRNewswire/ — Aethlon Medical, Inc. (OTCQX:AEMD), and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced today that researchers have isolated brain-derived exosomes released into the bloodstream from aggressive brain tumors. Through the use of proprietary size exclusion/lectin/antibody-capture techniques, the Aethlon-ESI research team was able to identify, quantify, and characterize circulating Glioblastoma multiforme (GBM) exosomes, which hold promise as both a disease biomarker and therapeutic target as GBM exosomes are shed into the circulatory system to promote tumor growth and stimulate angiogenesis.
Aethlon Hemopurifier
“Building on our proprietary method to identify, quantitate and characterize brain-derived exosomes, we now have the ability to detect this aggressive cancer early and aid in its treatment,” stated ESI Chief Scientific Officer, Dr. Douglas Taylor.
Aethlon Medical develops therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions. The Aethlon Hemopurifier® is a first in class medical device that addresses a broad-spectrum of viral pathogens as well as tumor-secreted exosomes that promote cancer progression and suppress the immune system of cancer patients. Aethlon is currently preparing to launch the first FDA approved clinical study of Hemopurifier® therapy in the United States. ESI was established by Aethlon to develop non-invasive exosome-based “liquid biopsies” that diagnose and monitor acute and chronic disease conditions.
GBM represents the most common, per capita costly and uniformly lethal primary brain tumor. GBM comprise 23% of primary brain tumors in the US and is the most commonly diagnosed brain tumor in adults aged 45-74 with men being more frequently diagnosed than women. The prognosis remains poor despite aggressive treatment modalities. Over the past decade, a median survival time of 12 months has only been marginally improved to 14.6 months as a result of advances in chemo/radiation and the use of molecularly targeted agents. Beyond being a candidate target for Hemopurifier® therapy, the discovery of circulating GBM-exosomes offers a potential new paradigm in GBM clinical management through a platform technology to predict tumor regression or progression.
“The ability to characterize disease specific exosomes in circulation will enable improved diagnosis to identify type and grade of these most challenging of brain tumors and may additionally help to advance novel treatment strategies,” stated Dr. Cicek Gercel-Taylor, Clinical Research Director at ESI.
To date, there have been two critical barriers to successful GBM treatment. First, there currently is no method for evaluating the dynamic changes in GBM during therapy. Standard imaging approaches do not provide metrics of tumor-specific genetic/phenotypic changes and operative information is expensive, potentially morbid and limited by errors in topographic sampling. Second, clinicians, lacking tumor-specific parameters, are unable to effectively monitor responses to therapy over short time frames. These limitations are derived from the difficulty in obtaining repeated biopsies of tumor tissue, and the confounding effects on tumor MRI of necrosis, inflammation, surgical artifact and edema. Additionally, the appearance of GBM by current imaging techniques is not specific, since other lesions such as abscess, metastasis, and other entities may have a similar appearance. As a result, clinicians have not been able to adequately evaluate therapeutic agents designed to target GBM. The objective of the Aethlon-ESI team is to extend and improve GBM patient quality of life by resolving the clinical challenges of monitoring patient response to both established and candidate therapies.
Earlier this month, the Aethlon-ESI research team disclosed that it was also to isolate brain-specific biomarkers that could have implications in the diagnosis, monitoring and treatment of Alzheimer’s Disease (AD), Chronic Traumatic Encephalopathy (CTE) and Traumatic Brain Injury (TBI). The research studies provided evidence that exosomes can serve as a “liquid biopsy” to diagnose neurologic conditions. While exosomes from the central nervous system have previously been identified in the cerebrospinal fluid, the Aethlon-ESI study identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein in the peripheral circulation of affected individuals. The discoveries provide a basis for an exosome-based platform that could enable the simultaneous identification of multiple brain specific markers that are transported across the blood-brain barrier and into the circulatory system.
