Zogenix Received FDA Approval; Pluristem Announces Significant New Finding from Its Phase I/II Muscle Injury Trial Print E-mail
By William Kent   
Monday, 02 February 2015 20:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 2, 2015.
The new version of Zogenix, Inc.'s (NASDAC: ZGNX) Zohydro ER utilizes BeadTek, which has abuse-deterrent properties. The company has ongoing Human Abuse Liability studies that will be submitted to the FDA in the second half of 2015.  The company hopes that they will be able to amend the labeling on the current Zohydro ER label. 

On January 30, Zogenix, Inc. (NASDAC: ZGNX) received FDA approval for its reformulated version of Zohydro ER.

Zogenix has stated that it expects to roll out the new formulation of Zohydro ER in the second quarter. It is likely that the company announces a secondary offering in the near future to fund the rollout.  On January 20, the company put its S-3 into EFFECT. Under the S-3, the company has the ability to raise up to $100 million through a secondary public offering with Cantor Fitzgerald.  According to most recent filings, the company has about $50 million in cash and burns about $80 million.

Long-term, a successful rollout could be a positive, as the new formulation has the potential to bring in larger revenues.  The company is also developing Brabafen for Dravet syndrome and Relday for schizophrenia.  At the time of approval, approximately 15.5 percent of the float was held short.  On December 29, Brean Capital put a $2.50 price target on Zogenix stock.



 
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Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI)
, a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227). Pluristem further announced positive twelve-month safety data from the trial. These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints. The primary efficacy finding was the change in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg at six months after total hip replacement. There was a large and statistically significant improvement in patients who were injected with 150 million cells versus those who received placebo (31.1 vs 5.4 Nm, p=0.0067).


The study's Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité – Universitaetsmedizin Berlin, Germany, commented "I am impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and
these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality."


Zami Aberman, Chairman and

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CEO, stated "It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and
also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX-PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation."


The Phase I/II trial was a randomized, double blind, placebo controlled study conducted at the Orthopedic Clinic of the Charité – Universitaetsmedizin Berlin jointly with the Berlin-Brandenburg Center for Regenerative Therapies under the auspices of the Paul-Ehrlich-Institute (PEI), Germany's health authority. The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty using the transgluteal approach. Post-operative healing is crucial for joint stability and function. The 20 patients in the study were randomized into three treatment groups. Each patient received injections in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells (n=7), the second was administered 300 million PLX-PAD cells (n=6), and the third received placebo (n=7). The primary efficacy endpoint was clearly met and the safety profile at 12 months was excellent.


 
Also Monday:


AB Science SA (NYSE Euronext - FR0010557264 - AB)
, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), today announced encouraging efficacy and safety results from a phase 2 study with its investigational drug, masitinib, in patients with nonresectable, metastatic esophagogastric adenocarcinoma after progression to first-line treatment.

Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will present at the 17th Annual BIO CEO & Investor Conference on Monday, February 9th, 2015, at 3:30 p.m. Eastern Time.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced that it will report its financial results for the fourth quarter and fiscal year ended December 31, 2014 before the market open, and will host a corporate update conference call and webcast on Thursday, February 12 at 8:30am Eastern Time.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that novel data on its lead product candidate, NS2, has been accepted for two poster presentations at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting, being held May 3-7, 2015 in Denver, Colorado.

Alliqua BioMedical, Inc. (Nasdaq:ALQA)
, a provider of advanced wound care products, today announced that it has signed a definitive agreement to acquire Celleration, Inc. ("Celleration") for an initial purchase price of approximately $30.4 million, which is comprised of both cash and stock.

Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP)
, a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, today announced that it has reached its target enrollment in the Phase 2 FLAGSHIP trial of AQX-1125 for the treatment of chronic obstructive pulmonary disease (COPD) following a recent exacerbation.

Ascendis Pharma A/S (Nasdaq: ASND)
, a clinical stage biopharmaceutical company, today announced the closing of its initial public offering of 6,900,000 American Depositary Shares (ADSs) at a price to the public of $18.00 per ADS, which includes the exercise in full by the underwriters of their option to purchase additional ADSs.

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 Pratik Shah, Ph.D., president and chief executive officer, will present at the 2015 Leerink Global Healthcare Conference on Thursday, February 12, 2015 at 2:40 p.m. EDT at the Waldorf Astoria in New York City.

Cerner Corporation (Nasdaq:CERN)
, a health care IT company, will visit the Nasdaq MarketSite in Times Square. Cerner is committed to helping shape the future of health care through innovation and is focused on key development areas including population health, physician experience, interoperability, revenue cycle and mobility.

Codexis, Inc. (Nasdaq:CDXS),
a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced that President and CEO John Nicols and Senior Vice President and CFO Gordon Sangster will present at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015, at 3:00 p.m. Eastern Time (12:00 p.m. Pacific Time).

Digirad Corporation (Nasdaq:DRAD)
today announced a quarterly cash dividend of $0.05 per share.

Esperion Therapeutics, Inc. (NASDAQ: ESPR)
, an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardio-metabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the peroxisome proliferator-activated receptor (PPAR) partial clinical hold on ETC-1002.

