Drug Pipeline Series: Phase II, Oct 31 - Nov 6, 2006

Palatin Technologies and King Pharmaceuticals Report Results For Two Phase 2B Clinical Trials Evaluating Bremelanotide in Male Erectile Dysfunction Patients
Palatin Technologies, Inc. and King Pharmaceuticals, Inc. announced positive results from two Phase 2B trials evaluating bremelanotide for the treatment of male erectile dysfunction (ED). The two Phase 2B clinical trials were double-blind, placebo-controlled, parallel dose trials that included a one month run-in period and a three-month treatment period.

The primary efficacy endpoint for both trials was the change in the Erectile Function domain of the International Index of Erectile Function (IIEF-ED) from baseline to the end of the three-month treatment period. Study 16 was a clinical trial evaluating the safety and efficacy of bremelanotide in 726 non-diabetic patients with mild to severe ED. Study 17 similarly evaluated 294 patients with ED and diabetes mellitus. The primary objective of the studies was to characterize the efficacy and safety of bremelanotide in these two ED populations and to identify the dose(s) to use in further development. Data from these and other studies will be the basis for discussions with the U.S. Food and Drug Administration (FDA) at an end-of- Phase 2 meeting.

EntreMed Commences Phase 2 Clinical Trial With Panzem® NCD in Ovarian Cancer
EntreMed, Inc. announced commencement of a multi-center, Phase 2 clinical trial with its clinical-stage drug candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol), in patients with recurrent or resistant epithelial ovarian cancer. The study will be conducted by the Hoosier Oncology Group, headquartered in Indianapolis.

Primary objectives for this single-agent Phase 2 study will be to assess the safety, pharmacokinetics, tumor response rate, and progression-free survival (PFS) in ovarian cancer patients receiving orally-administered Panzem® NCD. Patients with recurrent or resistant epithelial ovarian cancer will be treated. EntreMed received orphan drug designation for 2ME2 from the FDA for treatment of ovarian cancer.

Hana Biosciences Initiates Phase II Trial of Talvesta (talotrexin) for Injection in Acute Lymphoblastic Leukemia
Hana Biosciences announced the initiation of a multicenter Phase II clinical trial with Talvesta™ (talotrexin) for Injection in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

The primary objective of this Phase II portion of an ongoing Phase I/II open-label study is to evaluate the complete remission rate (CR/CRp) of Talvesta in relapsed or refractory ALL patients. Secondary objectives are to evaluate the safety and tolerability of Talvesta in this setting as well as duration of complete remission and overall survival. Data from the Phase I portion of this clinical trial will be presented during the 48th Annual American Society of Hematology (ASH) Meeting in December in Orlando, Florida, on Sunday, December 10th.

Novacea Initiates Phase 1/2 Trial of AQ4N in Glioblastoma Multiforme
Novacea, Inc. announced that it has initiated a multicenter,Phase1b/2a open-label clinical trial of AQ4N (banoxantrone), in combination with radiotherapy and temozolomide, for safety, tolerability and activity in patients with newly diagnosed glioblastoma multiforme (GBM).

The trial consists of two parts. The primary objective of the first part will be to evaluate safety and tolerability of three dose levels (200 mg/m2, 450 mg/m2and 750 mg/m2). The second part will further evaluate safety and tolerability as well as efficacy and the highest safe and tolerated dose of the AQ4N treatment determined in part one. Novacea expects to enroll approximately 60 patients in the trial.

CombinatoRx Drug Candidate CRx-102 Demonstrates Positive Phase 2 Results in Rheumatoid Arthritis
CombinatoRx, Incorporated announced positive results of its randomized, blinded, placebo-controlled phase 2 clinical trial of CRx-102 in rheumatoid arthritis (RA). The trial compared CRx-102 plus a disease-modifying anti-rheumatic drug (DMARD) to placebo plus DMARD (control) in subjects with RA. In this trial, CRx-102 demonstrated statistically significant improvements on primary and secondary endpoints.

CRx-102 is an oral synergistic combination drug candidate containing the cardiovascular agent dipyridamole and an unconventionally low dose (3mg) of the steroid prednisolone. CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities without replicating its side effects.

CRx-102 was generally well tolerated and there were no serious adverse events reported for subjects treated with CRx-102. The most common adverse events observed with CRx-102 that occurred with a frequency of greater than 5% were headache, gastro-intestinal symptoms and dizziness, known side effects of dipyridamole, one of the two components of CRx-102.

Opexa Begins Dosing Patients in Phase IIb Trial of Tovaxin™ for Multiple Sclerosis
Opexa Therapeutics, Inc. announced that it has dosed the first patient in its 150-patient Phase IIb clinical trial of Tovaxin™ in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 31 trial sites in the U.S., all of which are actively recruiting patients; the first patient was treated by Dr. Suzanne Gazda, Principal Investigator at Integra Clinical Research in San Antonio, Texas.

As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.

Neurogen Announces Start of Phase II Proof-of-Concept Trial for Investigational Pain Drug
Neurogen Corporation announced that Merck & Co. Inc., through an affiliate, has begun a Phase II proof-of-concept clinical trial to study MK-2295 (NGD-8243) for the treatment of post-operative dental pain. MK-2295 is one of several drug candidates Merck is developing as part of its exclusive worldwide alliance with Neurogen to develop oral medicines targeting the VR1 receptor.

The initiation of the Phase II study triggers a $3 million milestone payment from Merck to Neurogen. Through the alliance, Neurogen and Merck have generated a broad spectrum of chemical intellectual property and several leading drug candidates, including MK-2295. The companies will select the most promising of the lead candidates for further development once proof-of-concept has been established.

The Phase II proof-of-concept trial is a randomized, double-blind, placebo controlled study, designed to determine the efficacy of MK-2295 in the treatment of post-operative dental pain. In single ascending dose Phase I trials conducted to date, MK-2295 was potent and active at the VR1 target and generally well tolerated with no serious adverse events. Multiple ascending dose studies are ongoing.

PTC Therapeutics Announces Positive Phase 2 Results For PTC124 in Cystic Fibrosis
PTC Therapeutics, Inc. announced the findings from two Phase 2 clinical trials of PTC124 in patients with cystic fibrosis (CF) due to a nonsense mutation. The results suggest that PTC124 can restore function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein in airway cells and significantly reduce blood neutrophil counts that are a hallmark of the CF disease process.
The initial data were presented at the North American Cystic Fibrosis Conference in Denver, Colorado.

PTC sponsored a multi-site, open-label, dose-ranging Phase 2 clinical trial program to determine whether PTC124 can induce production of active CFTR protein. Identical studies in the U.S. and Israel evaluated nasal transepithelial potential difference (TEPD) as a surrogate for CFTR protein production. A change in CFTR-mediated chloride transport toward normal during PTC124 treatment would suggest that PTC124 is inducing the cells to make full- length, functional CFTR protein.