Vanda Announces Tradipitant Phase II Proof of Concept Study Results for Chronic Pruritus; Aerpio Announces Publication of Positive Results of Phase 1b/2a of AKB-9778 Print E-mail
By William Kent   
Wednesday, 04 March 2015 20:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 4, 2015.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced top-line results of the Phase II proof of concept clinical study investigating the safety and efficacy of tradipitant as a monotherapy in the treatment of chronic pruritus in patients with atopic dermatitis. Despite a highly significant and clinically meaningful improvement from baseline by tradipitant (40.5mm improvement from baseline, p<0.0001) as measured on a 100mm unit Visual Analog Scale (VAS) for itch, a very high placebo effect (36.5 mm improvement from baseline, p<0.0001) on the change from baseline led to no statistical difference from placebo. However, subsequent analysis of population PK samples across all patients in the study revealed significant and clinically meaningful responses across multiple outcomes evaluated in individuals with higher levels of tradipitant exposure at the time of their pruritus assessments.
"The results of this exploratory study are encouraging and promising; a target-specific therapy using an NK-1 receptor antagonist in severe atopic dermatitis pruritus is a novel concept and will help AD patients suffering from the symptom worldwide," said Dr. Sonja Staender, Department of Dermatology, and Head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) of the University Hospital in Munster, Germany.

Tradipitant, formerly known as VLY-686, is a neurokinin 1 receptor antagonist under clinical investigation for the treatment of chronic pruritus in patients with atopic dermatitis.  The pre-specified primary endpoint of the Phase II proof of concept clinical study was the change from baseline on the Visual Analog Scale (VAS) for itch. Due to high placebo effect, there was no significant difference from placebo on this pre-specified endpoint, however, Vanda believes this proof of concept study was informative, in that through subsequent analyses, it has discovered an exposure response relationship and further observed a significant and clinically meaningful response across several pruritus related outcomes evaluated in individuals with higher blood plasma levels of tradipitant.  This is not unexpected given that all the assessments related to pruritus are significantly associated with the itch sensation the patient is experiencing at that time. Based on the data Vanda examined across the study, lower blood plasma levels of tradipitant may be below a threshold of efficacy to ameliorate the itch sensation in patients.


 

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Aerpio Therapeutics, Inc.
, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for vascular disorders with an emphasis on diseases of the eye, today announced publication of positive results from the company’s Phase 1b/2a clinical study of lead clinical candidate, AKB-9778, a Tie2 activator. AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leakage. The Phase 1b/2a study, named “TIME-1”, showed that AKB-9778, administered subcutaneously for 28 days as monotherapy in patients with DME, was well-tolerated and produced clinically meaningful reductions in retinal thickness, correlating with improved visual acuity. The TIME-1 clinical results have been published in an article titled, “Treatment of Diabetic Macular Edema with an Inhibitor of Vascular Endothelial-Protein Tyrosine Phosphatase That Activates Tie2,” DOI: http://www.aaojournal.org/article/S0161-6420(14)00901-4/fulltext, which is appearing in the March 2015 print edition of Ophthalmology, the journal of the American Academy of Ophthalmology.

A total of 24 patients with DME participated in the 28-day, open-label, dose-escalation Phase Ib/2a trial. Cohorts of six patients each were treated with 5 mg, 15 mg, 22.5 mg and 30 mg of AKB-9778 delivered subcutaneously BID for 28 days, and patients were observed for an additional 56 days. As previously reported, all dose levels of AKB-9778 were well-tolerated, with no serious adverse events observed. After one month of treatment at doses of 15 mg or greater, 7 out of 18 patients demonstrated a reduction in central subfield thickness (CST) in the study eye of greater than 50µm, and 13 out of 18 patients gained 5 or more letters of visual acuity in the study eye as measured by the best corrected visual acuity (BCVA) assessment.

“The publication in the AAO journal is the first to demonstrate that activating Tie2, an alternative pathway to currently available anti-VEGF agents, can have a meaningful impact on both reduction in retinal edema and improved visual outcomes,” said David S. Boyer, MD, Retina-Vitreous Associates Medical Group. “Importantly, the study showed a significant correlation between measures of BCVA and CST, providing further proof of concept for this promising therapeutic modality in patients.” Based on the clinical results of the Phase 1b/2a study, in February 2014 Aerpio announced the initiation of a randomized, double-masked Phase 2 trial, named “TIME-2,” evaluating AKB-9778 alone and in combination with ranibizumab (Lucentis®), for the treatment of DME.

“We are pleased with the progress of our AKB-9778 clinical program and that we have reached the milestone of completing enrollment on schedule in the TIME-2 study,” stated Joseph Gardner, Ph.D., President and CEO of Aerpio. “We believe that AKB-9778 has the potential to profoundly impact the treatment of diabetic eye disease, both as monotherapy, as well as an adjunct to existing treatments. Based on our current timelines, we anticipate reporting topline data from the TIME-2 study sometime in the second quarter of 2015.”


 

Also Wednesday: 

 


Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, and Bell Helicopter, a Textron Inc. company (NYSE:TXT), announced today an agreement for the sale of 200 Bell 407GXPs configured for Helicopter Emergency Medical Services (HEMS).

Akorn, Inc. (Nasdaq:AKRX)
, today announced the company has adopted a comprehensive policy that endorses the use of its products to promote human health and wellness and condemns the use of its products - particularly midazolam and hydromorphone hydrochloride - in execution protocols.

Alder BioPharmaceuticals, Inc. (Nasdaq:ALDR)
, a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the fourth quarter and full year ended December 31, 2014.

Amedisys, Inc. (Nasdaq:AMED)
, a leading home health and hospice company, today reported its financial results for the fourth quarter and year ended December 31, 2014.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Richard Pascoe, Chief Executive Officer, will present at the 27th Annual Roth Conference on Tuesday, March 10, 2015, at 11:30 a.m. Pacific Time.

