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San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.

Human liver tissue is latest in 3D printing

November 18, 2014 – 8:19 am | Edit Post

San Diego biotech’s 3D tissue functions for at least 42 days.

Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation Implant

November 18, 2014 – 7:01 am | Edit Post

CARLSBAD, CALIFORNIA–(Marketwired – Nov. 18, 2014) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51T, Aurora Spine’s slimmest minimally invasive interspinous fixation implant for spinal fusion.

HedgePath Pharmaceuticals Files IND Application

November 18, 2014 – 7:00 am | Edit Post

TAMPA, Fla. and SAN DIEGO, Nov. 18, 2014 /PRNewswire/ – HedgePath Pharmaceuticals, Inc. (OTCQB: HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today that it filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) on Friday, November 14, 2014. 

The IND covers HPPI’s proposed clinical development of a patented formulation of the currently marketed anti-fungal drug itraconazole (known as SUBA-Itraconazole) for the treatment of basal cell carcinoma (BCC) in patients with basal cell carcinoma nevus syndrome (BCCNS).

The filing follows a pre-IND meeting held with FDA at which HPPI reviewed potential Phase II(b) trial considerations in order to gain FDA input on its clinical development strategy and protocol which HPPI now believes is reflected in its IND filing.  If the IND is approved, HPPI would expect to commence patient recruiting to begin its clinical trial in the first quarter of 2015.

Nicholas J. Virca, HPPI’s President and Chief Executive Officer, commented that, “This is a milestone moment for HPPI as we submit our first IND under which we will seek to repurpose our licensed, patented formulation of the FDA approved anti-fungal drug itraconazole as a candidate for anti-cancer therapy in humans.  Based on existing third party data, we believe that itraconazole has the potential to inhibit the Hedgehog (Hh) Pathway, a major regulator of many fundamental cellular processes, which could in turn impact the development and growth of certain cancers.  We believe this could serve as a treatment for skin, lung and prostate cancers, and we will begin to develop this approach with human testing for BCC tumor response in patients with BCCNS.”  

“We believe BCCNS provides us with an ideal first opportunity to test itraconazole’s anti-cancer potential” continued Mr. Virca.  “This is a relatively well-defined patient population that suffers from multiple tumors which can be debilitating and often require disfiguring surgeries to remove cancerous lesions.  Existing topical therapies have proven suboptimal due to lack of efficacy, and the only approved oral therapy for BCC has a significant side-effect profile.  As such, we look forward to continuing our interactions with FDA, as we work to see this IND approved to study the safety and efficacy of SUBA-Itraconazole in these patients.”

Industry sources estimate that there are approximately 10,000 patients in the United States with BCCNS, which could potentially qualify SUBA-Itraconazole under the FDA’s Orphan Drug Designation Program for treatment of BCC in this patient population.  Nearly all individuals with BCCNS carry a mutation in the PTCH1 gene that results in constitutive activation of the Hh pathway.  Itraconazole has been shown to inhibit the Hh pathway which plays an important role in basal cell carcinomas. Basal cell carcinoma is a skin cancer that commonly develops on sun exposed areas of fair-skinned individuals. BCC is generally a slow-growing tumor that does not metastasize (rate of metastasis estimated at no higher than 0.5%); however, it is locally invasive and can result in severe morbidity, especially in those patients with BCCNS who can develop hundreds or thousands of BCCs requiring frequent surgical intervention.

About HedgePath Pharmaceuticals

HedgePath Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that is seeking to repurpose the FDA approved antifungal pharmaceutical itraconazole as a potential treatment for cancer.  HPPI is the exclusive U.S. licensee of a patented formulation of itraconazole, called SUBA-Itraconazole, which clinical studies have shown to have greater bioavailability than generic itraconazole.

The Hedgehog signaling pathway is a major regulator of cellular processes in vertebrates, including cell differentiation, tissue polarity and cell proliferation.  Based on published research, HPPI believes that inhibiting the Hedgehog pathway could delay or possibly prevent the development of certain cancers in humans.  Leveraging research undertaken by key investigators in the field, HPPI plans to explore the effectiveness of SUBA-Itraconazole as an anti-cancer agent and to pursue its potential commercialization.  HPPI has offices in Tampa, Florida and San Diego, California.  For more information, please visit www.hedgepathpharma.com.

About SUBA-Itraconazole

SUBA-Itraconazole is a proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble.  SUBA-Itraconazole was developed to improve absorption and significantly reduce variability compared to generic itraconazole. These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels. 

Cautionary Note Regarding Forward Looking Statements

This press release and any statements of representatives and partners of HedgePath Pharmaceuticals, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions.  These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the results of the FDA’s review of the Company’s IND as described herein and any implied timing for or results of the Company’s clinical trials) may differ significantly from those set forth in the forward-looking statements.  These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. 

