Drug Pipeline Series: Phase II, Nov 6 - Nov 13, 2006

Callisto Pharmaceuticals Initiates Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer
Callisto Pharmaceuticals, Inc. announced the first dosing of patients in a multi-center, open-label Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinomas including advanced carcinoid cancers. The first study site to enter this trial is the Hematology Oncology Services of Arkansas in Little Rock, Arkansas, under the direction of Brad Baltz, M.D., the principal investigator. Several major cancer centers are currently reviewing the trial protocol and the Company anticipates that these sites will open in the near future.

The primary objective of the Phase II clinical trial is to evaluate efficacy of Atiprimod in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable cancer and who have either symptoms, despite standard therapy (octreotide), or progression of neuroendocrine tumors. Patients, after signing an informed consent, are required to complete two weeks of a symptoms diary to establish their symptoms baseline before commencing Atiprimod dosing. A maximum of 40 evaluable patients will be enrolled in this trial.


Osiris Therapeutics Reports Positive Phase II Results Using PROCHYMAL™ for the Treatment of Acute Graft vs. Host Disease
Osiris Therapeutics, Inc. announced positive results from a 32 patient Phase II study using PROCHYMAL for the treatment of acute Graft vs. Host Disease or GVHD. In the study, 29 of 31, or 94% of evaluable patients responded after receiving two infusions of PROCHYMAL. More significantly, 23 patients, or 74% achieved a complete response, meaning the patients had experienced total clinical resolution of the disease. Currently, PROCHYMAL is being evaluated in a Phase III trial for the treatment of steroid refractory GVHD.

The trial was a randomized, prospective, open label trial, conducted at 16 leading cancer centers within the US. In addition to standard care including steroids, patients were given two infusions of PROCHYMAL three days apart at the onset of moderate to severe (grades II-IV) GVHD. Patients were divided into two groups and received either low dose (2 million cells per kilogram) or high dose (8 million cells per kilogram) of PROCHYMAL. Endpoints of the study included response of GVHD to treatment with PROCHYMAL and the safety and tolerability of the drug at the two different dose levels.


Targacept Announces Positive Results of Phase II Clinical Trial in Major Depression
Targacept, Inc. reported positive results from a double blind, placebo controlled Phase II clinical trial of mecamylamine hydrochloride as an augmentation treatment for major depression. The trial (n=184) evaluated the effects of mecamylamine taken with citalopram hydrobromide, a treatment combination known as TRIDMAC, in patients who did not respond adequately to citalopram alone. Citalopram hydrobromide is a commonly prescribed treatment for depression marketed as Celexa® in the United States.

On one of two primary endpoints in the trial, patients receiving TRIDMAC showed greater improvement on symptoms of depression, as measured by group mean change from baseline on the Hamilton Depression Rating Scale (HAM-D), than patients receiving placebo with continued citalopram therapy. This result was statistically significant on an intent to treat basis (p=0.041) and showed a strong trend on a per protocol basis (p=0.059). HAM-D is a commonly used 17-item scale that evaluates depressed mood and other symptoms of depression and anxiety. The result on the trial's other primary endpoint, achievement of remission, favored the TRIDMAC group over the placebo group, although this result did not reach statistical significance. In addition, the trial included five other rating scales as secondary measures. The results on all five rating scales favored the TRIDMAC group over the placebo group with statistical significance (p<0.05) on a per protocol basis. On an intent to treat basis, the results on three of the five rating scales were statistically significant.