NeuroBioPharm's Shareholders Approve Arrangement With Neptune; Aileron Initiates Phase 1 Cancer Study of ALRN-6924 Print E-mail
By Marilyn Mullen   
Thursday, 12 February 2015 19:33
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 12, 2015.
NeuroBioPharm Inc., a subsidiary of Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announces that its shareholders (the "Shareholders") approved a resolution today authorizing the previously announced plan of arrangement (the "Arrangement") providing for, among other things, the indirect acquisition by Neptune of all of the issued and outstanding shares of NeuroBio.

The Arrangement resolution required the approval of at least two-thirds of the votes cast by the Shareholders holding all classes of shares of NeuroBio, voting separately as classes, in each case present in person or represented by proxy at the special meeting of Shareholders held today.

The Arrangement resolution was approved by (i) 96.95% of the votes cast by Shareholders holding Class "A" Shares of NeuroBio, (ii) 90% of the votes cast by Shareholders holding Class "B" Shares of NeuroBio, (iii) 90% of the votes cast by Shareholders holding Class "G" Shares of NeuroBio, and (iv) 90% of the votes cast by Shareholders holding Class "H" Shares of NeuroBio.

The Arrangement is also subject to the approval of the Superior Court of Québec at a final hearing which is scheduled to be held on February 16, 2015 at the Montréal Courthouse in Montréal, Québec at 9:15 a.m. (Montréal time) or as soon thereafter as counsel may be heard. It is anticipated that the Arrangement will be completed shortly thereafter once all closing conditions have been satisfied or waived, including without limitation, court approval set forth above.



 
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Aileron Therapeutics, Inc., a clinical stage biopharmaceutical company that is the leader in the emerging field of stapled peptide drug development, announced today that the first cancer patients have been dosed in a Phase 1 clinical trial of ALRN-6924.

ALRN-6924 is a potent and specific re-activator of wild type p53, a tumor suppressor protein that has been long referred to as “the guardian of the genome.” P53 represents one of the most sought after oncology drug targets by clinical oncologists due to its central role in preventing the initiation and progression of most liquid and solid tumors. ALRN-6924 is the first clinical drug candidate that binds equipotently and inhibits both of the p53 suppressor proteins, MDM2 and MDMX, in contrast to other p53-targeting small molecule drugs in clinical development that only inhibit MDM2.

“This clinical study represents a very ambitious undertaking for Aileron and is an exciting time for our team and collaborators. The ultimate goal of this trial is to demonstrate our ability to safely and effectively engage one of the most important targets in all of oncology, p53, and further establish the druggability of transcription factors that have been shown to be some of the most important but difficult-to-target oncogenic drivers. Per our stapled peptide platform, this study will demonstrate the first systemic administration of a cell-penetrating stapled peptide and will further establish the potential of this new class of medicines for a wide range of therapeutic areas,” said Joseph A. Yanchik III, President and Chief Executive Officer of Aileron Therapeutics.

“It is estimated that over 10 million people are living with a cancer that has wild type p53 signaling inactivated. Our ability to directly engage the full mechanism with ALRN-6924 could have unprecedented impact not only in treating a broad range of liquid and solid tumors that test positive for wild type p53, but our drug could also expand the efficacy of many current therapies that rely on a functional p53 pathway,” said Dr. Manuel Aivado, Chief Medical Officer of Aileron Therapeutics. “With the Phase 1 study well underway, we expect to have a steady flow of important insights into the safety and activity of ALRN-6924 in patients throughout the year.”

About the Phase 1 Study - The Phase 1, multicenter, dose-escalation study of ALRN-6924 is intended to assess the safety and tolerability of ALRN-6924 as a single agent. The study is expected to enroll cancer patients with advanced hematologic and solid malignancies that test positive for the presence of wild type p53. The objectives of the trial include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics (including showing the inhibition of MDM2 and MDMX and the re-activation of p53) and preliminary indications of anti-tumor activity. The study design also provides for tumor specific expansion cohorts that will test the maximally tolerated or optimal biological dose.

About P53 and ALRN-6924 - P53 is known as “the guardian of the genome” because it is the body’s cellular first line of defense that enables the repair of damaged DNA or, if unsuccessful, triggers cell death. It is one of the most studied and pursued tumor suppressor proteins, as it is known to be inactivated in virtually all human cancers. As half of all cancers circumvent p53’s protective mechanisms by the inhibitory proteins MDM2 and MDMX, Aileron’s stapled peptide, ALRN-6924, is novel in that it can selectively bind to and inhibit both proteins equally, thereby restoring p53 function and the cancer cell’s ability to trigger its innate cell death mechanism.



