FDA Nod For SGEN's Adcetris, Antibe Soars On GI Data, CHMA Empowered

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Today's Daily Dose brings you news about Antibe's safety study results of ATB-346; Immunovaccine's upcoming clinical trial catalysts; Chiasma's progress in the development of octreotide capsules in the treatment of acromegaly; KemPharm's pharmacokinetic study with a KP415/d-methylphenidate in ADHD; NovaBay's strong financial performance and FDA approval of Seattle Genetics' ADCETRIS for the fifth indication.

Read on…

Shares of Antibe Therapeutics Inc. (ATE.V) (ATBPF.OB) soared more than 70% on Tuesday, following positive results from its phase 2B gastrointestinal safety study of ATB-346.

The double-blind study was conducted in 244 healthy volunteers and was designed to demonstrate the superiority of ATB-346 in GI safety compared to naproxen, the most prescribed nonsteroidal anti-inflammatory drug in the U.S.

According to the trial results, subjects on ATB-346 exhibited an ulceration rate of 2.5% versus an ulceration rate of 42.1% for subjects on naproxen at the end of the 2-week treatment period, with a very high degree of statistical significance. ATB-346 was also safe and well tolerated.

ATBPF.OB closed Tuesday's trading at $0.48, up 74.9%.

Chiasma Inc. (CHMA) is making progress in its mission of advancing octreotide capsules, conditionally trade-named MYCAPSSA, as a maintenance treatment for adult patients with acromegaly.

A phase III trial of octreotide capsules in 50 adult acromegaly patients (at least 20% of whom must be recruited from the United States) whose disease is biochemically controlled, dubbed CHIASMA OPTIMAL, is ongoing. Top-line data from this trial are expected by the end of 2019.

Another trial known as MPOWERED, which is an international phase III clinical trial under a protocol accepted by the European Medicines Agency evaluating octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly, is also ongoing.

The Company previously estimated that up to 150 patients would be required for the MPOWERED trial. But now, it is estimated that only 130 patients will be required to enter the 6-month run-in phase of MPOWERED trial. Top-line data from the MPOWERED trial is anticipated in 2020.

CHMA closed Tuesday's trading at $1.55, up 3.33%.

Immunovaccine Inc. (IMV.TO) (IMMVF.OB) has a couple of catalysts to watch out for in the coming months.

The Company's lead investigational drug is DPX-Survivac.

A phase Ib trial evaluating the safety and efficacy of DPX-Survivac, in combination with Incyte Corp.'s (INCY) IDO1 enzyme inhibitor epacadostat, and low-dose cyclophosphamide, in patients with advanced ovarian cancer is underway. Initial results from 10 evaluable patients treated with DPX-Survivac plus-100 milligrams epacadostat dosing, reported last December, were promising.

Top line clinical results with the 300mg dose are expected around mid-year, and an update on the 300mg dose clinical results is anticipated in Q-3 2018.

A phase II clinical trial evaluating DPX-Survivac in combination with Merck's (MRK) Keytruda in patients with recurrent, platinum-resistant ovarian cancer is ongoing. Preliminary clinical results from this trial are anticipated around mid-year, with top line clinical results to be reported around the end of the year or beginning of 2019.

A phase II clinical study evaluating DPX-Survivac in combination with Merck's Keytruda in patients with diffuse large B-cell lymphoma is also ongoing, with preliminary clinical results expected around mid-year, and topline clinical results expected around the end of the year or beginning of 2019.

IMMVF.OB closed Tuesday's trading at $1.49, up 0.47%.

KemPharm Inc.'s (KMPH) pharmacokinetic study with a KP415/d-methylphenidate (d-MPH) capsule in children 6-12 years and adolescents 13-17 years old with ADHD has yielded positive results.

The results suggest that following oral administration of KP415 product candidate, exposure to d-methylphenidate is predictable in patients with attention-deficit/hyperactivity disorder (ADHD) between the ages of 6 and 17 years.

"Two of the benefits of d-methylphenidate (d-MPH) are, according to published literature, drug exposure from a specific product is comparable between age groups after adjusting for dose and body weight, and there is a direct correlation between that exposure and the clinical response," added Travis Mickle, CEO of the Company.
Top line results from an on-going pivotal efficacy laboratory classroom study with KP415 in children with Attention-Deficit/Hyperactivity Disorder are expected by mid-year.

KMPH closed Tuesday's trading at $7.00, up 6.06%.

NovaBay Pharmaceuticals Inc. (NBY) has reported strong financial performance in its fourth quarter and full year.

Net income for the fourth quarter of 2017 was $0.8 million, or $0.02 per share compared to a net loss of 2016 of $1.6 million or $0.13 per share in the year-ago quarter.

Net sales for the fourth quarter of 2017 were $6.3 million, an increase of 55% from $4.1 million for the fourth quarter of 2016.

NBY closed Tuesday's trading at $3.63, up 2.85%.

The FDA has approved Seattle Genetics Inc.'s (SGEN) ADCETRIS for yet another indication - this time, in combination with chemotherapy in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma. The FDA decision has come nearly 1.5 months ahead of the scheduled Prescription Drug User Fee Act goal date of May 1, 2018.

This is the fifth FDA-approved indication for ADCETRIS.

The drug is also approved for adult patients with: (1) classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (2) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (4) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, according to the Company.

ADCETRIS raked in annual sales of $307.6 million in 2017 compared to $265.8 million in 2016.

SGEN closed Tuesday's trading at $54.86, down 1.56%.

Therapix Biosciences Ltd. (TRPX) is all set to initiate a phase IIa clinical trial THX-110 in the treatment of Chronic Low Back Pain in the second quarter of 2018. About 20 subjects are expected to participate in this trial.

THX-110 is also being explored in the treatment of Tourette syndrome (TS) and Obstructive Sleep Apnea (OSA).

TRPX closed Tuesday's trading at $5.64, down 2.76%.

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