CTE is a progressive degenerative disease, which at present can only be definitively diagnosed postmortem. CTE has been most commonly found at autopsy in former professional football players and has also been demonstrated to be prevalent in soldiers exposed to blast injury. The hallmark of CTE is the accumulation of tau, an abnormal protein that strangles brains cells in areas that control memory, emotions and other functions. TBI or repetitive brain trauma, including concussions and sub-concussive blows to the head contribute to the onset of CTE.
AD is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death. Beta-amyloid plaques and neurofibrillary tangles have long been recognized as a common pathologic hallmark of AD. In 2010, it was estimated that 36 million people worldwide were living with AD.
Article regarding the latest AEMD news release:
Breakthroughs on the Horizon for CTE and Other Neurodegenerative Diseases
Whitefish MT / March 13, 2014 / The quest to address long-term neurodegenerative problems associated with traumatic brain injury (TBI) and concussions has received plenty of attention recently, in part because of high profile athletes raising awareness and also because of some breakthrough research by Boston University and the University of California at Los Angeles. With any advancement come arguments on both sides of the debate about the accuracy of statements without extensive clinical research, and the sobering reality is that there still are no reliable treatments for diseases like Alzheimer’s disease and chronic traumatic encephalopathy (CTE). All scientific posturing and argumentative rhetoric aside, the fact that companies are making strides in diagnostics and more resources are being devoted to these areas of tremendous unmet medical need are reason for optimism as there are new paths being carved in the evolution of new treatments.
In the public domain, the majority of companies steer clear of neurological conditions because of the elusive nature of answers and the often non-linear progression of these diseases that can make research extremely challenging. The other side of that coin is that successful research can reap tremendous returns from both corporate and humanitarian perspectives. Companies like Neuralstem, Inc. (NYSE MKT: CUR) and Aethlon Medical, Inc. (AEMD) are not shying away from the challenge and appear to be making substantive progress.
Neuralstem’s lead drug candidate, a neural stem cell product called NSI-566, is a key driver for the company. It is in a phase 2 trial for Amyotrophic Lateral Sclerosis (ALS, or “Lou Gehrig’s Disease), a disease where the progressive degeneration of motor neurons erodes communication between the brain, spinal cord and muscles, inevitably leading to death. Neuralstem is seeking a “Breakthrough Therapy” designation from the FDA for NSI-566 for ALS.
More precise to this article’s topic, Neuralstem has NSI-189, a small molecule that in November finished a phase 1b trial in patients with major depressive disorder (MDD) and is currently in the midst of a comprehensive data review expected to run through the second quarter. The drug is being developed with the understanding that MDD is no longer believed to be strictly a condition of brain chemistry, but also a physiology, including reduced hippocampal volume. Early research has shown NSI-189 to increase volume of the hippocampus (a home for neural stem cells that is known to atrophy in depression) by up to 20 percent, lending to the hypothesis that stimulating the genesis of new neurons in the hippocampus could treat depression with a different approach than the commonly used selective serotonin reuptake inhibitors. The company is also researching the molecule’s effect on conditions like TBI, Alzheimer’s and Post-Traumatic Stress Disorder.
This physiological approach has captured the attention of the National Football League Alumni Association. Neuralstem and the NFLAA are working together on an initiative to develop NSI-189 as a new therapeutic to treat NFL alumni members suffering from traumatic brain injuries. Little development details have been disclosed, but as the data from the phase 1b trial for MDD is analyzed, it could lead to a significant step forward in TBI research at Neuralstem.
Aethlon Medical’s Adaptive Dialysis-like Affinity Platform Technology, or ADAPT for short, is the foundation for their flagship product, called the Hemopurifier®, an extracorporeal filtration device that has been shown to selectively and rapidly remove a wide array of viral pathogens, including HIV, and tumor-secreted exosomes from the circulatory system. The company is furthest along with Hepatitis C research. Aethlon disclosed late in February that it has partnered with contract research organization DaVita Clinical Research, a subsidiary of DaVita HealthCare Partners, to provide clinical management services to support additional upcoming clinical trials of the Hemopurifier in end-stage renal disease patients infected with Hepatitis C virus.
