Topsalysin successfully ablated tumor cells in patients with clinically significant localized disease

 

SAN DIEGO and VANCOUVER, British Columbia, June 9, 2016 - Sophiris Bio Inc. (SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced the biopsy results from all 18 patients enrolled in the Phase 2a proof of concept study of topsalysin in localized prostate cancer. The one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported. Topsalysin demonstrated an ability to ablate tumor cells in 50 percent of patients (9/18 patients) six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The results support advancing topsalysin into a Phase 2 study to confirm dose and optimize delivery.

SAN FRANCISCO--- Jaguar Animal Health, Inc. (JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced today that it has entered into a $15 million common stock purchase agreement (the “Agreement”) and a registration rights agreement with Aspire Capital Fund, LLC ("Aspire"), a Chicago-based institutional investor. Immediately upon the execution of the Agreement, Aspire purchased 222,222 shares of Jaguar common stock for $500,000.

 

After a registration statement related to the transaction has been filed and declared effective by the U.S. Securities and Exchange Commission, Jaguar will have the right to sell up to the remaining $14.5 million of its common stock to Aspire under the Agreement over a 30-month period, at prices based on prevailing market prices at the time of each sale, and Aspire has the obligation to purchase common stock from Jaguar in amounts and timing determined by Jaguar in its sole discretion. The Agreement does not contain any financial covenants, restrictions on future financings, rights of first refusal, limits to the use of any of the proceeds, participation rights or penalties. Jaguar can terminate the Agreement at any time without any penalty.

CAMBRIDGE, Mass.-- Sarepta Therapeutics, Inc. (SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has requested that Sarepta provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (PROMOVI), as part of its ongoing evaluation of the eteplirsen New Drug Application (NDA). The Company plans to submit data from thirteen patient biopsy samples, at baseline and Week 48, to the FDA over the coming weeks to facilitate a prompt decision on the NDA by the Agency.

Encouraging results in ONT-380 combination therapy in patients with and without brain metastases

 

CHICAGO, June 05, 2016 - Oncothyreon Inc. (ONTY), a clinical-stage biopharmaceutical company, today announced the presentation of clinical data on its lead product candidate, ONT-380, at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO). ONT-380 is a highly selective small molecule HER2 inhibitor being developed in combination to treat HER2+ advanced or metastatic breast cancer.

 

Data from a poster presentation (#513 “Efficacy Results of a Phase 1b Study of ONT-380, a CNS-Penetrant TKI, in Combination with T-DM1 in HER2+ Metastatic Breast Cancer (MBC), Including Patients with Brain Metastases”) showed promising safety and efficacy results in a Phase 1b study as treatment in patients with progressive disease who were previously treated with trastuzumab and a taxane.