CytoTools AG (DE000A0KFRJ1/T5O) of Germany and its Indian marketing partner, Centaur Pharmaceuticals, expect to receive regulatory clearance in the current quarter in India for lead product, DermaPro, to treat diabetic foot wounds, thus paving the way to a market launch in early 2015.
“Our Phase 3 results in India confirm previous studies and represent a breakthrough in this disabling disorder, for which there is no effective treatment, and if untreated, can lead to infection and amputation,” CEO Dr. Mark-Andre Freyberg says in an interview with BioTuesdays.com.
“We also have additional clinical evidence that DermaPro has the potential to be used for all chronic wounds, including pressure and leg ulcers,” he adds.
DermaPro could be the first significant biotech product discovered, developed and brought to market by a German biotech company. Other products from the German biotech sector have either been in-licensed or sold before reaching market.
Dr. Freyberg explains that DermaPro is a liquid that is applied to a wet bandage to cover slow-healing open wounds. The product stimulates increased growth of cells involved in wound healing along with antiseptic properties to inhibit additional infections. “We have seen positive results of wound healing in four-to-six weeks,” he contends.
Founded in 2000, CytoTools is a holding company that operates two subsidiaries: DermaTools Biotech, which is involved in dermatology and urology; and CytoPharma, which is working in the areas of cardiovascular diseases and cancer.
Dr. Freyberg says CytoTools owns approximately 57% of DermaTools and approximately 42% of CytoPharma. Each subsidiary conducts its own R&D, clinical studies and financing.
In Phase 3 testing in India, with 310 patients suffering from diabetic gangrene conditions, DermaPro achieved 92% healing and 76% complete wound closure over a 10-week treatment period.
In Phase 2 studies in Germany and Europe, which were conducted independently from the Indian trials, DermaPro achieved similar rates of wound healing, Dr. Freyberg points out. No adverse events have been reported with DermaPro.
DermaPro is also in a European Phase 3 study, treating patients with diabetic food wounds, and in a Phase 2/3 study in Europe, treating patients with venous leg ulcers.
Interim results from160 patients in the European Phase 3 trial are expected before the end of 2014, with the study to be completed in the second half of 2015.
Dr. Freyberg says several American drug companies have been interested in DermaPro for a number of years and “we will supply the interim data from the European Phase 3 study to potential partners for evaluation.”
CytoTools’ would consider a licensing deal for DermaPro or an outright sale of its DermaTools Biotech, he adds.
CytoTools has retained a U.S. investment banker to facilitate a transaction. “We would be happy if an American company would take it over, but we are also in talks with different European companies,” he says. “We hope to reach a deal in 2015.”
Dr. Freyberg points out that DermaPro’s production facilities would be part of the package for a potential buyer, so a buyer would also need to fulfill the contracts DermaTools has with Centaur and would need to deliver DermaPro to Centaur for the Indian market.
A variant of DermaPro, DermaPro Pep 04, for the treatment of large surface area burn wounds, is in early clinical studies. DermaPro Pep04 is designed to ensure that connective tissue cells are protected from programmed cell death. Dr. Freyberg notes that early research has shown an up to fourfold increase in healing.
Some 19 patents and 12 patent applications in the U.S., Europe, Africa, India and Japan protect the technology until 2024-2025.
The market potential for an effective treatment of leg and foot wounds is huge. Worldwide, some 95 million people suffer from chronic wounds. In addition, there are currently more than 380 million diabetics worldwide, of which 20% could develop foot ulcers and wounds.
CytoTools plans to use proceeds from any spinoff of its dermatology assets and revenue from DermaPro sales in India next year to move its pipeline forward.
A variant of the active compound from DermaPro is also used in the company’s Utisept medical device for flushing the bladder in urinary tract infections. It consists of an applicator that is used in combination with the Utisept disinfecting rinsing solution to reduce, quickly and effectively, a high initial bacterial load in an infected cystitis bladder.
CardioClean is a line of preclinical cardiovascular agents from CytoPharma for the treatment of restenosis and carotis-stenosis, or occlusion of blood vessels. The HMW and LMW drugs are designed to protect cells that line blood vessels, so that a re-closure of the blood vessel can be prevented after the stenosis has been treated.
Dr. Freyberg says CytoPharma is looking for a U.S. partner with expertise in cardiovascular disorders to help develop LMW Ox, a low-molecular agent for arteriosclerosis therapy. LMW Ox is characterized by an improved degree of bioavailability and is being designed as an oral therapy.
CytoPharma also is developing a new diagnostic system in parallel to the active ingredients of the CardioClean series to detect the onset of arteriosclerotic changes. “As a result, treatment of arteriosclerosis can start earlier than with current diagnostic means,” Dr. Freyberg contends.