Partnership Opportunity

Debride WH1 Cream for Wound Healing

SUMMARY
Debride WH-1 is a topical therapy that contains triamcinolone acetonide (corticosteroid anti-inflammatory) and lidocaine (anesthetic) as active ingredients. This patent pending drug product represents a fundamentally new combination approach to topical treatment of open wounds such as decubitus or pressure ulcers. The product can be developed as a prescription drug for the treatment of decubitus or pressure ulcers but has potential in other clinical indications including, wounds, burns, mucositis and various skin irritations including rashes and insect bites. The product will potentially have clinical benefits with regard to 1) wound healing, 2) localized pain relief, 3) reduced inflammation and itching and 4) antiseptic action. There is antidotal evidence that the formula is demonstrating good efficacy for diabetic leg and foot ulcers in Israel.

Wound Care Market – Pharmaceutical Market Opportunity
Growth of wound management is linked to the growth of surgical procedures, aging demographics, and higher rates of diabetes in developed countries. Chronic wounds are borne out of vascular disease, venous insufficiency, excessive pressure, and diabetic neuropathy. These are all prevalent within the elderly population who constitute the most rapidly growing segment in developed countries.

• There are approximately 5.2 million pressure ulcers worldwide that require treatment every year. There are another 7.6 venous ulcers and approximately seven million diabetic foot ulcers.
• An estimated six million people suffer from chronic wounds in the United States alone; on average, three million have pressure ulcers, over two million have diabetic ulcers, and over one million suffer from venous stasis ulcers.
• Venous stasis disease and pressure ulcers often afflict the elderly, who account for a disproportionately large share of total global and U.S. health care expenditures.
• Estimates from various sources state that treatments costs associated with diabetic wounds run upwards of $50,000 on average, with successful healing of only about 30% or less. Should the ulcer result in limb amputation, treatment costs increase to approximately $69,000. The American Diabetes Association (“ADA”) has reported in their web-published National Diabetes Fact Sheet that from 2000 to 2001 approximately 82,000 non-traumatic limb amputations were performed each year among people with diabetes. These cost estimates, coupled with the ADA’s amputee figures, imply that over $5.6 billion in U.S. healthcare costs are incurred annually by public and private insurance carriers and healthcare providers for amputations and related costs associated with chronic non-healing diabetic wounds.

Product Formulation
The formulation components were selected to satisfy the special needs for a topical application to an open/chronic wound. During the initial development the first component needed would be some sort of bio-adhesive to hold the medicine to the wound long enough for the active components to have an effect. The second component was the active (a corticosteroid to promote blood circulation) the third component was to add something to relieve the pain long enough to allow treatment without removing the material before it had time to work. The fourth and final component, Mineral oil, was added to try to provide a temporary barrier from the water and also to keep the area moist. It has since been learned that this particular formulation has three of the components having multiple roles. Such as the mineral oil is used as a carrier, moisturizer, and for water displacement. The principal activity of lidocaine is as a local anesthetic, however this active ingredient also functions as an antiseptic and preservative system. The bioadhesive used is designed for aqueous systems and is insoluble in the mineral oil. Hence when applied to a wet surface acts not only as an adhesive but absorbs the liquid material in the ulcerated area providing intimate contact to the surface without dilution of concentration of the soluble components such as the corticosteroid. The bioadhesive is also acting as a sponge to dilute the concentrations of infectious components and endotoxins in the immediate area as well as a debriding agent.

Product Development
The cream formula particularly suits this clinical indication due to the ease of use and the ability to directly apply it to the affected area. The positive efficacious reports show effective pain relief in minutes and healing within 48 hours. The formulation has demonstrated in-vivo efficacy after two years plus in uncontrolled storage. An ongoing stability program has demonstrated excellent physical stability at room temperature and excellent chemical stability under accelerated conditions. A GLP Dermal Irritation Study in rabbits was conducted to demonstrate acceptable skin irritation for this species. Pharmacologically negligible blood levels for both of the active ingredients can be demonstrated.

Manufacturing
A proprietary manufacturing process has been developed and is both transferable and scalable.  Current batches are at the kilogram scale. The available data on the current formulation and the process is reproducible and expected to fulfill all cGMP requirements at any established third party contract manufacturer.

Clinical Exposure In Humans
Uncontrolled clinical treatment data has been documented for numerous patients with significant skin ulcers. Three anecdotal cases are summarized below which were conducted in 2004 at the  Dr. Dayan Medical Center, 39 Benjamin Motodola St., Shikun Dan, Tel-Aviv 69548

Case #1
A.A., a 67 years old Caucasian male presented to the clinic for treatment of vascular insufficiency secondary to Diabetes mellitus.  Patient complained of severe pain on ambulation, gangrenous lesions involving toes of both legs and extensive ulcerations of both calves. His past medical history was complex and included non-insulin dependent Diabetes Mellitus (NIDDM), cardiovascular atherosclerosis, renal insufficiency, obesity and hypercholesteremia. Patient was seen on numerous occasions at various clinics and hospitals and was told that due to the severity of his condition he should undergo bilateral BKA (below knee amputation).
 
