|MediciNova Receives Notice of Allowance for New Patent Covering MN-221; FDA Grants TEVA Therapy Designation for SD-809|
|By Mary Davila|
|Tuesday, 10 November 2015 19:42|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 10, 2015.
MediciNova, Inc., (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the Japan Patent Office of MN-221 (bedoradrine) for the treatment of irritable bowel syndrome.
Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than April 2031. The allowed claims cover a compound, pharmaceutical composition and a method of treating irritable bowel syndrome. MediciNova intends to use bedoradrine in future development.
"We are very pleased that this new patent will be granted as we believe it could substantially increase the potential value of MN-221," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.
"This is an opportunity to allow us more flexibility to consider pursuing other indications for MN-221 in future development."
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to SD-809 (deutetrabenazine) for the treatment of patients with moderate to severe tardive dyskinesia, a hyperkinetic movement disorder affecting about 500,000 people in the United States.
Breakthrough Therapy Designation is granted to a drug that is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapy or placebo where there is no available therapy. For SD-809, the designation request included results from Teva's Phase II/III study, Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD). In the ARM-TD study, SD-809 was compared to placebo for change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to end of therapy.
"The granting of Breakthrough Therapy Designation by the FDA represents significant progress toward advancing the clinical program for SD-809, as a potential, much-needed treatment option for the underserved tardive dyskinesia patient population. We remain excited about studying this innovative compound across a number of indications," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva.
Tardive dyskinesia, for which there are no approved therapies in the United States, has been described as a condition characterized by repetitive and uncontrollable movements of the tongue, lips, face, and extremities and has been reported with some widely used medications for psychiatric conditions such as schizophrenia and bipolar disease, as well as with certain drugs used for treating various gastrointestinal disorders.
Affimed N.V. (Nasdaq:AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the quarter ended September 30, 2015.
"Over this past quarter, we have made progress on several fronts. In terms of pipeline, we are currently enrolling patients in the amended AFM11 study. We also presented data for the first time of our NK- and T-cell engaging TandAbs against a solid tumor target, variant III of the Epidermal Growth Factor Receptor," said Dr. Adi Hoess, CEO of Affimed. "In addition, the recent renewed commitment by a long-term existing shareholder was a validation of our proprietary NK- and T-cell engaging TandAb approach to fight cancer."
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today announced that Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, will present at the Stifel 2015 Healthcare Conference on November 17, 2015 at The New York Palace Hotel in New York, NY.
Event: Stifel 2015 Healthcare Conference
Date: Tuesday, November 17, 2015
Time: 3:45 p.m. ET
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce that it has submitted to the FDA the 24-month clinical data outcomes from its CASCADE study, a blinded, randomized clinical trial that compared outcomes of cervical fusion between Amedica’s composite silicon nitride devices manufactured with an integrated core of cancellous structured ceramic (CsC), to the existing standard, i.e., PEEK (polyether ether ketone plastic) spacers filled with bone autograft.
The CASCADE study enrolled patients in a prospective trial that independently scored fusion rates and clinical outcomes at 24 months. The study was designed to compare the effects of Amedica’s porous silicon nitride versus bone autograft – the patient’s own bone – on patient outcomes. The silicon nitride interbody device was wetted with blood from the surgery site, but had no extrinsic bone graft material added to it. The control group was a PEEK, plastic, cage filled with bone autograft harvested during the decompressive discectomy. Results showed comparable clinical and radiographic performance between porous silicon nitride and bone autograft through a number of validated scientific clinical outcome measures.
“Porous silicon nitride is the first synthetic material to demonstrate spinal fusion outcomes that are similar to the patient’s own bone,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “These outcomes are consistent with our investigations of the surface chemistry and nano-topography of silicon nitride. This 24-month data has been submitted to the FDA in support of our application seeking clearance to commercialize our composite cervical interbody fusion device. Achieving clearance for this product is very important to us, as it furthers our mission to improve patient health through the enhancement of clinical outcomes for those patients who utilize our products, which is why we invested the necessary time in data gathering and analysis to ensure that we had it right before FDA submission.”
Aptose Biosciences Inc. (Nasdaq:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced two collaborations that will provide exclusive access to new epigenetic therapeutics for the Company's oncology pipeline. These partnerships have been strategically formed to leverage Aptose's scientific and clinical expertise in cancer and hematologic diseases to develop mechanistically differentiated and high-value epigenetic drug candidates.
Strategic Collaboration with Moffitt Cancer Center --- Aptose has entered into a definitive agreement with Moffitt Cancer Center for exclusive global rights to potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers. These small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes. The molecules developed by Moffitt exhibit single-digit nanomolar potency against the BET family members and specific oncogenic kinases which, when inhibited, are synergistic with BET inhibition. Under the agreement, Aptose will gain access to the drug candidates developed by Moffitt and the underlying intellectual property covering the chemical modifications enabling potent bromodomain (BRD) inhibition on the chemical backbone of a kinase inhibitor. Aptose expects lead clinical candidates to emerge from the collaboration by late 2016.
Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, today announces that it has converted its previously filed provisional patent application for Phospholipid-Ether Analogs as Cancer Targeting Drug Vehicles to non-provisional US and International (PCT) patent applications.