For more information:

Company Contact:

HedgePath Pharmaceuticals, Inc., Nicholas J. Virca, President and CEO, nvirca@hedgepathpharma.com

Investor Relations Contact:

HedgePath Pharmaceuticals, Inc., Garrison Hasara, CFO & Treasurer, ghasara@hedgepathpharma.com

© 2014 HedgePath Pharmaceuticals, Inc.  All rights reserved.

 
SOURCE HedgePath Pharmaceuticals, Inc.

Cord Blood Registry Sponsors 2014 World Stem Cell Summit

November 18, 2014 – 7:00 am | Edit Post

SAN BRUNO, Calif., Nov. 18, 2014 /PRNewswire/ — Cord Blood Registry® (CBR®) announces that the company is a platinum sponsor of the 10th Annual World Stem Cell Summit, the largest global meeting of stem cell science and regenerative medicine stakeholders. The 2014 World Stem Cell Summit will be held December 3-5 at the Marriott Rivercenter in San Antonio, Texas.

The World Stem Cell Summit aims to advance the discovery and development of lifesaving cures and therapies, convening the most prominent figures in the field to share research, build collaborations, and achieve solutions to funding and commercialization challenges. Sessions will focus on the acceleration of stem cell science and translation into clinical trials and medical therapies for severe injury and disease, including regeneration of tissues or organs to restore or establish normal function.

“CBR’s involvement in the 2014 World Stem Cell Summit is a strong demonstration of the company’s commitment to fostering biomedical research and supporting a variety of public outreach initiatives, including patient advocacy programs,” notes Geoff Crouse, President & Chief Executive Officer of Cord Blood Registry. “As the use of cord blood continues to expand in medical applications, and research uncovers more potential for this stem cell source, educational collaborations are critical to advancing awareness and expediting the development of innovative therapeutics and treatments,” adds Crouse.

As the exclusive cord blood bank supporter of the 2014 Summit, CBR has partnered with the Genetics Policy Institute (GPI) to convene a panel discussion entitled “Banking on Cord Blood: Is the Future Here?”. The panel discussion will provide an overview of research exploring the potential of newborn stem cells in therapy for non-hematological disorders, and it will also discuss the challenges and opportunities patients and their families face when accessing research trials. The panel is scheduled for Thursday, December 4, as part of the Summit’s Translation and Clinical Trials track. The panel will feature Heather Brown, MS, CGC, Vice President of Scientific & Medical Affairs at CBR, Charles S. Cox, MD, Director of the Program in Children’s Regenerative Medicine at UT Health Science Center at Houston, Mahendra Rao, MD, PhD, Vice President for Strategic Affairs at Q Therapeutics and Vice President for Regenerative Medicine at The New York Stem Cell Foundation Research Institute, and Fran Verter, PhD, Founder & Director of the Parent’s Guide to Cord Blood Foundation.

Once regarded as medical waste, cord blood has been used in the treatment of over 80 diseases and disorders, and a growing body of research suggests that stem cells from cord blood may be used to help repair damaged or diseased tissue and organs. CBR is fueling innovation in cord blood stem cell research. CBR is the first family newborn stem cell company to partner with leading research institutions to establish FDA-regulated clinical trials exploring the potential regenerative ability of cord blood stem cells to treat acquired hearing loss, autism, cerebral palsy, and pediatric stroke.

Bernard Siegel, Founder and Co-chair of the World Stem Cell Summit, explains, “The Genetics Policy Institute recognizes the importance of expanding the scope of stem cell therapies that may be available to patients and their families. The use of cord blood derived stem cells as a therapeutic tool is integral to the future of regenerative medicine. We welcome CBR’s leadership and significant contribution to the 10th Anniversary Summit program.”

About Cord Blood RegistryCord Blood Registry® (CBR®) is the world’s largest newborn stem cell company. Founded in 1992, CBR is entrusted by parents with storing more than 500,000 cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with leading research institutions to establish FDA-regulated clinical trials, requiring CBR processed cord blood, for conditions that have no cure today. For more information, visit cordblood.com

About Genetics Policy InstituteThe Genetics Policy Institute (GPI) is a 501(c)3 non-profit organization that supports stem cell research to develop therapeutics and cures. GPI pursues its mission by producing the World Stem Cell Summit, honoring community leaders through the Stem Cell Action Awards, publishing the peer-reviewed World Stem Cell Report with Mary Ann Liebert Publishers, organizing educational initiatives, and fostering strategic collaborations. GPI maintains offices in Florida, California, and Washington DC. For more information, visit www.genpol.org
SOURCE Cord Blood Registry

Renova Therapeutics welcomes new board member, raises $7.52 million in Series C financing round

November 18, 2014 – 6:00 am | Edit Post

SAN DIEGO, Nov. 18, 2014 /PRNewswire-USNewswire/ – Renova Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, announced that Daniel M. Bradbury joined its board of directors. The company also completed its third round of funding, raising $7.52 million.

