On Wednesday, Shares of Sophiris Bio Inc (NASDAQ:SPHS), gained 22.28% to $2.25.
Sophiris Bio Inc., declared financial results for the three and nine months ended September 30, 2015.
Business Highlights:
On November 10, 2015, the Company declared final positive results from its Phase 3 “PLUS-1” study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). PRX302 demonstrated a statistically noteworthyimprovement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months contrast to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. The clinical relevance of the overall improvement in IPSS was assessed by an additional efficacy endpoint, the patient self-assessment of the impact of treatment on their quality of life, which was assessed using the 0 – 6 point Quality of Life from the IPSS questionnaire. The PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to patients treated with vehicle for every post-baseline visit startning at week 18 (reaching p = 0.004). PRX302 treatment was generally well tolerated in the study and continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.
A total of 17 patients with clinically significant, localized low to intermediate risk prostate cancer have been enrolled in the ongoing Phase 2a proof of concept study. The study utilizes formerly obtained MRI images mapped to real time 3D ultrasound to target the delivery of PRX302 directly into and around a pre-identified clinically noteworthytumor. The study is being conducted at a single center well known for the focal treatment of prostate cancer in the UK. Although the primary objective of the study is to assess safety and tolerability, potential efficacy will be assessed by biopsy after six months. The Company anticipates to have initial data on histological and MRI changes after six months for about half the patients in early 2016 and final data on all patients in the second quarter of 2016.
“We have remained focused and diligent at Sophiris as we approach key data milestones, and that steadfast commitment and belief in our topsalysin programs is paying off,” stated Randall Woods, president and CEO of Sophiris Bio. “The successful outcome of the Phase 3 PLUS-1 study indicates that patients treated with topsalysin practiced a noteworthy improvement in their BPH symptoms and their quality of life. These data improvement our confidence in the targeted mechanism by which topsalysin ablates prostate tissue, thus supporting our rationale for advancing the development of topsalysin as a treatment for localized prostate cancer. We are fast approaching another key data milestone in early 2016, in which we anticipate initial data from a Phase 2a proof of concept trial of topsalysin in patients with localized low to intermediate risk prostate cancer.”
Sophiris Bio, Inc., a clinical-stage biopharmaceutical company, focuses on the development of products for the treatment of urological diseases. The company’s primary product candidate is PRX302, which is in Phase III clinical trial for treatment for the symptoms of benign prostatic hyperplasia (BPH), in addition to for the treatment of localized low to intermediate risk prostate cancer.
Shares of Retail Me Not Inc (NASDAQ:SALE), inclined 2.55% to $9.24, during its last trading session.
Retail Me Not, declare the launch of the company’s year-long “Save It Forward” campaign designed to promote goodwill and benefit charitable causes this holiday season. Retail Me Not users report an average savings of $20 per transaction when shopping, so the company wants to encourage people to use the money saved to give back and assist others. To amplify the cause, Retail Me Not will make a donation to the Boys & Girls Clubs of America for every act of kindness posted to social media using #Save It Forward and tagging @Retail Me Not.
Retail Me Not, Inc. operates a digital coupon marketplace. Its marketplace connects consumers with retailers and brands. The company owns and operates digital coupon Websites, counting RetailMeNot.com in the United States; VoucherCodes.co.uk in the United Kingdom; and Bons-de-Reduction.com, Poulpeo.com, and Ma-Reduc.com in France.
Finally, Shares of Dollar Tree, Inc. (NASDAQ:DLTR), ended its last trade with 3.74% gain, and closed at $66.63.
Dollar Tree, will host its conference call on Tuesday, November 24, 2015 at 9:00 a.m. Eastern Time,for investors and analysts to discuss financial results for the third quarter ended October 31, 2015.
Dollar Tree, Inc. operates discount variety stores in the United States and Canada. Its stores offer merchandise at the fixed price of $1.00. The company’s stores provide consumable merchandise, which comprises candy and food, and health and beauty care products; and everyday consumables, such as paper and chemicals, and frozen and refrigerated food.