Oncothyreon Inc (USA) (NASDAQ:ONTY), a clinical-stage biopharmaceutical company dedicated to the development of therapeutic products that can improve the lives and outcomes of patients with cancer, today announced dosing of the first patient in a randomized, placebo-controlled Phase 2 trial of ONT-380 in combination with Herceptin® (trastuzumab) and Xeloda® (capecitabine). ONT-380 is an oral, HER2-selective, central nervous system (CNS)-active tyrosine kinase inhibitor. The trial is enrolling heavily pretreated patients with advanced HER2-positive breast cancer with or without brain metastases.

“There is a great need for effective, well-tolerated treatments for women with progressing metastatic HER2-positive breast cancer, especially those with metastases to the brain, which develops in up to half of these patients and who are frequently excluded from clinical trials. With no approved therapy for the treatment of brain metastases, options for this patient population are currently limited,” said Erika Hamilton, M.D., director, Breast and Gynecologic Cancer Research Program, Sarah Cannon Research Institute. “This trial includes specifically designed endpoints around HER2-positive CNS disease to further explore the activity of ONT-380 in combination with Herceptin and Xeloda on brain metastases and the potential to address this unmet medical need.”

“Based on data from our Phase 1b studies, which show that the combination of ONT-380 with other active treatments was well tolerated and resulted in objective responses and prolonged, stable disease, we believe that ONT-380 has the potential to be an important new treatment for HER2-positive breast cancer patients, especially for women with brain metastases,” said Christopher S. Henney, chairman and interim CEO ofOncothyreon. “We are excited to advance the development of ONT-380 in the third-line metastatic setting with the initiation of this Phase 2 trial. Additionally, we continue to evaluate opportunities for ONT-380 and to establish the most efficient regulatory path forward.” (Original Source)

Shares of Oncothyreon closed last Friday at $1.04, up $0.01 or 0.97%. ONTY has a 1-year high of $4.69 and a 1-year low of $0.90. The stock’s 50-day moving average is $1.28 and its 200-day moving average is $2.55.

On the ratings front, Oncothyreon has been the subject of a number of recent research reports. In a report issued on January 11, Cantor Fitzgerald analyst Mara Goldstein reiterated a Hold rating on ONTY, with a price target of $3, which represents a potential upside of 188.5% from where the stock is currently trading. Separately, on December 23, Jefferies Co.’s Gena Wang initiated coverage with a Buy rating on the stock and has a price target of $4.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Gena Wang have a total average return of -16.6% and -27.8% respectively. Goldstein has a success rate of 27.9% and is ranked #3633 out of 3682 analysts, while Wang has a success rate of 15.4% and is ranked #3500.

Oncothyreon Inc is a clinical-stage biopharmaceutical company. It develops and commercialize synthetic vaccines & small molecules that treat the lives & outcomes of cancer patients.