Aethlon’s medical device technology is complemented by the exosome expertise of its subsidiary Exosome Sciences Inc. From a broad perspective, research of exosomes, nano-size extracellular vesicles secreted by most every somatic cell and found in bodily fluids, is a rapidly emerging science that leading institutions, such as MD Anderson, have suggested could lead to revolutionary diagnostic tests. While MD Anderson is focused on oncology applications, recent discoveries indicate that exosomes could play a key role in diagnosing, and perhaps treating, degenerative brain conditions.
Aethlon and Exosome Sciences have recently made a potential breakthrough by successfully isolating brain-specific biomarkers in the blood that are associated with a variety of neurodegenerative disorders. Because exosomes can pass through the blood/brain barrier, the microscopic cargo haulers can carry vital information about neurodegenerative conditions happening in the brain. The companies’ research identified exosomes carrying brain-specific markers, including tau, beta-amyloid and other proteins. Tau is of particular interest in CTE research as the accumulation of tau is a hallmark of CTE, a disease often identified in soldiers exposed to blast injury and attributed to suicides of high-profile athletes Junior Seau, Dave Duerson and Andre Waters that can only be officially diagnosed in an autopsy.
The potential to conduct a simple blood test to identify proteins that could implicate a condition like CTE or dementia at an early stage presents an opportunity for a new dynamic to identify and manage life-threatening and debilitating diseases. It also opens the door for innovative approaches as cornerstones to a new paradigm of research. This sort of research takes time, there is no denying that, but thanks to the efforts of organizations like Boston University and UCLA, funding support from the National Institute of Health, the National Football League and General Electric (GE) and the pioneering efforts of companies like Neuralstem and Aethlon Medical, it’s moving faster than ever before.
Great stuff Robert! Thanks for keeping me up to date. AEMD is still one of my favorite stocks. Have great hope for them and bought some more today!
CTSO seems to slow down a bit. I do hope Dr. KSS has made a mistake about them.
Must admit that my confidence in them is not as strong as it has been. But the truth of the matter is that all investments at that level specifically in the biotech sector are high risk. I do keep all my fingers crossed…keep up the good work!!
CTSO is an interesting stock. It’s gone down quite a bit in the last couple of weeks due to dilution and reverse-split fears. I hope there’s some good news coming out of the symposium in Brussels since we haven’t heard anything about Cytosorb sales numbers in awhile. Hope Dr. Chen figures out a way to ramp up sales in Europe and India until US trials are under way…
Company just released an update, things looking pretty good to me:
MONMOUTH JUNCTION, N.J., March 31, 2014 /PRNewswire/ — CytoSorbents Corporation (CTSO), a critical care immunotherapy company using blood purification to treat life-threatening illnesses in the intensive care unit, provides an operational summary and financial results for the fiscal year ending December 31, 2013.
Q1 2014 CytoSorb® product revenue guidance in the range of $530,000 – $570,000 represents more than 60% of total 2013 CytoSorb® revenues
Highlights for the Year Ending December 31, 2013
Total revenue for the year was $2.4 million, as compared to total revenue for 2013 of $1.3 million
Achieved ~$822,000 in CytoSorb® cytokine filter sales in the first full year of commercialization, an increase of 442% over 2012 CytoSorb® product revenue.