Flexion Therapeutics, Inc. (Nasdaq:FLXN)
today announced dosing of the first patient in the Phase 3 clinical trial of its lead drug candidate FX006 as a treatment for pain associated with osteoarthritis (OA) of the knee. FX006 is Flexion's novel, non-opioid, sustained-release, intra-articular (IA or within the joint) formulation of triamcinolone acetonide (TCA).

GreeneStone Healthcare Corporation (OTCBB:GRST)
, a provider of healthcare services including addiction and mental health, has finalized the terms for the acquisition of the property currently leased by the Company.

Heat Biologics, Inc.  (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today outlined its 2015 corporate objectives and reviewed the Company's 2014 accomplishments.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, announced today the results of a new efficacy study of Ampligen® in a mouse model of Ebola virus (EBOV) infection performed by scientists at the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID).

Histogenics Corporation (Nasdaq:HSGX)
, a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the appointment of David Gill to its board of directors and chairman of the audit committee.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI)
, a biopharmaceutical company focused on the development of therapeutics for central nervous system ("CNS") disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, will participate in a fireside chat at the 2015 Leerink Global Healthcare Conference in New York City at the Waldorf Astoria.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the industry leader in robotic-assisted surgery, today announced that its Board of Directors has authorized the Company to repurchase up to $1.0 billion of the Company's outstanding common stock.

Inovio Pharmaceuticals, Inc. (Nasdaq:INO)
announced today that President and CEO, Dr. J. Joseph Kim, will present a corporate overview at the 22nd Annual Emerald Groundhog Day Investment Forum on Thursday, February 5th at 2:45 PM ET.

Kite Pharma, Inc., (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that Arie Belldegrun, M.D., FACS, Kite's President and Chief Executive Officer, will present a corporate overview at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015 at 1:30 p.m. Eastern Time at the Waldorf Astoria in New York City.

Luminex Corporation (NASDAQ: LMNX)
today announced financial results for the fourth quarter and year ended December 31, 2014. 

mCig, Inc. (OTCBB:MCIG)
, a technology leader in portable and home vaporizers and extraction equipment, is very pleased to announce the expansion into the development, manufacturing, and marketing of CBD Hemp Oil-derived products. Cannabidiol (CBD) is one of several new vertically integrated initiatives recently announced as part of mCig's diversification strategy, which also includes legal medical/recreational cannabis extracts, nicotine substitutes, and other emerging nutraceutical product categories.

MediciNova, Inc. (Nasdaq:MNOV)
and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that an abstract regarding MediciNova's ongoing clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis) has been accepted for dual presentation at the American Academy of Neurology (AAN) 67th Annual Meeting to be held April 18 - 25, 2015 in Washington, DC.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that following discussions regarding the future development of rigosertib with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and several European national regulatory agencies, the Company has solidified its plans for a Phase 3 clinical trial for rigosertib in HR-MDS patients after failure of treatment with HMAs.

PharmaCyte Biotech, Inc. (OTCQB:PMCB)
, a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live cell encapsulation technology, Cell-in-a-Box®, today reported that the first preclinical evaluation of its proprietary Melligen cell line for the treatment of diabetes has commenced in the Institute of Virology, Department of Pathobiology, at the University of Veterinary Medicine in Vienna, Austria.

Premier, Inc.'s (Nasdaq:PINC)
TheraDoc® clinical surveillance system has been named the best-performing clinical surveillance solution by KLAS, an independent healthcare research firm.

Recro Pharma, Inc. (Nasdaq:REPH)
, a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of acute post operative pain, today announced that Gerri Henwood, the Company's President and Chief Executive Officer, will present at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015, at 11:00 am EST.

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus, will present a company overview at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015 at 1:30 pm EST and at the 4th Annual Leerink Partners Global Healthcare Conference on Wednesday, February 11, 2015 at 3:55 pm EST. 

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that John A. Orwin, president and chief executive officer, will present at the 17th Annual BIO CEO & Investor Conference on February 10, 2015 at 9:00 a.m. ET.

Signal Genetics, Inc. (Nasdaq:SGNL)
, a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced the U.S. Federal Drug Administration (FDA) conditionally approved its proprietary prognostic genetic test, MyPRS (Myeloma Prognostic Risk Signature®), for use as entry criteria for an upcoming clinical trial to treat high-risk multiple myeloma (MM) patients sponsored by the University of Arkansas for Medical Sciences (UAMS).

StemCells, Inc. (Nasdaq:STEM)
announced today that Management will make a presentation on the Company's programs and operations at the 17th Annual BIO CEO & Investor Conference. Management is scheduled to speak at 8:30 a.m. EST on Monday, February 9, at the Waldorf Astoria in New York City.

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 that Jeffrey L. Cleland, PhD, Chief Executive Officer, is scheduled to present at the 2015 BIO CEO & Investor Conference on Tuesday, February 10, 2015 at The Waldorf Astoria in New York City.

Wright Medical Group, Inc. (Nasdaq:WMGI)
today announced that on January 28, 2015 it received from the Federal Trade Commission ("FTC") a Request for Additional Information and Documentary Material (commonly known as a "Second Request") in connection with its proposed merger with Tornier N.V. Wright also announced that the previously disclosed pending pre-approval inspection of an Augment Bone Graft vendor had concluded and resulted in the issuance of a Form 483 containing certain observations to which the vendor has already responded.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that it intends to commence an underwritten public offering of $75,000,000 of shares of its common stock. All of the shares in the proposed offering are to be sold by ZIOPHARM.



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