Minerva Reports Positive Phase 1 Data With MIN-202; Integra Launches Integra(R) Reinforcement Matrix Print E-mail
By Josh Gee   
Wednesday, 21 January 2015 19:57
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 21, 2015.
Minerva Neurosciences, Inc. (Nasdaq:NERV) announced preliminary results from a Phase 1 clinical study showed that treatment with MIN-202, a selective orexin-2 antagonist, resulted in significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorder (MDD). Preliminary results from two additional Phase 1 studies also suggest that MIN-202 is well tolerated and possesses advantageous pharmacokinetic and pharmacodynamic features. The three Phase 1 studies were conducted by Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, as part of a collaboration to develop MIN-202 with Minerva that was facilitated by Johnson & Johnson Innovation Ltd in London.

"Treatment of sleep disorders remains a significant challenge in patients with both primary insomnia and many CNS diseases. These positive data indicate that MIN-202 could be an effective treatment able to both induce and maintain sleep," said Remy Luthringer, PhD, president and CEO of Minerva, adding "With these findings we have identified a dose range to advance this compound."

In patients with mood disorders, sleep disturbances (both insomnia and hypersomnia) have been associated with a suboptimal response to antidepressant drug (AD) therapy, an increased risk for relapse (in AD-responsive patients), and prodromal depression. Recent studies have shown that orexin-2 receptor antagonism might have a beneficial effect on overall arousal and stress level.

"We are especially encouraged by findings that support the use of MIN-202 in the treatment of both primary insomnia as well as sleep disorders associated with MDD," Dr. Luthringer added.

MIN-202 Phase 1b Study in MDD Patients -- This was a double-blind, placebo-controlled, randomized, four-way crossover, single dose study in 20 male and female patients with MDD and insomnia. The primary endpoint was the effect of MIN-202 (dosed PM) on latency to persistent sleep (LPS). Some additional endpoints were evaluated by PSG (polysomnography). Preliminary results demonstrated a statistically significant effect on LPS in all three doses tested (10, 20, and 40 mg). Treatment with MIN-202 also resulted in prolonged total sleep duration by approximately 45 minutes.

MIN-202 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers -- This was a double-blind, placebo-controlled, randomized MAD study in sequential cohorts of healthy males and females. MIN-202 was administered in the morning at dose levels ranging from 5mg to 60mg for 10 days. A dose level as low as 5mg was shown to elicit sedation while dose levels ≥ 20mg induced (daytime) somnolence. MIN-202 plasma exposure was dose proportional from 5mg to 20mg. At higher doses, the exposure was less than dose proportional.

MIN-202 Phase 1 Bio-Availability (BA) Study -- The two studies described above were carried out using a suspension formulation of MIN-202. This third study evaluated treatment with a solid dose formulation of MIN-202 to potentially support additional clinical studies. In this study, similar pharmacokinetic profiles were observed for both formulations, qualifying the solid dose to support further clinical studies.   In these Phase 1 studies, MIN-202 was found to be generally well tolerated.


 
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Integra LifeSciences Holdings Corporation (Nasdaq:IART)
announced the full market release of Integra® Reinforcement Matrix, a biological implant composed of porcine dermis that may be used for any type of tendon injury that requires surgical reconstruction. Tendon injuries are some of the most common musculoskeletal disorders, ranging from a mild ankle sprain to an Achilles tendon rupture or flexor tendon injury of the hand.

Manufactured by Stellen Medical, which has over 25 years' experience in working with porcine dermis, the matrix has 510 (k) clearance from the Food and Drug Administration, and is made of the same material that has over 14 years of implant success in more than 40,000 surgical procedures.

"Integra is committed to providing improved clinical solutions for our upper and lower extremity surgeon customers," said Bill Weber, Vice President, Orthopedics & Tissue Technologies. "Integra Reinforcement Matrix complements our portfolio of tendon repair products, and offers surgeons enhanced options for their patients' needs."

Integra Reinforcement Matrix has high tensile strength that provides durable reinforcement during the healing phase of a repaired tendon, and omni-directional suture pullout strength that minimizes tearing.  The collagen matrix allows early cellular repopulation, remodeling and revascularization for long- term repair. The product is available in two convenient sizes, 4 cm X 7 cm and 5 cm X 10 cm, and is ready-to-use, hydrated, and does not require special handling before surgery.


