A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Inclusion Criteria:

- Provide informed consent

- Age ≥ 18 years and of either sex

- Willing to comply with protocol instructions, including allowing all study
assessments

- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus),
with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm

- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular
or venous incompetence

- Arterial supply adequacy confirmed

- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon,
muscle, or bone

- Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months).

- Acceptable state of health and nutrition

Exclusion Criteria:

- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin,
bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin
B or any other component of HP802-247,or known sensitivity to Iodine

- Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody
titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of
vasculitis, or current diagnosis of claudication

- Therapy with another investigational agent within thirty (30) days of Screening, or
during the study, or any participation in a previous HP802-247 trial

- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis
lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic)

- Documented history of osteomyelitis at the target wound location within 6 months
preceding the Screening Visit

- Refusal of or inability to tolerate compression therapy

- Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft,
biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™)
within 30 days preceding the Screening Visit

- Therapy of the target ulcer with topical growth factors within 1 week preceding the
Screening Visit

- Current therapy with systemic antibiotics

- Current systemic therapy with cytotoxic drugs

- Current therapy with chronic (> 10 days) oral corticosteroids

- Current therapy with TNFα inhibitors

- History of cancer in the preceding 5 years (other than carcinoma in situ of the
cervix or adequately treated non-melanoma skin cancers)