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.