Product gross margins were approximately 61% for the year ended December 31, 2013
CytoSorb® sales have been accelerating; sales for the fourth quarter of 2013 were approximately $314,000, an increase of 54 percent over the third quarter of 2013. An additional $37,000 in CytoSorb® orders were invoiced in Q4 2013, but due to common freight carrier pick-up delays, could not be recognized as revenue during the quarter
Grant revenue for 2013 was approximately $1.6 million, up from $1.2 million in 2012
Announced a strategic partnership with BioCon, India’s largest biotechnology company, initially for exclusive distributorship of CytoSorb® in India and select emerging countries
Established agreements with distributors in the United Kingdom, Ireland, the Netherlands, Russia, and Turkey
Ended the year with more than 100 key opinion leaders in critical care medicine and other specialties who are either currently using or planning to use CytoSorb®, with more than 30 new investigator-initiated studies being planned, many of which are enrolling patients
Held the first CytoSorb® Users Meeting at the DIVI 2013 Conference in Leipzig, Germany in December 2013. A short video summary of the meeting can be found here:
https://www.youtube.com/watch?v=98FuPhIvF0Y&feature=youtu.be
The U.S. Air Force announced funding of a 30 patient, randomized controlled human pilot study in the United States amongst trauma patients with rhabdomyolysis. The FDA and institutional ethics committees have approved the trial, which has now commenced
Established a world-class Trauma Advisory Board to assist with international trauma and burn studies
The National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (“NIH”), awarded the Company a Phase I SBIR (Small Business Innovation Research) contract to further advance its HemoDefend™ blood purification technology for packed red blood cell (pRBC) transfusions
Continued steady progress on our DARPA and U.S. Army programs in sepsis, burn injury and trauma
Reported interim data from the first arm of the Sepsis Dosing study demonstrating that continuous treatment (replacing the CytoSorb® cartridge every 24 hours) over 7 days was safe, with cytokine reduction occurring throughout the 24 hour period. Overall 28-day mortality was similar to that seen in the treatment arm of the European Sepsis Trial in a preliminary analysis.
Dr. Phillip Chan, CEO of CytoSorbents, stated, “We are an emerging leader in critical care immunotherapy where we are working to reduce deadly inflammation to prevent or treat organ failure. This is a $20 billion worldwide total addressable market and with CytoSorb®, we are one of the few companies with an approved product in the European Union targeting this opportunity.”
“2013 was an outstanding year for the Company, as outlined in our 2013 Shareholder Letter. I would encourage shareholders to read this letter if they have not already done so,” Dr. Chan continued. “During our first full year of product commercialization, we experienced strong support for the CytoSorb® therapy and continue to see solid momentum in 2014, as evidenced by our Q1 2014 guidance. We believe our recent fundraise of $10.2 million will help to further catalyze the growth of our business, with proceeds focused on CytoSorb® sales and clinical studies.”
Excellent! I am long CTSO!!! Thanks Robert! It seems to have worked, somehow I am on the mailing list of CTSO, although I have no idea how i did it. All the Best…!!!
Zacks research just published this on CTSO:
http://origin.library.constantcontact.com/download/get/file/1116185133622-4/Zacks_Q4_2013_update.PDF
Outlook:
CytoSorb was CE Marked in March 2011 and subsequently
commenced its initial commercialization. Initial focus on building
awareness appears to be paying off. CTSO now generating clinical
outcomes data which is just starting to be used to accelerate
adoption and utilization. Mgmt outlined a multi-point plan on Q4 call
to use recent cash raise to further accelerate sales as well as
generate additional clinical data and build awareness. CTSO now
expects to pursue cardiac surgery indication in the U.S. as this may
provide the lowest cost, easiest and fastest route to the U.S.
market. Cardiac surgery indication has driven substantial interest
overseas with successful outcomes. Gov’t contracts/grants that
CTSO continues to score should benefit near-term revenue and
cash flow as well as also aid their awareness-building efforts, further
increase visibility and credibility of the technology, and potentially
expand the menu of potential applications of the device. Interest in
and use of CytoSorb from key opinion leaders continues to
increase.CytoSorb was CE Marked in March 2011 and subsequently
commenced its initial commercialization. Initial focus on building
awareness appears to be paying off. CTSO now generating clinical
outcomes data which is just starting to be used to accelerate
adoption and utilization. Mgmt outlined a multi-point plan on Q4 call
to use recent cash raise to further accelerate sales as well as
generate additional clinical data and build awareness. CTSO now
expects to pursue cardiac surgery indication in the U.S. as this may
provide the lowest cost, easiest and fastest route to the U.S.
