OTIC Data No Music To Ears, KMPH's Filing On Track, BIOD For The Long Haul

(RTTNews) - Biodel Inc. (BIOD) has initiated a phase 2b clinical trial of BIOD-531 in patients with insulin-treated type 2 diabetes.

The study is designed to enroll about 130 patients at 25 U.S. investigative centers, and top line results are expected in mid-2016.

BIOD closed Thursday's trading at $1.14, up 1.79%.

CytRx Corp.'s (CYTR) updated results from its ongoing phase II clinical trial with Aldoxorubicin for the treatment of unresectable glioblastoma multiforme has now shown two complete responses, in addition to tumor shrinkage, prolonged stable disease, and favorable tolerability in patients.

The results suggest the possibility that the administration of Avastin after treatment with Aldoxorubicin could prolong survival in patients with relapsed glioblastoma multiforme, noted the company.

The company looks forward to submitting the results from the ongoing phase II clinical trial for presentation at a neuro-oncology-focused medical meeting in 2015.

CYTR closed Thursday's trading 3.23% higher at $4.15.

Intellipharmaceutics International Inc. (IPCI) (I.TO) may be able to accelerate the development and commercialization of its abuse deterrent Rexista Oxycodone XR product candidate as it has been notified by the FDA that phase III studies are not required to be conducted if bioequivalence to Oxycontin is demonstrated.

Accordingly, the company intends to file a New Drug Application for Rexista Oxycodone XR with the FDA within the next 6 to 12 months.

IPCI closed Thursday's trading 8.49% higher at $2.94.

KemPharm Inc. (KMPH), which concluded a pre-New Drug Application meeting with the FDA for its lead pain candidate, KP201/APAP, anticipates filing under the 505(b)(2) pathway in the second half of 2015, as previously planned.

In the near term, the company looks forward to completing the oral and intranasal human abuse liability clinical trials comparing KP201/APAP to Norco, and analyzing the data to determine whether the information can increase the possibility of abuse-deterrent labeling for KP201/APAP.

KemPharm went public as recently as April 16, 2015, priced at $11.00 per share. The stock closed Thursday's trading at $11.87, up 3.04%.

Keeping in view of the expanding research and commercial business operations, Osiris Therapeutics Inc. (OSIR) is evaluating the establishment of an international, ex-U.S. Subsidiary either in United Kingdom, Singapore or Switzerland.

In the first quarter of 2015, the company's product revenues were $21.0 million compared to $10.1 million in the first quarter of 2014, an increase of 109%.

OSIR closed Thursday's trading at $18.36, down 0.76%.

Shares of Otonomy Inc. (OTIC) were down more than 18% in extended trading on Thursday after the company announced that its phase IIb trial of OTO-104 in patients with unilateral Ménière's disease narrowly missed achieving statistical significance.

Ménière's disease is a chronic condition that is characterized by acute vertigo attacks (extreme dizziness), tinnitus (ringing of the ear), fluctuating hearing loss, and a feeling of aural fullness.

The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. In the topline analysis, OTO-104 demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo with a p value of 0.067.

The company plans to request an End-of-phase II meeting with the FDA and intends to initiate two parallel phase III trials in Ménière's disease with the first trial beginning by the end of 2015.

OTIC closed Thursday's trading at $31.05, down 1.90%. In after-hours, the stock fell another 18.29% to $25.37.

Vical Inc. (VICL) has completed enrollment in a phase II trial of its therapeutic cytomegalovirus vaccine, ASP0113, in solid organ transplant recipients, almost a year ahead of schedule. A total of 150 kidney transplant recipients have been enrolled, exceeding the original enrollment target of 140.

Topline trial results are expected in the second half of 2016.

Vical licensed ASP0113, to Astellas Pharma Inc., which is conducting the phase II trial and an ongoing pivotal phase III trial in hematopoietic stem cell transplant recipients.

VICL closed Thursday's trading at $0.89, down 4.30%.