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 an overview of the company at the following conferences in March.

Authentidate Holding Corp. (Nasdaq:ADAT)
announced today that its Board of Directors has rescheduled the Company's annual meeting of stockholders to May 28, 2015 in Berkeley Heights, N.J.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three and 12 months ended December 31, 2014.

Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, today announced that Dr. Jamey Weichert, Chief Scientific Officer and founder, will present at the 27th Annual Roth Conference on Tuesday, March 10, 2015 at 03:30 pm PDT at the Ritz Carlton in Laguna Niguel, California.

CombiMatrix Corporation (Nasdaq:CBMX)
announced today that Mark McDonough, President and Chief Executive Officer of CombiMatrix, will present at the 27th Annual ROTH Conference at 10:30 a.m. PDT on March 11, at The Ritz Carlton in Laguna Niguel, Calif.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that it will report financial results for the fourth quarter and full year ended December 31, 2014, after the market close on Wednesday, March 11, 2015.

Coronado Biosciences, Inc., (Nasdaq:CNDO)
announced today the formation of a new subsidiary company, Checkpoint Therapeutics, Inc., to develop a portfolio of fully human immuno-oncology targeted antibodies generated in the laboratory of Dr. Wayne Marasco, MD, PhD, a Professor in the Department of Cancer Immunology and AIDS at Dana-Farber Cancer Institute (Dana-Farber).

Foundation HealthCare, Inc. (OTCQB:FDNH)
, which is an owner and operator of surgical hospitals, today announced that Stanton Nelson, the company's Chief Executive Officer will present at the ROTH Capital Partners 27th Annual Growth Stock Conference to be held at The Ritz Carlton in Dana Point, California, on March 8-11, 2015.

GeneThera Inc. (OTC:GTHR)
and Hudson Robotics Inc. announced today that they have entered into a worldwide exclusive collaboration agreement to develop the next generation of Integrated Automated Robotic Systems (IARS) molecular diagnostic platform for animal testing of Tuberculosis and Paratuberculosis.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI)
, a biopharmaceutical company, today announced that it has commenced an underwritten public offering of 4,250,000 shares of its common stock.

Jamba Juice Company (Nasdaq:JMBA)
today announced that it will host a conference call and webcast on Thursday, March 12, 2015 at 5:00 p.m. ET to review fourth quarter and full year 2014 financial results.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced the publication of Auryxia™ (ferric citrate) data and expert analyses in two peer-reviewed journals.

 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 plans to release fourth quarter and fiscal year 2014 financial results after market close on March 18th.

Matinas BioPharma Holdings, Inc. (OTCQB:MTNB)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of lipid-based prescription therapeutics for the treatment of fungal and bacterial infections, as well as metabolic/cardiovascular conditions, announced today that it will be presenting at the the 27th Annual ROTH Conference being held March 8-11, 2015, at The Ritz-Carlton, Laguna Niguel, in Dana Point, California.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced the Journal of Cutaneous Pathology published data from a pivotal clinical validation study that showed the myPath™ Melanoma test is highly effective at differentiating benign skin moles from malignant melanoma with greater than 90 percent diagnostic accuracy.

Novadaq Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, announced today that its President and Chief Executive Officer, Arun Menawat, will present an update on the Company's business at the Barclays Global Healthcare Conference on Thursday, March 12, 2015 at 11:15 a.m. Eastern Time at the Loews Miami Beach Hotel in Miami, FL.

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ajay Bansal, Chief Financial Officer, will present at the 27th Annual ROTH Conference in Laguna Niguel, CA. The presentation will take place on Wednesday, March 11th at 11:00 a.m. PT.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report year-end 2014 results on Tuesday March 17, 2015.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that Vikas Sharma, Ph.D., the Company's Director of Business Development, will present at the BIO-Europe Spring® 2015 Conference in Paris, France on Tuesday, March 10, 2015 at 2:15 PM (Central European Time).

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR)
announced today the completion of the merger with OnCore Biopharma, Inc.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, announced today an agreement with Checkpoint Therapeutics, Inc., a newly formed subsidiary of Coronado Biosciences, Inc. (Nasdaq:CNDO) to develop and commercialize Checkpoint's fully human anti-PD-L1 and anti-GITR antibody research programs in the field of hematological malignancies. 

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that Tom Kassberg, the company's Chief Business Officer, will be presenting at the Barclays Global Healthcare Conference on Wednesday, March 11, 2015 at 3:20pm ET at the Loews Miami Beach Hotel in Miami, Florida.

VBL Therapeutics (Nasdaq:VBLT)
a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class gene therapy treatments for cancer, today announced that management is scheduled to present a company overview at the following investor conferences in March:  27th Annual ROTH Conference in Dana Point, CA on Monday, March 9, 2015 at 5:30 p.m. PT.; BioCentury 22nd Annual Future Leaders in the Biotech Industry Conference in New York, NY on Friday, March 20, 2015 at 10:00 a.m. ET.

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 Barclays Global Healthcare Conference on Thursday, March 12, 2015 at the Loews Miami Beach Hotel in Miami, Florida.

WaferGen Bio-systems, (Nasdaq:WGBS)
announced today that will announce fourth quarter and fiscal year 2014 financial results after the market close and host a conference call and webcast on Monday, March 16, 2015.

Wellness Center USA, Inc. (OTCQB:WCUI)
today announced that its wholly owned subsidiary, Psoria-Shield, Inc. (PSI), will be showcasing its flagship product, the Psoria-Light, at the 73rd Annual Meeting hosted by the American Academy of Dermatology (AAD) on March 20th through March 24th, at the Moscone Center in San Francisco, California.



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