CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and absorption. CytoSorbents is currently selling its flagship product, CytoSorb®, in Germany with availability in other European countries.
Acute pancreatitis is the inflammation of the pancreas that results in the local release of digestive enzymes and chemicals that cause severe inflammation, necrosis and hemorrhage of the pancreas and local tissues. Approximately 210,000 people in the U.S. are hospitalized each year with acute pancreatitis with roughly 20% requiring ICU care. Overall ICU mortality of severe acute pancreatitis approaches 20%.
Acute pancreatitis is caused most frequently by a blockage of the pancreatic duct or biliary duct with gallstones, cancer, or from excessive alcohol use. Severe acute pancreatitis is characterized by severe pain, inflammation, and edema in the abdominal cavity, as well as progressive systemic inflammation that can lead to multiple organ failure. High levels of cytokines and digestive enzymes can be found in the blood and are correlated to organ dysfunction.
Aside from trying to unclog the duct with endoscopic techniques, there is little that can be done except for bowel rest, aggressive hydration, antibiotics when indicated, and pain control. However, CytoSorb® may potentially improve the outcome of severe acute pancreatitis by removing a diverse set of toxins from blood.
Some recent data from a report in the June 2012 issue of the Journal of Leukocyte Biology demonstrates that one cytokine in particular, IL-6, is associated with worsened outcomes in mice models of pancreatitis. This report "describes experiments in lean and obese mice that identify the presence of high IL-6 as one of the reasons why the disease is more devastating in obese people."
John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology, stated,
"There is an increasing awareness that obesity and inflammation are connected. Not only does this new report demonstrate an important set of interactions between obesity, pancreatitis, and inflammation, but it also identifies the inflammatory pathway, IL-6, which could represent an important new therapeutic target in these settings."Read more here.
Amongst its many potential benefits in severe acute pancreatitis, CytoSorb® was clinically proven to reduce IL-6 in critically-ill patients by approximately 50%, and other key cytokines by 30-50%, in CytoSorbents’ European Sepsis Trial that finished last year. CytoSorbents believes severe acute pancreatitis is just one of many life-threatening illnesses that it may be beneficial in.
Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
In a Wall Street Journal article, Timothy W. Martin writes that "OxyContin is set to go off patent next year, but the maker of the powerful and heavily abused prescription painkiller is trying to extend its exclusive rights to the drug, arguing that a new version it spent $100 million to develop might substantially curtail abuse. Whether Purdue Pharma LP will be able to protect its reformulated OxyContin will be decided by the courts."
Purdue Pharma LP argues that its new version of OxyContin, which has patent protection until 2025, is more abuse-resistent than the original formulation, and "generic-drug makers should be prevented from producing the original version of OxyContin." Manufacturers of generic drugs, on the other hand, "say Purdue Pharma is just trying to protect a lucrative market for itself, and that they can make their own abuse-deterrent formulations of the drug." Read the full article here.
Commenting on the article, Intellipharmaceutics CEO Dr. Isa Odidi stated,
"We expect that any 'generic' of OxyContin will have to have an abuse deterrent technology; this would result in a NDA or NDA 505(b)(2) regulatory path. A pure generic to the original version of OxyContin will not be available; this would be the ANDA regulatory path. The new version of OxyContin from Purdue has additional patent protection to 2025, therefore a generic to this version will be challenging as they have to claim that the change will not merit extending Purdue's patent protection.
Our lead non-generic product under development is Rexista(tm) oxycodone hydrochloride, intended as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. Rexista(tm) is a unique dosage form designed to be a deterrent to some of the well-documented abuses associated with some currently marketed controlled-release oxycodone products. This includes abuse of these drugs by nasal inhalation when crushed or powdered, or by injection when combined with solvents. Rexista(tm) oxycodone is also designed to resist release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs."
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three and six months ended May 31, 2012. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
The Company recorded a net loss for the three months ended May 31, 2012 of $1.4 million, or $0.08 per common share, compared with a net loss of $2.0 million, or $0.12 per common share for the three months ended May 31, 2011. The net loss for the six months ended May 31, 2012 was $3.3 million, or $0.20 per common share, compared with a net loss of $4.7 million, or $0.33 per common share for the six months ended May 31, 2011. The Company's reduced net loss in the three months ended May 31, 2012, can be attributed to a reduction in the fair value adjustment of derivative liability of $0.8 million and the timing of certain research and development activities. After adjusting for the fair value adjustment of derivative liability, the loss for the three months ended May 31, 2012 was lower by $0.3 million and is discussed below.
