Cytomedix has reported positive data from a clinical trial of its wound care therapy in Japan — and a major stock sale involving a 15.3 percent stake in the Gaithersburg biotech.
Results from the study, which involves 39 “severely compromised” patients with a range of serious wounds involving diabetes mellitus and other conditions, were published in this month’s edition of Ostomy Wound Management.
The patients, who had abscesses, ulcers, gangrene and other ailments, were treated with Cytomedix’s AutoloGel, a platelet-rich-plasma gel. Prior to treatment with AutoloGel, no wounds healed during a 75-day “run-in period,” during which standard of care and other treatments were administered. Some wounds worsened.
Following an average of 6.1 treatments with the candidate, 83 percent of the wounds healed in an average of 145.2 days, according to the study.
The results show “that patients with chronic diabetic wounds and compromised arterial flow can heal and avoid limb amputation with AutoloGel treatment,” CEO Martin P. Rosendale said in a statement.
“These data support and validate previous studies showing that AutoloGel significantly and reliably improves the rate of complete healing, speed and progress to healing, and quality of life as compared with standard wound care,” he said. “The complexity and comorbidities associated with these wounds would have excluded them from any randomized controlled trial making this real world comparison study even more compelling.”
The data “strongly support our case for a positive National Coverage Determination from the Centers for Medicare and Medicaid Services to cover autologous PRP gel” to improve care and lower costs, Rosendale said.
According to the study, 23.7 million people in the U.S. have diabetes mellitus, a chronic form of the disease that involves insulin deficiency. Overall, 25.8 million Americans have diabetes, according to the American Diabetes Association. Diabetes mellitus is also widespread in Japan, where 10.7 million people, or 11.2 percent of that nation’s population, have the condition. About 90 million people in China have the disease.
Also this week, the holding company of a North Carolina biotech that Cytomedix acquired in February has bought a 15.3 percent stake in the publicly held Gaithersburg company for $20.2 million, according to a filing with the Securities and Exchange Commission.
Cytomedix paid about $16 million in stock for the Durham company, which is developing regenerative cell therapies for stroke and other conditions. Aldagen now operates as a subsidiary of Cytomedix.
The deal’s total consideration could reach $40 million, if certain milestones are achieved. As part of the transaction, Aldagen investors bought $5 million of Cytomedix common stock in a private placement.
In other Maryland bioscience industry news:
Northwest Biotherapeutics, the Bethesda biotech that’s developing a therapeutic brain cancer vaccine, has a new collaborator: King's Health Partners of London.
Under the agreement, King’s College London will manufacture DCVax for treating patients at King's College Hospital NHS Foundation Trust as part of Northwest’s 240-patient clinical trial being conducted at more than 30 sites in the U.S. Both the college and trust are part of King's Health Partners.
Besides participating in the trial, the hospital will treat patients on a “compassionate use basis,” for those who don’t meet all the criteria for the trial but might benefit from the treatment, according to a Northwest statement.
King's has a certified facility and personnel to produce the candidate, and permits have been secured, the company said. Production will be supervised by the company’s contract manufacturer, Cognate BioServices of Hanover.
"This partnership can help accelerate our brain cancer clinical trials, and also help extend lives through compassionate use treatments for other patients while the trials are ongoing,” Northwest CEO Linda Powers said in the statement. “This partnership also expands our manufacturing capacity and flexibility in a highly cost effective way — a great arrangement both for patients and for our programs."
Ameritox, a Baltimore company that specializes in pain medication monitoring, has licensed an experimental blood test designed to detect biomarkers for major depressive disorder from Ridge Diagnostics of San Diego.
Ameritox will make an undisclosed equity investment in Ridge and conduct the next stage of the test’s development, according to a joint statement from the privately held companies.
The test, called MDDScore, could help physicians diagnose the disorder, select the proper treatment and cut costs, according to the companies. It measures 10 biomarker levels associated with factors such as inflammation, development and maintenance of neurons and interaction between brain structures involved with stress response and other biological functions. It was “highly accurate” in a recent peer-reviewed study involving 70 adult patients.
“Biomarkers are an important emerging scientific tool to better understanding illness, and may enable health professionals to improve the accuracy of diagnosis and help match the right treatment to the right patient,” Ancelmo Lopes, CEO of Ameritox, said in the statement. “Personalizing care offers the best use for precious health care resources. … We are excited to launch clinical trials to evaluate the utility of MDDScore in primary care and pain medicine settings."
RegeneRx Biopharmaceuticals reported that it received an issued patent in Mexico and allowances of three additional patent applications in Mexico and Israel.
The new Mexican patent involves uses of the Rockville company’s thymosin beta 4 compound to treat or prevent biological or immunological responses to reactive chemical or biological agents, or toxins, according to company information. Three other applications in Mexico cover uses of the compound to treat elevated intraocular pressure and dry eye, congestive heart failure and damage resulting from increases in blood flow, such as reperfusion injury, associated with opening blocked arteries.
The Israeli patent covers use in various neuromuscular conditions. The patents are to expire in 2024-26.
Cerecor of Baltimore reported that its investigational new drug application for its cough lozenges has cleared the Food and Drug Administration’s 30-day deliberation period.
The company plans to launch a phase 2 study of the treatment in subjects with upper respiratory tract infections.
"Acceptance by the FDA of this application and the advancement of FP01 to clinical testing are important milestones for the Company and key steps along the path to commercialize a treatment for acute and chronic cough,” CEO Blake Paterson said in a statement. “The data we plan to generate from the initial Phase II study will educate us about the effect size of FP01 as an antitussive, providing for future studies."