Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 9 December 1996.
METHODS: Dr. Breneman reported interim data on 30 CTCL patients with histologically confirmed, stage I/IIA mycosis fungoides. Patients initially applied Targretin Topical Gel once or twice a day using gradually escalating drug concentrations (0.1% gel QD and then escalated every two weeks as tolerated to 0.1% BID, 0.5% QD, 0.5% BID, 1.0% QD, and 1.0% BID.)
RESULTS: According to Dr. Breneman, Targretin Topical Gel treatment was accompanied by some retinoid erythema and irritation but was generally well- tolerated. Dermatologic effects related to treatment were not unusual for a topical retinoid. A response to treatment of at least 4 weeks duration was achieved in 11 out of 27 evaluable patients (41%) at the time of this assessment. One patient had complete clearing and 10 patients had partial response (greater than or equal to 50% clearing); four of the responders cleared by greater than or equal to 90%. In this assessment of ongoing study, 18 patients (67%) had at least mild improvement (greater than or equal to 25% clearing). Clinical signs and symptoms of CTCL index lesions scored at baseline improved during treatment for erythema, plaque elevation, scaling and puritus. The median duration of therapy was 22+ weeks with the longest duration being 51 weeks. The median time to initial response (greater than or equal to a 50% clearing) was 12 weeks and the median time to best response was 16 weeks. Responses were durable with 11 of 11 patients maintaining response at a median duration of 8+ weeks at assessment.
CONCLUSIONS: Dr. Breneman concluded that Targretin (LGD1069) Topical Gel may provide CTCL patients a therapeutic alternative to the current treatment options. It appears to be well-tolerated even with long-term application and the drug merits evaluation in additional patients in both oral and topical forms.
Results of Phase I/II studies reported earlier this year indicated that both oral and topical formulations of Targretin (LGD1069) have activity in the treatment of CTCL. Based on the activity observed with oral and topical Targretin in CTCL, systemic therapy with Targretin Oral capsules in CTCL is being assessed. Two Phase II/III studies of Targretin Oral capsules in CTCL are now open to enrollment. Topical Targretin is in Phase III registration trials for CTCL. In addition to the pivotal CTCL Phase III trials of Oral and Topical Targretin, Oral Targretin (LGD1069) is in Phase II/III trials in patients with advanced lung cancer, and in Phase IIb trials in patients with head and neck cancer, Kaposi's sarcoma (KS), and kidney cancer. Earlier this year investigators at Memorial Sloan-Kettering Cancer Center and Georgetown University Medical Center reported stabilization of disease in some lung cancer patients treated with Targretin Oral capsules.
Targretin (LGD1069) is a compound discovered by Ligand scientists which selectively activates a subclass of retinoid receptors called RXRs which play an important role in several cellular activities. One of the potentially most important of these activities is called programmed cell death, or "apoptosis," a natural process by which the body rids itself of unwanted cells.
Ligand Pharmaceuticals Incorporated, founded in 1987, is a leader in gene transcription technology, particularly intracellular receptor (IR) technology and Signal Transducers and Activators of Transcription (STATs). Ligand has applied IR and STATs technology to the discovery and development of small molecule drugs to enhance therapeutic and safety profiles and to address major unmet patient needs in cancer, women's health, skin and metabolic diseases, osteoporosis, cardiovascular and inflammatory disease.
This press release contains certain forward looking statements by Ligand and actual results could differ materially from those described as a result of factors including, but not limited to, the following: There can be no assurance (a) that interim results will be predictive of any final results; (b) that these or any new products under development by Ligand or any of its partners will receive approval from the U.S. Food and Drug Administration or other authorities to market any of these products; (c) that, if approved, there will be a market for the drugs.
NOTE: If you would prefer to receive Ligand's press releases via e-mail, please inform us at investors@ligand.com and request to be placed on our priority e-mail list.
CONTACT: Susan E. Atkins, Vice President of Corporate Communications and Investor Relations for Ligand Pharmaceuticals, 619-550-7687/ 16:00 EST
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