VBL Therapeutics Reports Interim Topline Results From Phase 2 Clinical Trial of VB-111; Vical Expands Infectious Disease Portfolio With Novel Antifungal Print E-mail
By William Kent   
Wednesday, 25 March 2015 18:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 25, 2015.
VBL Therapeutics (NASDAQ: VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, announced top-line interim results from its ongoing Phase 2 study of VB-111 in patients with recurrent glioblastoma (rGBM), which demonstrated a statistically significant improvement in overall survival in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin(R)) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone upon disease progression (p=0.05). Study results will be presented in conjunction with the American Society of Cancer Oncology (ASCO) Annual Meeting, May 29th-June 2nd, 2015 in Chicago, Illinois.
"We are extremely pleased by these interim results and are particularly excited to see a statistically significant improvement in overall survival in this needy patient population. We believe VB-111's ability to curb disease progression in this devastating illness further reinforces its broad potential as a gene therapy for a range of solid tumor indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We continue to work to bring VB-111 forward as a potential new treatment option, and look forward to initiating a pivotal Phase 3 trial in recurrent glioblastoma later this year."
These interim Phase 2 data include 46 patients with rGBM. VB-111 monotherapy was discontinued upon progression in 22 patients who were then treated with bevacizumab alone. The remaining 24 patients, upon disease progression on VB-111 monotherapy, could elect to receive further treatment with VB-111 in combination with bevacizumab. 23 have received combined therapy; one patient is still stable on VB-111 monotherapy at 424 days. VB-111 in combination with bevacizumab demonstrated a statistically significant improvement in overall survival, with median overall survival of 414 days, compared to 235 days in patients on VB-111 followed by bevacizumab alone (p=0.05).
VBL's pivotal Phase 3 clinical trial will be led by Dr. Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and is expected to initiate in mid-2015 under a special protocol assessment granted by the FDA.
Study Details -- The Phase 1/2 trial is a multi-center, two stage, dose-escalation study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. In the first stage of the study, patients were treated with VB-111 alone. Upon disease progression -- defined according to the Response Assessment in Neuro-Oncology (RANO) criteria as a worsening of the patient's cancer with an increase of at least 25% in the overall mass of measurable tumors, the appearance of new tumors, the worsening of non-measurable tumors since the beginning of treatment, a need for increased dose of corticosteroids, or clinical deterioration -- patients entered the second stage in which they received either bevacizumab alone or bevacizumab in combination with VB-111, in two sequential cohorts.
 
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Vical Incorporated (Nasdaq:VICL) announced it has expanded its infectious disease portfolio with the addition of a novel antifungal, ASP2397, in-licensed from Astellas Pharma Inc. (TOKYO:4503) ("Astellas"). ASP2397 represents a potential new class of antifungal compounds to address invasive Aspergillus infections, which are major causes of morbidity and mortality in immunocompromised patients, including transplant recipients. ASP2397 is differentiated by a new mechanism of action and has a low propensity for P450 drug-drug interactions. In preclinical studies to date, it has demonstrated faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. As part of the agreement, Astellas, which is also Vical's partner for the ASP0113 CMV vaccine program in transplant recipients, will become a shareholder in Vical.
"It is exciting to see a novel antifungal with preclinical data showing potent and rapid fungicidal activity, and low potential for drug-drug interactions. Such a drug could become a treatment of choice for front-line therapy of invasive fungal infections," said John R. Perfect, M.D., Chief of Division of Infectious Diseases at Duke University Medical Center.
Under the terms and conditions of the license agreement, Astellas granted Vical an exclusive worldwide license to develop and commercialize ASP2397. Astellas will receive Vical common stock equivalent to approximately 1% of outstanding shares and $250 thousand in cash. Astellas will also be eligible for up to $100 million in aggregate milestone payments, the vast majority of which are commercial and sales milestones, and single-digit royalties on net sales. The above agreement does not impact Vical's cash burn guidance, which remains at between $12 million and $15 million for 2015.
"ASP2397 is an exciting opportunity that has arisen out of the relationship we have built with Astellas," said Vijay B. Samant, Vical's President and CEO. "While advancing our CMV and HSV-2 programs remains the top priority at Vical, this novel candidate adds depth to our pipeline and strengthens Vical's position as an infectious disease company."
"ASP2397 is a unique antifungal discovered at Astellas, and we are pleased to partner it with Vical, who we believe has the right capabilities to develop this compound and bring it to market," said Naoki Okamura, Corporate Vice President and Global Head of Business Development at Astellas.
ASP2397 is a novel natural product discovered by Astellas from leaf litter fungus collected in a Malaysian national park. In vitro and in vivo data were featured in two posters presented during the ICAAC 2014 meeting last September. Most of the IND-enabling preclinical studies have been completed by Astellas, and Vical is targeting initiation of a Phase 1 trial in the first half of 2016.
Vical consulted an expert team of advisors during the evaluation of ASP2397 and is forming a Clinical Advisory Board (CAB) to help direct the development program. Initial members of the CAB include:
  • John R. Perfect, M.D., Chief of Division of Infectious Diseases, Duke University Medical Center
  • Dennis Schmatz, Ph.D., consultant, 30-year veteran of Merck and team leader for Cancidas (caspofungin)
  • Michael R. Hodges, M.D., consultant, 17-year veteran of Pfizer and team leader for Vfend (voriconazole)
Vical intends to develop ASP2397 as a front-line therapy for invasive aspergillosis and as part of combination regimen for preemptive treatment of fungal infections, which may represent a meaningful commercial opportunity within the $4 billion global market for systemic antifungals. Current treatment options have limited efficacy, as approximately 50-60% of allogeneic hematopoietic stem cell transplant recipients with invasive aspergillosis infections die within 12 weeks. Over the past 30 years, only one new class of antifungal drugs (echinocandins) has been introduced.
Conference Call  --  Vical will conduct a conference call and webcast tomorrow, March 26, at 8:30 a.m. Eastern Time. Listeners may access the accompanying slide presentation through the webcast at www.vical.com. The call and webcast will be open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2308 (preferred), or (888) 312-3048 (toll-free), and reference confirmation code 2695093. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 2695093. The webcast portion of the call will be available live and archived through the events page at www.vical.com. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by e-mail at [email protected]
 