New board member brings decades of life science experience

Mr. Bradbury is a life sciences executive with more than 30 years of experience in creating transformative business strategies, bringing novel medicines to market and maximizing shareholder value. He is Managing Member of BioBrit, LLC, a Life Sciences Consulting and Investment Firm, and the former President and Chief Executive Officer of Amylin Pharmaceuticals, a biopharmaceutical company focused on metabolic diseases.

“I am excited to join the Renova Therapeutics board,” said Mr. Bradbury. “The company’s gene therapy work is transformational, and their potential for success is great.  Renova is poised to help millions of people suffering from congestive heart failure by positively impacting patient outcomes.”

Mr. Bradbury was CEO of Amylin, which was listed on the Nasdaq 100, from March 2007 until Bristol-Myers Squibb acquired the company for $7 billion in August 2012. During Mr. Bradbury’s 18 years at the company, Amylin launched the first once-a-week diabetes therapy and three other first-in-class medicines.

Mr. Bradbury received a Bachelor of Pharmacy from Nottingham University and a Diploma in Management Studies from Harrow and Ealing Colleges of Higher Education in the United Kingdom. He joins the following directors of the Renova Therapeutics board:

Jack W. Reich, Ph.D., CEO and Co-founder of Renova TherapeuticsRoy Cosan, President of Renova TherapeuticsH. Kirk Hammond, MD, Professor of Medicine, University of California, San Diego, and Co-founder of Renova TherapeuticsCraig Andrews, COO, Co-founder and Secretary of Renova TherapeuticsAndy Noorda, Managing Member of The Canopy GroupMichael Torres, CEO of Adelante Capital Management

Company now funded through 2016

Renova Therapeutics completed its third round of funding on Sept. 30, 2014, raising $7.52 million through a Series C Preferred Stock financing round. Investments in the company have come primarily from high net-worth individuals. The company is funded through 2016.

About Renova Therapeutics

There are more than 32 deaths per hour from congestive heart failure in the United States. Renova Therapeutics is working to change that.

Renova Therapeutics is a San Diego-based biopharmaceutical company and an industry leader in gene therapy, pursuing the development of treatments for congestive heart failure (CHF) and other chronic diseases. CHF is the most rapidly growing cardiovascular disorder in the United States, with an estimated six million people afflicted and 550,000 new cases diagnosed every year. Approximately 26 million patients have CHF worldwide. Renova Therapeutics, in a Public-Private Partnership with the National Institutes of Health, is currently supporting a Phase I/II trial of its novel lead therapy for patients with severe CHF (Class II, III and IV). This initial product is a single-dose gene therapy that, in animal studies, has shown substantially improved, sustained outcomes in heart failure models by safely and significantly improving myocardial function. The product is being evaluated for its safety and initial efficacy in a 3:1 randomized, double-blinded, placebo-controlled dose-ranging study involving 56 patients across seven US medical centers. The company’s product pipeline also includes a second-generation therapy for CHF patients and a groundbreaking therapy in pre-clinical stage for sufferers of Type II diabetes. Renova Therapeutics was founded in 2009 and is led by an experienced management team that co-founded the first publicly traded cardiovascular gene therapy company, Collateral Therapeutics.

Photo – http://photos.prnewswire.com/prnh/20141117/159100
SOURCE Renova Therapeutics

The Dirty Side Of Soap, University of California, San Diego (UCSD) Study

November 18, 2014 – 5:00 am | Edit Post

The Dirty Side Of SoapTriclosan, a common antimicrobial in personal hygiene products, causes liver fibrosis and cancer in mice Triclosan is an antimicrobial commonly found in soaps, shampoos, toothpastes and many other household items. Despite its widespread use, researchers at University of California, San Diego School of Medicine report potentially…

Aurora Spine Receives FDA 510(k) Clearance For Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation Implant

November 18, 2014 – 5:00 am | Edit Post

Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation ImplantCARLSBAD, CALIFORNIA–(Marketwired – Nov 18, 2014) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51, Aurora Spine’s slimmest minimally invasive…

Renova Therapeutics Welcomes New Board Member, Raises $7.52 Million In Series C Financing Round

November 18, 2014 – 5:00 am | Edit Post

Renova Therapeutics welcomes new board member, raises $7.52 million in Series C financing roundSAN DIEGO, Nov. 18, 2014 /PRNewswire-USNewswire/ –Renova Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic…

Breaking Bottlenecks, Opening the Floodgates to Genomic Data

November 18, 2014 – 4:00 am | Edit Post

There is a major transformational step underway for managing the growing amount of human genomic data. To date, the focus has been on amassing databanks of genomes and then developing new tools to…

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Aurora Spine Receives FDA 510(k) Clearance For Pre-Packaged Sterile ZIP 51 MIS Interspinous Fixation Implant

November 17, 2014 – 5:00 pm | Edit Post

Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51(TM) MIS Interspinous Fixation ImplantCARLSBAD, CALIFORNIA–(Marketwired – Nov 18, 2014) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51, Aurora Spine’s slimmest minimally invasive…