market. Cardiac surgery indication has driven substantial interest
overseas with successful outcomes. Gov’t contracts/grants that
CTSO continues to score should benefit near-term revenue and
cash flow as well as also aid their awareness-building efforts, further
increase visibility and credibility of the technology, and potentially
expand the menu of potential applications of the device. Interest in
and use of CytoSorb from key opinion leaders continues to
increase.
The presentation and official transcript from the 2013 Earnings Report for CTSO from Monday, March 31, 2014 here:
https://origin.library.constantcontact.com/doc200/1116185133622/doc/wBgz42N6eX3tbg4Y.pdf
https://origin.library.constantcontact.com/doc200/1116185133622/doc/3l0lyaOI7c8SoQhV.pdf
Press release today from Aethlon:
Aethlon Medical (AEMD) Note: U.S. Clinical Progression
SAN DIEGO, April 9, 2014 /PRNewswire/ — Aethlon Medical, Inc. (OTCQB: AEMD), today released the following note authored by its Chairman and CEO, Jim Joyce.
Aethlon Hemopurifier
In the coming months, we plan to initiate the first FDA approved study of Hemopurifier® therapy in the United States. Historically, U.S. clinical progression of extracorporeal devices directed toward a single disease indication has been a proven model for value creation.
Our clinical objectives are a bit more ambitious as we aim to navigate Hemopurifier® therapy into both cancer and infectious disease indications. Yes, we plan to file an investigational device exemption (IDE) to treat cancer later this year. We are also investigating Emergency Use Authorization (EUA) opportunities based on our broad-spectrum bioterror and pandemic threat data and have begun to explore Humanitarian Use Device (HUD) pathways for orphan conditions that affect fewer than 4,000 individuals in the U.S. each year.
To support the breadth of our long-term therapeutic vision, we often encounter challenging decisions. As an example, we recently disclosed a clinical relationship with DaVita Clinical Research, which required a lengthy process to establish and thus contributed to delay the initiation of our hepatitis c virus (HCV) feasibility study. However, the resulting relationship transitioned our potential clinical footprint from a single-site institute to an institute with more than 250 clinical sites to support long-term regulatory objectives.
Since crossing the threshold of having the FDA clear our candidate therapy for human studies, our therapeutic focus has been honed toward clinical progression to support future registration of Hemopurifier® therapy in the United States. The protocol of our forthcoming feasibility study calls for the enrollment of ten HCV-infected end-stage renal disease (ESRD) patients who have not received HCV drug therapy for at least 30 days. The protocol includes a control phase which consists of three consecutive standard dialysis treatments during week one followed by the inclusion of our Hemopurifier® for a total of six treatments administered during weeks two and three. The rate of adverse events observed during the Hemopurifier® treatment phase will be compared to the rate experienced during the control phase. Per-treatment changes of viral load will be observed through PCR analysis and we will also quantitate HCV viral copies captured within the Hemopurifier® during each treatment session. Successful completion of the feasibility study will set the stage for us to conduct pivotal efficacy studies required for Hemopurifier® market clearance. The study will also contribute data toward the human safety challenge requirement to advance the Hemopurifier® as a broad-spectrum countermeasure against viral bioterror and pandemic threats, whose lethality do not allow for the administration of clinical efficacy studies. Based on our experience conducting a similar protocol overseas, we are cautiously optimistic.
In closing, it is our sincere hope to reward shareholders whose support never wavered, even in the face of material setbacks and the clinical uncertainty of whether FDA would permit Hemopurifier® studies in the United States. As a result of this support, we have an opportunity to advance our therapeutic platform into a wide-range of life-threatening disease conditions.