Patient was started on the treatment utilizing protocol developed at our clinic, which included vasodilators, heparin, vitamins and minerals administered via IV route. The wounds of the legs were treated with specially prepared creams and external application of ozone ( O3 ). After two weeks of such therapy there was general improvement but no satisfactory healing of the wounds has been accomplished At that time it was decided to start an empirical therapy with utilization of Debride Medicated Ointment. After additional two weeks therapy there was a significant decrease in the diameter of the lesions and patient was then restarted on antibiotic creams therapy with good results. Clinical observation Utilization of Debride Medicated Ointment triggered faster closure of the superficial wounds and allowed for continuation of therapy with appropriate antibiotics.

Case #2
G.W., a 77 years old Caucasian female presented to the clinic with complains of intermittent claudications. Patient’s medical history was significant for hypertension, idiopathic vertigo and uterine cancer. Because of the presence of positive Homan’s sign bilaterally in lower extremities, patient was started on therapy involving intravenous administration of vasodilitators. On the fourth week of therapy, patient suffered accidental traumatic superficial laceration of the right foot. Debride Medicated Ointment was applied to the lesion for a period of two weeks, resulting in complete closure of the laceration. Clinical observation: Debride Medicated Ointment was effective in treatment of superficial laceration of the skin in the presence of vascular insufficiency.

Case #3
Y.K., 65 years old Caucasian male presented to the clinic for treatment of non-healing ulceration of left lower extremity. Past medical history of this patient was significant for varicose veins stripping in 1964 and again in 1989. Patient was involved in a motor vehicular accident in 1998, with resulting fractures of both ankles, fracture of the spleen, injury to the spinal column and post-traumatic pericarditis and vertigo. Following repairs of the fractures of the lower extremities, which involved installation of internal metallic hardware, patient did well until February of 2002, at which time he developed ulcerations of the medial aspect of left lower extremity. Following conventional therapy patient observed intermittent recurrence of the same lesion every 1-3 months. In the clinic the patient was started on regime consisting of intravenous administration of vasodilitators, heparin and vitamins. Treatment with antibiotic cream resulted in elimination of mild infection of the site. Afterwards treatment was continued with utilization of Debride Medicated Ointment. Complete closure of the wound was accomplished after four weeks of therapy. Clinical observation: Utilization of Debride Medicated Ointment contributed greatly to patient’s recovery and closure of the wound.
 
An ongoing compassionate clinical study is in progress in Israel at The Dr. Dayan Medical Center.

REGULATORY ISSUES
All the components of Debride WH1 are USP grade or considered GRAS. In addition, lidocaine and triamcinolone have both been approved for human use in the US and in most other countries worldwide and therefore have a significant safety and efficacy database. Furthermore, 2% lidocaine is approved as a local anesthetic under the tentative final OTC monograph for external analgesics. Registration of this product in the US will most likely require an NDA under the 505 B2 procedures. Preliminary Pre-IND discussions with the FDA have already taken place.

Intellectual Property
McCoy Enterprises LLC has applied for a formulation and use patent to protect the use of this product for the treatment of wound healing and skin ulcers. In addition, applications to PCT pact countries was submitted July 2005. At this juncture, the US patent prosecution process has progressed positively, as planned, and no untoward actions by the USPTO have occurred.

Business Opportunity
The objective of partnering will be to bring complementary strengths of organizations to ensure the best possible product development efforts, and to obtain financing to strengthen and accelerate clinical and regulatory efforts. McCoy Enterprises LLC and the partner(s) will collaborate to ensure the marketing and regulatory approval success of the product. The selection criteria for a partner would include the partner’s financial resources, past, present and future topical dermatologic and pain or complementary product portfolio, clinical/regulatory track record, marketing and sales strengths, size of the sales force and the market coverage. The preferred relationship will include a license agreement with upfront patent costs and license fees, milestone payments, royalty on net sales and a cooperation/consulting agreement with McCoy Enterprises LLC for current and future product development. In exchange, McCoy Enterprises LLC will offer exclusive market distribution and manufacturing rights for human use on a worldwide basis. McCoy Enterprises LLC is prepared to negotiate commercially reasonable terms with qualified partners. Product samples are available upon request from interested parties.

Contact Information:
  Randall E. McCoy, President
  McCoy Enterprises LLC
  10 High Court
  Little Falls, NJ  07424
 
Phone: (973) 557-8914
Fax:    (973) 200-0155
E-mail:  rmccoy18@optonline.net