Also Thursday:


Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced that the Company will host a conference call and live audio webcast at 5:00 p.m. EST on Thursday, February 26, 2015, to provide a business update and to discuss its fourth-quarter and full-year 2014 financial and operating results.

Amedica Corporation (Nasdaq:AMDA)
, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it has filed a submission for 510(k) clearance of the Valeo C Interbody with CsC Osteo-Conductive Scaffolding ("Valeo CCsC") with the U.S. Food and Drug Administration ("FDA") relating to its composite silicon nitride spinal interbody devices.

A new study about end-of-life care may be only about half right, asserts Michael Fleming, MD, FAAFP and chief medical officer for Amedisys Inc. (Nasdaq:AMED), a national leader in healthcare at home and hospice.

Atara Biotherapeutics, Inc. (Nasdaq:ATRA)
, a biopharmaceutical development company with a focus on innovative therapies for patients with debilitating diseases, today announced the pricing of its underwritten public offering of 3,638,333 shares of its common stock at a public offering price of $18.00 per share.

AXIM Biotechnologies, Inc. (OTC:AXIM)
, an industry leader in cannabinoid research and commercial hemp product development, is proud to announce that it is launching a hemp-based Oral Care Division.

Axxess Pharma Inc. (OTC PINK: AXXE)
, a specialty pharmaceutical and nutritional supplements company, through its wholly owned subsidiary, AllStar Health Brands Inc., is pleased to announce sales of its popular TapouT product line has now expanded into Thailand.

BioTelemetry, Inc. (Nasdaq:BEAT)
will release its fourth quarter 2014 earnings on Thursday, February 19, 2015 at 4:00 PM Eastern Time.

BioReference Laboratories, Inc. (Nasdaq:BRLI)
announced today the formation of a new business group — the Commercial Collaborations and Innovations ("CCI") Group.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that CEO and President Panna Sharma will participate in the BTIG Second Annual Snowbird Medical Technology, Diagnostics, and Healthcare IT Conference from February 18th to 20th.

Cerner Corp. (Nasdaq:CERN)
, one of the largest health information technology suppliers, and development partner Mortara Instrument, a leading U.S. manufacturer of diagnostic cardiology instrumentation, including multi-parameter patient monitoring, have joined together to introduce CareAware Waveform Management™.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, today reported financial results for the second quarter of fiscal 2015 and provided an update on the progress of its clinical programs.

Chimerix, Inc. (Nasdaq:CMRX)
announced the presentation of preliminary data from the open-label, Phase 3 AdVise trial of brincidofovir for adenovirus infection showing a short-term mortality rate of less than 40 percent.

Emergent BioSolutions Inc. (NYSE:EBS)
will host a conference call on Thursday, March 5, 2015 at 5:00 pm (Eastern Time) to discuss the financial results for the fourth quarter and full twelve months of 2014, recent business developments, financial outlook for full year 2015, and revenue guidance for the first quarter of 2015.

Eyegate Pharmaceuticals, Inc. (OTCQB:EYEGV),
a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced the pricing of its initial public offering of 683,250 shares of its common stock, offered at a price to the public of $6.00 per share.

Foundation Healthcare Inc. (OTCQB:FDNH)
, an owner and operator of surgery focused hospitals that facilitate and enhance the surgical experience for surgeons and their patients, announced today it will host an earnings call to discuss the Company's fourth quarter and full fiscal year 2014 financial results at 9:00 a.m. EST (8:00 a.m. CST) on Wednesday, February 25, 2015.

Gevo, Inc. (Nasdaq:GEVO)
announced today that it has appointed Andy Marsh to its Board of Directors. Mr. Marsh is the President and Chief Executive Officer of Plug Power Inc. (Nasdaq:PLUG), the leading designer and manufacturer of commercially viable hydrogen and fuel cell systems.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
and the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) will present findings of new studies of Ampligen® (rintatolimod), an experimental therapeutic, performed by USAMRIID scientists in models of Ebola virus infection.

Histogenics Corporation (Nasdaq:HSGX)
, a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced it will release its financial and operational results for the fourth quarter and full year ended December 31, 2014 on February 26, 2015 before the market opens.

Immunomedics, Inc., (Nasdaq:IMMU)
announced today the closing of its previously announced offering of 4.75% Convertible Senior Notes due 2020 (the "Convertible Notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").