 
Also Wednesday: 




Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced that it has commenced an underwritten public offering of 4,000,000 shares of its common stock.

BioMed Realty Trust, Inc. (NYSE:BMR)
today announced it will report results for its fourth quarter and year ended December 31, 2014 after the market closes on Wednesday, February 4, 2015.

Capricor Therapeutics, Inc. (OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases and CureDuchenne, a national nonprofit organization dedicated to finding a cure for Duchenne muscular dystrophy, invite participants to join a webinar on Wednesday, January 21, 2015 at 3:00 p.m. ET/12:00 p.m. PT.

Cerner Corp. (Nasdaq:CERN)
and the Veterans of Foreign Wars (VFW), the nation's largest organization of combat veterans, have collaborated to support service members during and after their service.

Curis, Inc. (Nasdaq:CRIS)
, a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, and Aurigene Discovery Technologies Limited, a specialized, discovery stage biotechnology company developing novel therapies to treat cancer and inflammatory diseases, today announced that they have entered into an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets.

Epicore BioNetworks Inc. (TSX-V:EBN)
announces that it has granted stock options to non-executive directors, officers and to employees of the company.

ERBA Diagnostics, Inc. (NYSE MKT:ERB)
, has attained CE Mark clearance for the HB Vario A1c detection system and associated reagents.

Gala Global, Inc. (OTCQB:GLAG)
today announced that internationally recognized energy entrepreneur Erlend Olson and highly accomplished Pharmaceutical, Biotechnology and Medical Device expert Russell Anderson have joined the Gala Global Board of Directors.

Herborium® Group, Inc. (OTC Pink: HBRM)
, a Botanical Therapeutics® Company providing unique, all botanical medicines (Botanical Therapeutics®), announced today that the Company's CEO, Dr. Agnes P. Olszewski has been interviewed live by Michael Yorba, the host,  "The Trader's Network" Show on January 17th, 2015.

Immune Pharmaceuticals (NASDAQ: IMNP)
announced today that the Board of Directors has appointed Gad Berdugo as Executive Vice President and Chief Financial Officer and has appointed Cameron Durrant, MD, MBA, as Lead Independent Director and Chairman of the Compensation Committee.

India Globalization Capital, Inc. (NYSE-MKT: IGC)
announced that it has received a business license from the state government of Karnataka, India, to expand its infrastructure heavy equipment rental business.

IRADIMED CORPORATION (Nasdaq:IRMD)
announced today that the Company will release its 2014 fourth quarter financial results before the market opens on Thursday, February 5th.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MESA® 2 Deformity Spinal System.

Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB),
the leading developer of advanced spider silk based fibers, announces Jon Rice as the new Chief Operations Officer effective immediately.

Minerva Neurosciences, Inc. (Nasdaq:NERV)
today announced it has entered into a $15 million debt facility with Oxford Finance LLC (Oxford) and Silicon Valley Bank (SVB).

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that it will issue financial results for the fiscal second quarter 2015 and provide a business update following the close of market on Tuesday, February 3, 2015.

Oculus Innovative Sciences, Inc. (Nasdaq: Common Stock – OCLS, Warrants – OCLSW)
today announced the pricing of an underwritten public offering of 6,250,000 shares of common stock, and warrants to purchase an aggregate of 4,687,500 shares of common stock, at an offering price of $1.00 per share and related warrant.

Otonomy, Inc. (Nasdaq:OTIC)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the launch of its proposed follow-on public offering of approximately $75 million of its common stock.

Repligen Corporation (Nasdaq:RGEN)
announced today that its Board of Directors has appointed Tony J. Hunt to be the Company's next Chief Executive Officer.

Shire PLC (NASDAQ: SHPG)
announces that it has for the first time placed in the Global 100 Sustainability Index.

Sigma-Aldrich Corporation (Nasdaq: SIAL)
was named today to the 2015 Global 100 Most Sustainable Corporations in the World (Global 100) Index, a recognition that identifies the top overall sustainability performers in their respective industrial sectors.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
, a global biopharmaceutical company, today announced that Robert J. Spiegel, M.D., FACP has joined Sucampo's Board of Directors.

Zafgen, Inc. (Nasdaq:ZFGN)
today announced that it has commenced an underwritten public offering of 2,840,909 shares of its common stock.



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