Moleculin Biotech, Inc. is a pre-clinical and clinical-stage pharmaceutical company focused on the development of game-changing anti-cancer drug candidates, many of which are based on discoveries made at M.D. Anderson Cancer Center. Each of our projects represents a breakthrough discovery and a highly disruptive technology.

About CTCL

ctclCutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin’s lymphoma, is a rare cancer that occurs when T-cells in the skin grow uncontrollably. It is estimated that about 16,000 to 20,000 people in the U.S. have CTCL with a higher incidence in men between the ages of 50 and 60 years old.

CTCL is often mistaken for eczema, psoriasis or contact dermatitis, since it initially presents as patches or plaques. Over time, the patient may develop tumors or generalized erythroderma (abnormal redness of the skin over widespread areas of the body).

The disease is categorized as Stages I-IV, each of which represents an increased risk for metastasis, or the spread of cancer to distant parts of the body. About three-quarters of the patient population fall into Stages IA, IB and IIA, the lower risk group. Once the disease becomes systemic, however, the prognosis—or outlook—is significantly worse. Beginning with Stage IIB, CTCL is considered progressive (or advanced) and median survival drops to 4 years.

Treatment options vary based on the subtype of CTCL, as well as the current stage of the cancer. The first-line therapy for Stage IA and IB is generally topical steroids and retinoids, however response rate is low and recurrence is common. Topical nitrogen mustard preparations are sometimes prescribed off-label with response rates of 30% to 50%, but the response is typically brief in duration.

As a second-line therapy, Targretin—a retinoid treatment— has shown minimal effectiveness, with response rates below 30% for Stage IA and IB patients and no response for those in Stage IIA. In addition, there is a relatively high incidence of drug reaction (dermatitis and hyperpigmentation) limiting the duration of treatment (Eisai Inc. 2012).

For later stage CTCL, potentially toxic treatments like electron beam radiation and chemotherapy may be the patient’s only option in attempting to slow the growth of cancer.

MOL4249: Potential for fighting cutaneous T-cell lymphoma

Preliminary in vitro and in vivo research has demonstrated the potential for our drug candidate MOL4249 to be effective in this rare cancer. Specifically, we envision MOL4249 in topical ointment or gel formulation for the treatment of early stage, non-metastatic (Stage IA through IIA) CTCL.

The Company expects to file an Investigational New Drug (IND) application with the FDA for the treatment of CTCL in the coming year, with the possibility of achieving orphan drug status and accelerated review.

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