$RXII $ECYT $VICL Phase 2 News

WORCESTER, Mass.–(BUSINESS WIRE)–RXi Pharmaceuticals Corporation (NASDAQ: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting. RXi is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer.

The NeuVax Phase 2 trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS), the same endpoint in the FDA approved SPA (Special Protocol Assessment) for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study.

… Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study expected to initiate in 1H 2012 under FDA approved Special Protocol Assessment (SPA)

http://tinyurl.com/3mpymt8

 

WEST LAFAYETTE, Ind., June 5, 2011 (GLOBE NEWSWIRE) – Endocyte, Inc., (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced that the Phase 2 PRECEDENT trial, investigating the company’s lead drug candidate, EC145, in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, met its primary endpoint by showing an 85 percent, 2.3 month, improvement in median progression-free survival (PFS) in the intent-to-treat population and a 260 percent, 4.0 month, improvement in a subset of folate receptor positive patients. EC145 in combination with PLD showed limited additional toxicity compared to standard therapy with PLD alone. The most commonly occurring adverse events were neutropenia, small intestine obstruction, and palmar-plantar erythrodysesthesia. EC145 is a therapeutic that targets the folate receptor and EC20 is a companion imaging diagnostic used to assess folate receptor presence.  

http://tinyurl.com/3l97vu9

CHICAGO, June 6, 2011 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today announced results from new statistical analyses of data from three previously completed clinical trials of the company’s Allovectin^® immunotherapy in patients with metastatic melanoma, showing with strong positive correlation that responders lived significantly longer than nonresponders. In a Phase 2 study of high-dose (2 mg) Allovectin^® in 127 chemo-refractory or chemo-intolerant patients with metastatic melanoma, the overall survival was 65% at one year, 43% at two years, and 32% at three years. The median overall survival was 18.8 months (95% CI: 14.8 – 26.2 months). Survival among the 15 clinical responders ranged from 18 months to more than seven years (median survival not reached; 95% CI: 35.5 months – not reached). The median overall survival for nonresponders in the Phase 2 study was 16.2 months (95% CI: 13.3 – 21.2 months), which is notably longer than historical survival for other metastatic melanoma treatments, suggesting that these patients also may have derived clinical benefit from Allovectin^®.

http://tinyurl.com/3lxzllq