Loss from operations for the three months ended May 31, 2012 was $2.0 million compared with $2.4 million for the three months ended May 31, 2011. Research and development expense for the three months ended May 31, 2012 decreased to $1.1 million compared to $1.4 million in the three months ended May 31, 2011. After adjusting for stock-based compensation expense, expenditures for research and development for the three months ended May 31, 2012 were lower by $0.4 million. Selling, general and administrative expenses for the three months ended May 31, 2012 decreased to $0.8 million versus $0.9 million in the prior period. After adjusting for stock-based compensation expense, expenditures for selling, general and administrative expenses for the three months ended May 31, 2012 were lower by $0.2 million.
At May 31, 2012, Intellipharmaceutics' (IPCI) cash and cash equivalents totaled $4.9 million, compared with $2.6 million at February 29, 2012. The increase in cash during the three months ended May 31, 2012 is mainly due to the Company's registered direct common share offering for gross proceeds of $5 million completed on March 14, 2012.
For the three months ended May 31, 2012 net cash flows used in operating activities was effectively unchanged at $1.8 million, as compared to net cash flows used in operating activities for the three months ended May 31, 2011 of $1.9 million. For the three months ended May 31, 2012 net cash flows from financing activities of $4.5 million related mainly to the Company's registered direct common share offering for gross proceeds of $5 million.
Corporate Update
On March 15, 2012, we closed a registered direct common share offering for gross proceeds of $5 million. The Company sold an aggregate of 1,818,182 shares to U.S. institutional investors at a price of $2.75 per share. After placement agent fees and estimated offering expenses, the Company received net proceeds from the offering of approximately $4.2 million. Intellipharmaceutics is using the net proceeds to file additional abbreviated new drug applications ("ANDAs") with the Food and Drug Administration ("FDA"), to advance clinical trials for its abuse resistant Rexista" technology and/or other New Drug Application ("NDA") 505(b)(2) opportunities, to establish additional partnerships, and for working capital, research, product development and general corporate purposes.
On May 1, 2012, the Company held a pre-Investigational New Drug ("pre-IND") meeting with the FDA to discuss our Rexista" oxycodone development plan. A panel of the FDA'sCenter for Drug Evaluation and Research clarified the Company's path going forward for its Rexista" abuse-deterrent oxycodone development plan. Intellipharmaceutics will now advance toward the next goals of its Rexista" program, namely the manufacture of clinical batches of Rexista" abuse-deterrent oxycodone product candidate under current good manufacturing practice ("cGMP") conditions and the commencement of definitive Phase I clinical studies. This follows from the previous proof-of-concept Phase I clinical study completed on a pilot laboratory batch, which yielded positive results. There can be no assurances as to whether or when the FDA will approve any Intellipharmaceutics' application.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix" technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including six ANDAs under review by the FDA, in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes, pain and infection.
Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
With the FDA informing Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis this certainly bodes well for Intellipharmaceutics’ generic Focalin XR for ADHD. IPCI has a strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR who has publicly stated that they have a date certain launch of October 2012, assuming FDA approval on or before this date. IPCI has publicly stated that obtaining Focalin XR approval is a 2012 goal.
According to the Shire press release:
"The FDA’s response requires that all abbreviated new drug applications ( ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products."
Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs.
Today Markus Aarnio posted an update Ventrus @ Seeking Alpha:
"I wrote the article titled "4 Reasons To Buy Ventrus Biosciences" on May 21st. On June 25 Ventrus Biosciences (VTUS) reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints.
While the company intends to analyze the totality of its Phase 3 data further, it believes that current resources would be better allocated toward the planned completion of its VEN 307 (diltiazem cream) development program in anal fissures and the beginning of further development of VEN 308 (topical phenylephrine) in fecal incontinence. Consequently, Ventrus has no immediate plans to continue development of VEN 309, resulting in a reduction in expenses.
Conclusion - I believe the stock could trade at $8-$10 range in the best case scenario after VEN-307 approval sometime in 2014. I do not expect any major near term catalysts from the company before late 2013."
Jeffrey B. Davis is the President and Chief Executive Officer of Access Pharmaceuticals, Inc. (OTCBB: ACCP), which is a biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com). Today the company released the following press release:
MUGARD DEMONSTRATES STATISTICALLY SIGNIFICANT REDUCTION IN PAIN ASSOCIATED
WITH ORAL MUCOSITIS, DELAY TO ONSET OF ORAL MUCOSITIS, AND REDUCTIONS IN WEIGHT LOSS AND THE USE OF OPIOID PAIN MEDICATION
First-in-Kind Trial Design For Medical Device Sets New Standard For Evaluation of Mucositis Treatment Regimens; Strength of Clinical, Quality of Life and Pharmacoeconomic Data Suggests Use in All Patients at Risk For Mucositis
First Oral Mucositis Treatment Option to Provide Significant Clinical Benefit to Head and Neck Cancer Patients Suffering with Oral Mucositis Side Effect
The following is an interview with Jeff Davis of ACCP by Mike Sweeney of Daily Dose Equities.
Sweeney: Some exciting new data on MuGard was presented at the MASCC meeting today. First, can you explain a little about what MuGard is, and what condition does it treat?
Davis: Sure. MuGard is an innovative, patented medical device that is FDA approved to treat ulcers and wounds in the oral cavity, including a very debilitating side effect of many cancer treatments called oral mucositis. Oral mucositis is basically a break-down, or ulceration, of the skin in your mouth, tongue and throat. It results in extremely painful ulcers or lesions, like large canker sores, that cause a lot of other clinical and “quality of life” issues, such as infections, bleeding, inability to speak, drink, eat and swallow, and in the worst incidences, the necessity to reduce, change or stop one’s underlying cancer treatment. It’s estimated that there are at least 400,000 diagnosed cases of oral mucositis every year in the US alone, and most think it’s very under-diagnosed because there have been very few, if any, means to prevent it or treat it. Many oncologists tell us that the oral mucositis side effect is the biggest problem in oncology today, after the actual killing of the cancer, of course.
Sweeney: What is MASCC, and what MuGard data is being presented at the symposium?
Davis: MASCC stands for the Multi-national Association for Supportive Care in Cancer, which is the global organization that is dedicated to research and education in the supportive care of patients with cancer. They hold an annual conference in June, together with the International Society of Oral Oncology (ISOO), and this year’s event is going on in New York City, June 28th through the 30th. From our perspective, it’s the opportunity to showcase MuGard with all the leading thought leaders and researchers in oral mucositis space.
Data from the first seventy 70 patients enrolled in the MuGard clinical trial is being presented, in both oral and poster formats, by one of the principal investigators in the trial, Dr. Ron R. Allison from Carolina Radiation Medicine in Greenville, North Carolina. Again, we’re evaluating head and neck cancer patients using MuGard or Placebo rinse during their six or seven weeks of chemoradiation therapy. The data, simply put, is the best that has ever been seen in head and neck cancer patients – the patients which are the very hardest to treat. A summary of the data is as follows:
MuGard patients experienced a statistically significant reduction in mouth and throat soreness – the primary clinical endpoint – versus the placebo arm. The p-value was 0.041. This is a very significant clinical outcome, particularly when the placebo arm used significantly more opioid painkiller medication. To be clear, the MuGard arm had a statistically significant reduction in pain relative to the placebo arm, even though the placebo arm used more opioid medication. It’s important to reiterate that MuGard has no pain reliever medication in it, so we believe the reduction in pain is directly attributed to the protective properties discussed earlier.
MuGard patients had delayed onset and longer time to first occurrence of oral mucositis, as measured in both treatment days and amount of radiation received, and both of these outcomes were statistically significant (p-values of 0.020 and 0.022 respectively). It is clinically important to highlight that the use of MuGard will delay the onset of mucositis, effectively pushing the effects and impact out mucositis out in time.
MuGard patients had a significant reduction in the number of days of opioid use relative to the placebo arm (18 days versus 8 days, with a p-value of 0.035). The reduction in opioid use is very important from quality of life and pharmacoeconomic perspectives (reduced drowsiness, reduced nausea, ability to drive oneself).
Lastly, patients using MuGard lost less weight than the placebo arm. A big problem with these patients is that their mouths and throats get so sore that they stop eating. Obviously, the ability to stay nourished and strong is important. Patients using MuGard lost less weight, which was also statistically significant.
Sweeney: How does MuGard actually work? What is the mechanism of action?
Davis: That’s an excellent question. But to answer it, you have to understand a little about the oral mucositis condition. I call oral mucositis a “degenerative” disease or condition that occurs because of a cascade of contributing factors. First, you have the “insult” to the oral cavity, which is the actual chemotherapy or radiation therapy which damages the oral mucosa. Second, you have a condition called “stomatitis” or inflammation of the oral mucosa; basically the body’s own inflammatory response to the insult, characterized by redness, soreness and swelling that further damages the oral mucosa. And lastly, one typically gets xerostomia – or simply dry mouth – and as a further exacerbating factor, one experiences changes in the composition and concentration of bacteria in the mouth, all of which further weakens the oral mucosa and worsens the oral mucosa. As a “degenerative” disease, we typically recognize that the more radiation and/or chemotherapy one has, the higher the incidence and greater the severity of oral mucositis.
