On 5/7/09, Alexza Pharma (NASDAQ:ALXA) ($2.36) announced update on AZ-004 (Staccato loxapine) NDA timeline as the Company continues its scale-up of commercial manufacturing and quality systems processes. ALXA expects an AZ-004 NDA submission to the FDA during the first quarter of 2010 (1Q10). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder.

On 5/11/09, Acadia Pharma (NASDAQ:ACAD) ($2.01) provided the following update along with its quarterly financial results: Enrollment was completed in the Company's first pivotal Phase 3 trial of pimavanserin in patients with Parkinson's disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of 3Q09.

On 5/12/09, Celsion (NASDAQ:CLSN) ($4.47) provided an update on the status of its lead oncology compound in clinical development, ThermoDox, which is a proprietary heat-activated liposomal encapsulation of doxorubicin. ThermoDox is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient, global Phase 3 trial in patients with non-resectable primary liver cancer. Enrollment in the global Phase 3 primary liver cancer study includes 33 clinical sites activated to date with plans to increase the number of sites to 65 by the end of 2009. CLSN expects to substantially complete patient enrollment in this trial within the first quarter of 2010 (1Q10). CLSN is also conducting a pivotal Phase I/II recurrent chest wall breast cancer clinical trial for ThermoDox and is enrolling patients at four clinical sites with expected completion of patient enrollment for this study in the second quarter of 2010 (2Q10).

On 6/1/09, GenVec (NASDAQ:GNVC) ($0.72) announced that overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec's ongoing Phase 3 Pancreatic Cancer Clinical Trial with TNFerade (PACT) were presented at ASCO. The analysis concluded that TNFerade appeared to be safe and well-tolerated, indicating a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone. In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.

On 6/1/09, Antigenics (NASDAQ:AGEN) ($1.93) announced results of an interim analysis from the Company's ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010. In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma. AGEN expects a decision on its European marketing application by late 2009 and the Company has not filed for U.S. marketing approval of the drug as of yet.

On 6/10/09, Osteotech (NASDAQ:OSTE) ($4.28) announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures. DuraTech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results stemming from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.

On 6/15/09, pSivida (NASDAQ:PSDV) ($1.77) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect).