LXRX Brings Sweet Tidings, PFE's PROSPER Ahead Of Schedule, XBIT Fails To Excite

(RTTNews) - Today's Daily Dose brings you news about Lexicon Pharma's inTandem3 results; EyeGate's public offering; Pfizer's progress, Cellect's exit from Israeli Exchange and XBiotech's not so exciting XCITE results.

Read on...

Astellas Pharma Inc. and Pfizer Inc. (PFE) on Friday announced that they have amended the protocol for the phase III trial of XTANDI in patients with non-metastatic Castration-Resistant Prostate Cancer.

The amended protocol allows for a reduction in the target sample size in the phase III study to approximately 1,440, from 1,560 patients. The primary endpoint of the trial, dubbed PROSPER, remains the same - metastasis-free survival.

The companies now anticipate PROSPER top-line results to be disclosed later this year, nearly 2 years ahead of schedule.

XTANDI is approved by the FDA for the treatment of patients with metastatic CRPC, based on clinical studies showing statistically significant overall survival benefit versus placebo. XTANDI, which generates over $2 billion in annual sales, came under Pfizer's fold, when it acquired Medivation for $14 billion last August.

PFE closed Friday's trading at $32.77, up 3.21%.

Cellect Biotechnology Ltd. (APOP) has decided to voluntarily delist its shares from trading on the Tel Aviv stock exchange, and the last trading day on that exchange will be September 3, 2017.

The Company will trade its American Depositary Shares, each of which represents 20 ordinary shares, exclusively on the NASDAQ.

The decision to delist from the Tel Aviv exchange was taken as the Company's board of directors and management believe it will maximize shareholders' value in the medium and long term.

Commenting on the development, Cellect Chairman, Nuriel Chirich Kasbian said, "Our shareholders will be able to convert their ordinary shares to NASDAQ American Depositary Shares through their bank or broker. The Company will bear the bank or broker's conversion fees for all shareholders who convert their ordinary shares until July 31st, 2017."

APOP closed Friday's trading at $7.60, down 1.81%.

Shares of EyeGate Pharmaceuticals Inc. (EYEG) plunged over 17% on Friday after the Company priced its offering of 6.66 million shares at $1.50 per share of common stock, with each share of common stock sold with one five-year warrant to purchase one share of common stock, at an exercise price of $1.50 per share.

The gross proceeds from the offering are expected to be $10.0 million. The offering is expected to close on or about June 14, 2017.

The Company had cash of $5.4 million at March 31, 2017.

EYEG closed Friday's trading at $1.39, down 17.26%.

Lexicon Pharmaceuticals Inc.'s (LXRX) phase III study of Sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy has met the primary endpoint.

In the study, dubbed inTandem3, Sotagliflozin 400 mg has demonstrated superiority over placebo in the proportion of patients with A1C of less than 7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis after randomization.

If approved, Sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type 1 diabetes, noted the Company.

LXRX closed Friday's trading at $16.40, up 6.77%.

Sanofi (SNY) and Regeneron (REGN), on Sunday, announced positive results from two phase 3b/4 studies evaluating Praluent in individuals with diabetes and hypercholesterolemia.

In the first study, dubbed ODYSSEY DM-INSULIN, Praluent, when administered on top of maximally tolerated doses (MTD) of statins, significantly reduced low-density lipoprotein cholesterol. In the second study, named ODYSSEY DM-DYSLIPIDEMIA, Praluent, when administered on top of maximally tolerated doses of statins, was superior to usual care in reducing non-high-density lipoprotein cholesterol.

In the ODYSSEY DM-INSULIN trial, Praluent in combination with MTD statins reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. In the ODYSSEY DM-DYSLIPIDEMIA trial, Praluent in combination with MTD reduced measured LDL-C by 43.3 percent from baseline compared to a 0.3 percent increase for usual care.

Praluent, developed by Sanofi and Regeneron, was approved by the FDA on July 24, 2015 for adults with primary hypercholesterolaemia or mixed dyslipidaemia to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins.

Both studies also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the Phase 3 program, known as ODYSSEY.

The global net sales of Praluent were $116 million in 2016 compared to $11 million for the full year 2015.

REGN closed Friday's trading at $475.79, down 2.08%.

Shares of XBiotech Inc. (XBIT) plunged 66% on Friday, following an Independent Data Monitoring Committee's recommendation to terminate the Company's phase III study of Xilonix for the treatment of colorectal cancer.

In the phase III study, dubbed XCITE, colorectal cancer patient were randomized 2:1 to receive Xilonix or placebo plus, in each case best supportive care. The primary endpoint of this study was overall survival, with secondary endpoints including objective response rate, progression free survival, change in lean body mass and patient reported quality of life measures.

The Independent Data Monitoring Committee, which performed its second prospectively planned, unblinded analysis of the XCITE study, found that the findings were not sufficient to meet efficacy or the threshold for continuation of the study.

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended against approving Xilonix in Europe.

XBIT closed Friday's trading at $3.20, down 66.03%.