K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced the closing of the sale of 906,748 shares of common stock by certain of the selling stockholders in the Company's follow-on offering pursuant to the underwriters' option to purchase additional shares, at a price of $18.75 per share before underwriting discounts. K2M did not receive any proceeds from the sale of these shares.

mCig® Inc. (OTCBB: MCIG)
, a cannabis-related holdings and incubation company, announces the launch of its general construction and engineering design division, highlighted by the signing of a partnership agreement with ClimaGrow by Elkins.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced that the company will host its Fourth Quarter 2014 Investor Conference Call and webcast at 8:30 a.m., Eastern time, on Thursday, February 26.

Natural Health Trends Corp. (OTCQB:NHTC)
, a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced that its shares of common stock have been approved for listing on the Nasdaq Capital Market. Trading on the Nasdaq Capital Market is expected to commence on Tuesday, February 17, 2015, and the Company's common stock will continue to trade under the symbol "NHTC."

Neothetics, Inc. (Nasdaq:NEOT)
, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the creation of a corporate advisory board composed of leading plastic surgeons, dermatologists and other physicians.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that enrollment has begun in a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M™ (Ebola GP Vaccine) in healthy subjects.

NXP Semiconductors N.V. (Nasdaq:NXPI)
, a leader in the secure connected car, is pleased to announce that Stella, the world's first solar-powered family car project, took home the prestigious "Best Technology Achievement" award at the 8th annual Crunchies Awards, hosted by TechCrunch.

Oculus Innovative Sciences, Inc. (Nasdaq: Common Stock-OCLS and Warrants-OCLSW)
today announced financial results for the third quarter of fiscal year 2015, which ended on December 31, 2014.

PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, today announced that it has achieved a significant milestone in the development of its handheld Firefly Dx system with the completion of the build of its breadboard PCR (polymerase chain reaction) chip.

Premier, Inc.'s (Nasdaq:PINC)
performance improvement methodology has helped hospitals in its QUEST® collaborative realize mortality rates as much as 10 percent lower than a national comparison of hospitals not participating in QUEST, according to a new study published in the Journal of Patient Safety.

Precision Optics Corporation, Inc. (OTCQB:PEYE)
today announced that it intends to release its financial results for the fiscal 2015 second quarter ended December 31, 2014 after market trading ends on Tuesday, February 17, 2015.

Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX)
, announced today that additional positive interim data from the Company's phase I/II dose-ranging clinical trial of PRX-102 for the treatment of Fabry disease will be presented on February 12, 2015 at 10:45 AM ET at the Lysosomal Disease Network WORLD Symposium in Orlando, FL.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that Dror Ben-Asher, RedHill's Chief Executive Officer, will be presenting at the Life Sciences Israel™ 2015 3rd Annual International Partnering Conference on Thursday, February 19, 2015, at 11:30am IST, at the Dan Panorama Hotel, in Tel-Aviv, Israel.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, announced today that the Company will release fourth quarter and full year 2014 financial results on Monday, March 2, 2015 after the close of market.

Sunshine Heart, Inc. (Nasdaq:SSH)
, today announced that on February 11, 2015, the Compensation Committee of its Board of Directors, which is composed entirely of independent directors, approved one equity award under Sunshine Heart's New-Hire Equity Incentive Plan, as a material inducement to one individual entering into employment with the Company.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, today announced that Dr. Mark J. Murray, Tekmira's President and CEO, will present a company overview at the 2015 RBC Capital Markets' Healthcare Conference on Tuesday, February 24, 2015 at 12:05 – 12:30 pm (PT) / 3:05 pm – 3:30 pm (ET) at The New York Palace Hotel in New York.

TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ),
a global bacteria decontamination and infectious disease control company, is pleased to announce that the Company's proposal "SteraMist Mobile Decontamination Chambers" is one of 15 proposals selected for award by the U.S. Agency for International Development ("USAID"), in the global fight to eradicate Ebola and strengthen local healthcare systems.

VBI Vaccines (Nasdaq:VBIV)
is pleased to announce its sponsorship support of the Utah CMV Council and the End CMV Silence Gala, a fundraiser being held at the Utah State Capitol Building in Salt Lake City on February 27th, 2015.

VeriTeQ Corporation (OTC Markets: VTEQD)
, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that that it has executed a term sheet with Establishment Labs, S.A., ("EL").

Versartis, Inc. (Nasdaq:VSAR)
, an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced financial results for the fourth quarter and full year ended December 31, 2014.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that the underwriters for its recently announced underwritten public offering of common stock have exercised in full their option to purchase an additional 1,500,000 shares of common stock at a public offering price of $8.75 per share.




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