These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.
On 6/15/09, Transdel Pharma (OTC:TDLP) ($1.40) announced that the Company anticipates reporting top-line results from their current Phase 3 study of Ketotransdel during 3Q09. The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug (NSAID), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the U.S. and will enroll about 350 patients. TDLP plans to initially seek FDA approval of Ketotransdel for the treatment of acute pain and then expand the label to include additional indications such as osteoarthritis.
On 6/16/09, ARYx Therapeutics (NASDAQ:ARYX) ($4.52) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. Based upon recent interactions with the FDA, ARYX believes this trial could be positioned as one of the required registration studies for tecarfarin.
Tecarfarin is modeled on the drug warfarin as an oral blood thinner, which works in the same way (as a selective inhibitor of VKOR or the vitamin K epoxide reductase enzyme). Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYX believes this alternate metabolic pathway for tecarfarin may result in more predictable dosing and anti-coagulant response compared to warfarin.
On 6/30/09, Chelsea Therapeutics (NASDAQ:CHTP) ($4.24) reached its target enrollment of 82 patients for Study 302, the first of two pivotal Phase 3 clinical trials in the Company's registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). CHTP expects to report the top-line results from this trial and complete enrollment in a second ongoing Phase 3 trial during 3Q09. The Company also plans to submit a U.S. marketing application to the FDA during 4Q09.
On 6/30/09, CytRx Corp. (NASDAQ:CYTR) ($1.19) announced that it filed a report (including results from an animal toxicology study) with the FDA in response to the Agency's partial clinical hold on the Company's Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). CYTR expects that the FDA will review the report during 3Q09 and stated that the Agency's partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events.
On 6/11/09, Human Genome Sciences (NASDAQ:HGSI) ($2.88) announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.
HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. On 7/1/09, HGSI announced that it expects to have top-line results available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 a.m. ET.