Also Wednesday:
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that the Chinese Patent Office has granted Acasti a composition and use patent (the "Patent").
Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the fourth quarter and year ended December 31, 2014.
BioCorRx, Inc. (BICX), developer of the Start Fresh Program, announces the execution of a definitive agreement with Myriad Medical Marketing (MMM).  The Company had previously announced the letter of intent to enter into an agreement with MMM back on February 27, 2015. 
BioTelemetry, Inc. (Nasdaq:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced today the completion of the Department of Justice investigation with the signing of a settlement agreement between the two parties. Per the agreement, BioTelemetry will pay $6.4 million to the Department of Justice, which was reflected in the Company's 2014 financial statements.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced that it will report its results for the fourth quarter and fiscal year ended December 31, 2014 on Tuesday, March 31, 2015. 
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced interim 24-week clinical data from the Phase IIb trial of its ReJoinTM human adipose-derived mesenchymal progenitor cell (haMPC) therapy for Knee Osteoarthritis (KOA). 
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced clinical data from its CAR-T immuno-oncology clinical development programs. 
Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today reported financial results for the quarter and year ended December 31, 2014 and provided an update on its clinical development programs and outlook for 2015.
Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. 
FutureWorld Corp (OTCQB: FWDG), FutureLand Properties, a specialty zoning land leasing company formed to capitalize on the emerging global cannabis market, provides an update on its progress in the State of Colorado.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the home care setting, announced today that its new manufacturing facility in Richardson, Texas is now operational supporting product manufacturing, packaging, and logistics. 
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that it is scheduled to make presentations regarding its ITI-007 schizophrenia program at the 15th International Congress on Schizophrenia Research (ICOSR) in Colorado Springs, March 28th - April 1st 2015.
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 NILE™ Alternative Fixation Spinal System, the Company's latest offering for addressing the most complex spinal deformity cases. 
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation for ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, for the treatment of protocadherin 19 gene (PCDH19) female epilepsy. 
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, and Scripps Health, a private, nonprofit, integrated health system in San Diego, California, today announced publication of a study that demonstrates the clinical and economic impact of implementing rapid sepsis diagnostic testing with the Company's FDA-cleared Verigene® Gram-Positive Blood Culture Test (BC-GP) in combination with Antimicrobial Stewardship Team (AST) intervention.
Nasdaq (Nasdaq:NDAQ) announced that trading of Cellectis SA (Nasdaq:CLLS) commenced on The Nasdaq Stock Market on March 25, 2015.
NUO Therapeutics (OTCQX:NUOT), a pioneer in biodynamic therapies, announced today that it will report financial results for the fourth quarter and full year 2014 on Tuesday, March 31, 2015, after the close of market.
Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced the appointment of Dr. Roger Dodd as Senior Scientific Advisor to the Company's development team for the MosaiQ™ donor disease screening consumable. 
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), announced today that it has completed its previously announced underwritten public offering of 7.5 million common shares at a price of US$20.25 per share for aggregate gross proceeds of US$151.9 million before deducting underwriting discounts and commissions and other offering expenses. 
Trillium Therapeutics Inc. (Nasdaq:TRIL) (TSX:TR), an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that Robert Uger, PhD, the Company's Chief Scientific Officer, will be presenting at the 5th Annual "Cancer Immunotherapy: A Long Awaited Reality" Conference at the New York Academy of Medicine in New York City on March 26, 2015. 
Trinity Biotech plc (Nasdaq:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced that it has filed its Form 20-F containing audited consolidated financial statements for the year ended December 31, 2014 with the U.S. Securities and Exchange Commission. 
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today reported its financial results and corporate update for the fourth quarter and full-year ended December 31, 2014.
Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported that positive results from the three-year extension of the Phase 3 SUMMIT study with MACI™ (matrix-applied characterized autologous cultured chondrocytes) were presented at the annual meeting of the American Association of Orthopedic Surgeons in Las Vegas.
Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications, today announced financial results for the year ended December 31, 2014.



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