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AZN's PACIFIC Proves To Have Depth, ARDX Abuzz, No Flashy Data From ALLSTAR


Today's Daily Dose brings you news about Ardelyx' phase III study results of Tenapanor in irritable bowel syndrome with constipation; Capricor's disappointing mid-stage trial data of CAP-1002; AstraZeneca's encouraging results of Imfinzi in unresectable lung cancer and Ziopharm's public offering.

Read on.

Shares of Ardelyx Inc. (ARDX) plunged more than 39% on Friday, despite reporting positive results from the first of two phase III trials evaluating Tenapanor for the treatment of patients with irritable bowel syndrome with constipation, indicating investors' skepticism.

The 12-week trial, dubbed T3MPO-1, achieved the primary endpoint of Combined Responder - i,e, a greater proportion of Tenapanor-treated patients achieved at least a 30% reduction in abdominal pain and an increase of one or more complete spontaneous bowel movements in the same week for at least 6 of the 12 weeks of treatment compared to placebo-treated patients.

The study also met seven of eight secondary endpoints.

So, what's the worry?

The most commonly reported side effect of Tenapanor is diarrhea, and in the T3MPO-1 trial, discontinuations due to diarrhea were 5.9 percent for the Tenapanor-treated patients compared to 0.6 percent for the placebo group.

Tenapanor is also being evaluated as a treatment for hyperphosphatemia in patients with end-stage renal disease. In February of this year, the Company announced successful results from its phase III hyperphosphatemia trial. But there too, the treatment discontinuation due to diarrhea for patients treated with Tenapanor was 7.8%.

On February 2, 2015, the Company had reported results from its phase IIb hyperphosphatemia trial of Tenapanor. The trial met its primary endpoint but the stock fell as much as 32% that day as the rate of diarrhea was distinctly higher than expected in Tenapanor-treated patients.

A second phase III trial of Tenapanor for the treatment of patients with IBS-C, dubbed T3MPO-2, is ongoing with data expected early in the fourth quarter of 2017.

ARDX closed Friday's trading at $7.45, down 39.18%.

Shares of AstraZeneca plc (AZN) rose more than 9% on Friday, following positive results from a phase III study of Imfinzi in patients with unresectable lung cancer.

In the phase III study, dubbed PACIFIC, Imfinzi met a primary endpoint of statistically-significant and clinically-meaningful progression-free survival in 'all-comer' patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer in a planned interim analysis.

The trial will continue to evaluate overall survival, the other primary endpoint.

Imfinzi was granted accelerated approval by the FDA on May 1, 2017 for previously treated patients with advanced bladder cancer. The drug is also being tested in the 1st-line treatment of patients with NSCLC as monotherapy and in combination with Tremelimumab.

AZN closed Friday's trading at $34.00, up 9.22%.

Shares of Capricor Therapeutics Inc. (CAPR) got hammered on Friday after a pre-specified administrative interim analysis of its ongoing phase II clinical trial of CAP-1002 in adults with cardiac dysfunction following a large heart attack found that the trial is unlikely to achieve its primary endpoint.

The trial, dubbed ALLSTAR, is a randomized, double-blind, placebo-controlled, 142-patient trial, and the interim analysis performed on the six-month follow-up data did not demonstrate evidence of scar size improvement with CAP-1002.

The Company will continue to perform analyses of the cumulative ALLSTAR data to better understand the basis for the disappointing outcome.

Last month, the Company announced positive 6-month results from its phase I/II trial of CAP-1002 for the treatment of patients with Duchenne muscular dystrophy.

The phase I/II trial of CAP-1002 is known by the name HOPE, and it is a 12-month study.

The six-month data of the study revealed that patients treated with CAP-1002 had a statistically-significant improvement compared to usual care controls in certain measures of cardiac and upper limb function.

Capricor expects to report top-line 12-month results from the HOPE-Duchenne Trial in the fourth quarter of 2017.

In order to focus its financial resources primarily on its DMD program, Capricor is planning to reduce its workforce.

CAPR closed Friday's trading at $1.16, down 61.97%.

ZIOPHARM Oncology Inc. (ZIOP) has offered to sell 9.71 million shares its common stock to the public at a price of $5.15 each.

The gross proceeds from the offering are expected to be $50 million. The offering is expected to close on May 16, 2017, subject to customary closing conditions.

The Company's lead product candidate is Ad-RTS-hIL-12, and a pivotal clinical trial of Ad-RTS-hIL-12 plus the activator ligand Veledimex in recurrent glioblastoma is planned for initiation by the end of 2017.

The Company had cash of approximately $66.4 million at March 31, 2017. ZIOPHARM anticipates that its current cash resources, after giving effect to the proceeds of the proposed offering, will be sufficient to fund its operations into the fourth quarter of 2018.

ZIOP closed Friday's trading at $7.36, up 3.37%.

by RTTNews Staff Writer

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