Drug Pipeline Series: Phase II, Nov 13 - Nov 20, 2006

CuraGen and TopoTarget Announce Initiation of NCI-sponsored Phase II Clinical Trial of PXD101 for Myelodysplastic Syndrome
CuraGen Corporation and TopoTarget A/S announced the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of Myelodysplastic Syndromes (MDS). This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101.
The primary endpoint for the study is the proportion of confirmed responses as defined by the International Working Group. Secondary endpoints include the time to progression, overall survival, duration of response, and toxicity. The pharmacodynamic activity of PXD101 will also be evaluated by the assessment of histone acetylation, gene expression profiling and DNA methylation. Patients will be enrolled at multiple sites in the United States.

Helix Biopharma Completes Phase 2 Clinical Study With Topical Interferon Alpha-2B In Patients With Low-grade Squamous Intraepithelial Lesions
Helix BioPharma Corp. announced completion of enrollment and treatment in its Phase 2 clinical study of Topical Interferon Alpha-2b in women with low-grade squamous intraepithelial lesions ("LSIL") that are positive for human papilloma virus ("HPV") infection.
The study was designed to evaluate the safety and effectiveness of Topical Interferon Alpha-2b in patients with cytologically confirmed LSIL and polymerase chain reaction ("PCR") confirmed HPV. Patients received Topical Interferon Alpha-2b therapy applied intravaginally three times a week for a period of six weeks, followed by a six week follow-up period. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the twelve week study duration.
No serious adverse drug reactions were reported in the study. The Company is completing analytical work on patient samples collected over the duration of the patient testing and will be gathering and analyzing the final data. The Company expects to complete all data analyses and report the final integrated study findings during the first quarter of calendar 2007.

Human Genome Sciences Announces Positive 76-Week Results of Phase 2 Clinical Trial of LymphoStat-B™ in Systemic Lupus Erythematosus
Human Genome Sciences, Inc. announced that the 76-week results of a Phase 2 clinical trial demonstrated that LymphoStat-B™ (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE), exhibited durable biological activity, and appeared safe and well tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase 3 trials of LymphoStat- B™ increased from 46% at Week 52 to 56% at Week 76, with no increase in infections or infectious events observed over time.
The results were presented in two oral presentations in Washington, DC at the 70th Annual Meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals (ACR/ARHP). Additional LymphoStat-B results were reported in poster presentations throughout the meeting.

Quigley Pharma's QR-333 Phase IIb Clinical Study Has Commenced; Drug Product and Clinical Trial Sites Prepared for Phase IIb Study of Lead Drug Candidate
Quigley Pharma Inc. announced that patient enrollment in a phase IIb multi center clinical study of QR-333 for the treatment of symptomatic Diabetic Peripheral Neuropathy (DPN) has commenced. The Phase IIb double blind multi-center study will evaluate the safety and efficacy of QR-333, as compared to placebo-treated patients. The active QR-333 Investigational New Drug and placebo have been prepared for shipment and will be available to clinical investigators to begin treatment starting in December.
The Phase IIb trial will evaluate the safety and efficacy of QR-333 applied three times daily compared to placebo-treated patients over 12 weeks. Efficacy will be determined by Symptom Assessment Scores, a Visual Analogy Scale (VAS), Quality of Life and Sleep Questionnaires. Safety will be determined by medical history, physical examination, vital signs, 12-lead ECG, laboratory tests and nerve conduction studies. The study will involve 150-200 randomized male and female patients with Type 1 & 2 diabetes, as defined by the ADA (American Diabetes Association) and distal symmetric diabetic polyneuropathy.

EVOTEC BEGINS TRIAL OF INSOMNIA DRUG IN ELDERLY PATIENTS
Evotec has announced the initiation of a second Phase II study with EVT 201 under an investigational new drug application. This randomized, multicenter, double-blind study is a parallel design study with two doses of EVT 201 and placebo in 135 elderly patients with chronic primary insomnia and daytime sleepiness. It is designed to assess the hypnotic efficacy of EVT 201 during seven nights of treatment and also to determine the effect of improved sleep quality on daytime performance.
According to the company, the elderly are a significant portion of the insomnia patient population.
The primary endpoint of this trial is to assess total sleep time determined by polysomnography. The secondary endpoints include a variety of tests of daytime sleepiness and functional performance as well as additional sleep efficacy measures such as latency to persistent sleep, wake after sleep onset and number of awakenings, determined by polysomnography. In addition, effects on sleep architecture will be examined and patients will evaluate sleep quality and quantity subjectively.
In September Evotec initiated its first Phase II clinical trial with EVT 201, which is ongoing. Prior to this, in two Phase I/II studies using the traffic noise model of insomnia in healthy male volunteers, EVT 201 significantly reduced wake after sleep onset while significantly increasing total sleep time and quality of sleep with no subjective residual effects. The compound was well-tolerated without significant adverse events.