Back to your original question: How does MuGard actually work? Well MuGard provides an innovative, protective barrier to the oral mucosa. One can think of it as a liquid bandage that is safe to swallow. Patients basically swish MuGard around in their mouths, and it provides a protective coating to the oral mucosa, that actually sticks there. We believe MuGard protects the oral mucosa against the “insult” of chemo or radiation; MuGard showed in a clinical trial that patients using MuGard had a reduced inflammatory response; and lastly, MuGard acts as a physical barrier to the bacteria in the mouth that exacerbates the oral mucositis condition – bacteria doesn’t go through MuGard. It’s a patented muco-adhesive polymer gel that protects the mouth against the cascade of damaging factors of oral mucositis. Sweeney: Why did Access run the Phase 4 MuGard clinical trial, if MuGard was already FDA approved?
Davis: There are very few treatment options that have ever shown a significant clinical benefit in oral mucositis, let alone the very worst candidates for oral mucositis which are patients undergoing radiation and chemotherapy for various head and neck cancers. Practically all of these patients get oral mucositis of some severity, and roughly half get severe oral mucositis, meaning Grade 3 or Grade 4.
In mid-2010, Access decided to run a Phase 4 – or post-FDA marketing clearance – trial to get additional definitive data as to the benefits of MuGard in treating oral mucositis. As such, we worked with Dr. Stephen Sonis of Harvard University, Bingham & Women’s Hospital, and the Dana Farber Cancer Institute, a leading authority on the oral mucositis condition, to help us write the clinical trial protocol for the “Gold Standard” clinical trial in oral mucositis. We decided to run the trial in head and neck cancer patients that are undergoing 6 to 7 weeks of radiation therapy with concurrent chemotherapy – this very tough patient group – knowing that if we could show a significant clinical benefit in this patient group, than we could help all patients at risk of oral mucositis, or a much larger potential patient population. To date, there has been no device or drug that has shown any significant clinical benefit in the head and neck cancer population. Sweeney: What does the MuGard Phase 4 trial design look like?
Davis: The MuGard Phase 4 trial is unique and rigorous in its design, and we’ve been commended for it as it wasn’t required from a regulatory perspective – we did it to show patients and caregivers how well it works, and to show payers how it saves money. It’s a prospective, randomized, multi-center- roughly 20 centers, double-blind, placebo-controlled study to evaluate the efficacy of MuGard in controlling symptoms caused by oral mucositis in subjects receiving chemoradiation therapy for the treatment of cancers of the head and neck. We believe this trial design is the first to be used to evaluate a device for an oral mucositis indication and distinguishes Access and MuGard from competing companies and products. In addition to the primary clinical endpoints, which assess MuGard’s efficacy in reducing pain and delaying the onset, or prevent oral mucositis, the protocol provides for a wide range of other endpoints including quality of life and pharmacoeconomic outcomes. Details on the MuGard Phase 4 clinical trial are available at the ClinicalTrials.gov website.
FluoroPharma Medical, Inc. (OTCQB: FPMI) engages in the discovery, development and commercialization of proprietary medical diagnostic imaging products. The company’s initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, amyloid plaque in Alzheimer’s disease and agents for detection of certain types of cancer.
At Seeking Alpha, contributor MissionIR writes that for a developing business to be considered valuable, it needs to "present products that have unique benefits not found elsewhere, providing a decided advantage in the marketplace." He argues that FluoroPharma is such a company, writing that "the products that FluoroPharma is developing have distinct advantages in their ability to highlight critical processes that point to developing cardiovascular disease, sometimes called coronary artery disease (CAD), the country's number one killer, at its earliest stages."
He goes on to elaborate on the company's 3 main products - CardioPET for the assessment of myocardial metabolism, BFPET for the assessment of blood flow for CAD, and VasoPET for the detection of vulnerable plaque in CAD (currently in preclinical development) - as well as their unique advantages.
CytoSorbents Corporation (OTCBB: CTSO)is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption.
At MicroCap MarketPlace, Executive Editor Mike Casson writes that "investors who want real growth in the health care space head to the biotech or medical device sub-sectors. Quite possibly one of the more alluring things about micro-cap biotechnology and medical device firms is that these tiny companies often have cut-and-dry situations." In other words, they do really well or they tank.
Casson believes that CytoSorbents is positioned to be one the companies that growth-hungry investors look for. He writes,
"I think CytoSorbents’ game-changing blood purification technology will revolutionize the way doctors treat life-threatening illnesses in intensive care units and will be a key market driver for the Company...Of course, there are risks with CytoSorbents (this is a development stage company after all) just as there are with most micro-caps, but the key here is the potential rewards seem to far outweigh the risks and the stock probably trades at a valuation that isn’t justifiable, meaning it’s too low."
He goes on to explain 3 additional key investment considerations: CytoSorb's availability in Germany, the Company's strong intellectual property portfolio, and the biggest key of all, the company's management team.
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CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and absorption. CytoSorbents is currently selling its flagship product, CytoSorb®, in Germany with availability in other European countries.
acute pancreatitis, 