These patent applications further protect PDCs developed with Cellectar's proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.
Both composition of matter and methods of use are covered by these patent applications and provide intellectual property protection in the United States and up to 148 additional countries. This protection extends through at least November, 2034 in the US and key international markets.
"This patent protects all PDCs comprised of cytotoxic compounds, including chemotherapeutics, and provides Cellectar and potential partners with 20 years of product development and commercialization runway in key markets," said Jim Caruso, president and CEO of Cellectar. "This expanded protection supports the value-optimizing potential of our CLR CTX chemotherapeutic program and we look forward to sharing future advancements."
CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today reported financial and operating results for the third quarter ended September 30, 2015.
Corporate Highlights --- CoLucid continues to enroll patients in SAMURAI, its first of two pivotal Phase 3 clinical trials. The objective of SAMURAI is to evaluate the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo two hours after dosing. The primary endpoint is freedom from migraine headache pain and the key secondary endpoint is freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia). The company maintains its guidance to have SAMURAI fully enrolled by the end of the second quarter of 2016, with top-line data available in the third quarter of 2016.
CoLucid initiated GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR's objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. The first patient was randomized in October and by the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.
"CoLucid continues to execute on aggressively enrolling our SAMURAI study with the goal of generating top-line data in the third quarter of 2016, as well as randomizing patients who complete SAMURAI into GLADIATOR for long-term, open-label utilization of lasmiditan," said Thomas P. Mathers, Chief Executive Officer. "A large proportion of migraine patients who have been enrolled in SAMURAI to date have multiple risk factors for cardiovascular disease or some forms of stable cardiovascular disease. Lasmiditan's non-vasoconstrictive mechanism of action may be appropriate for the acute treatment of migraine patients with cardiovascular risk as they may be contraindicated or warned against utilizing currently marketed acute treatments. We continue to believe that these underserved migraine patients may benefit by the acute treatment of their migraine attacks with lasmiditan."
The company maintains its current guidance to have cash on hand to fund its two pivotal clinical trials of lasmiditan and operations through mid-2017.
CymaBay Therapeutics, Inc. (Nasdaq:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, today announced the initiation of a Phase 2 study of MBX-8025 in patients with primary biliary cholangitis. MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist.
Primary biliary cholangitis (PBC), formerly referred to as primary biliary cirrhosis, is an orphan autoimmune disease affecting primarily women over the age of 40. Patients with PBC often experience fatigue and pruritus. The disease is characterized by inflammation and the immune-mediated destruction of the small intrahepatic bile ducts resulting in the reduction or stoppage of bile flow, a condition referred to as cholestasis. The accompanying build-up of bile acids leads to chronic liver inflammation and fibrosis that may progress to cirrhosis and hepatic failure. The only approved drug for PBC is ursodiol. However, approximately 40% of patients do not respond to ursodiol adequately and would benefit from a newer therapy.
"I am pleased to report that we initiated a placebo-controlled, dose-ranging Phase 2 study for MBX-8025 in patients with PBC," said Harold Van Wart, Ph.D., President and Chief Executive Officer of CymaBay. In this study, patients who have had an inadequate response to ursodiol will be enrolled and randomized to receive either placebo or MBX-8025 (either 50 mg or 200 mg) for 12 weeks. The primary endpoint will be the change in alkaline phosphatase, a parameter that has been used in prior clinical studies with PBC and which is believed to reflect the status of the disease. A variety of secondary outcomes will also be studied. The study is designed to enroll approximately 75 patients in the U.S., U.K., Canada, Germany and Poland and is expected to be completed around the end of 2016.
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 ended September 30, 2015 and provided an update on its clinical development programs.
"Our clinical development programs continue to move forward, and I am pleased to report another quarter of solid progress for Dermira. The initiation of our Phase 3 program for DRM04 in hyperhidrosis, the successful closing of our follow-on offering and the completion of patient enrollment for our CIMPASI-2 Phase 3 study with CIMZIA in moderate-to-severe plaque psoriasis are all major milestones for our company," said Tom Wiggans, chairman and chief executive officer of Dermira. "I believe we will end 2015 well positioned for a series of potentially value-enhancing events in 2016 and 2017. Specifically, we expect to announce topline results from all three of our active development programs, including the DRM01 Phase 2b study in acne in the first half of 2016, the DRM04 Phase 3 program in hyperhidrosis in the second half of 2016, and the CIMZIA Phase 3 program in psoriasis in 2017."
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced the acquisition of a Focal One system by Clinica Santa Maria, Santiago de Chile, one of the country's largest groups of private urology clinics.
Dr. Alfredo Velasco P., Head of the Urology Department and robotic surgeon at Clinica Santa Maria, commented: "Addressing prostate cancer is a major challenge for Urologists today. We clearly see positive advances in technologies such as Focal One that allow for less invasive treatments with minimal side effects for patients. Innovations in imaging technologies have led to the emergence of the focal approach in the treatment of localized prostate cancer. With the early detection of prostate cancers and ability to identify smaller cancerous areas, traditional robotic surgery, radiotherapy and brachytherapy are no longer suitable to address these little, early-stage, tumor cells. This is why, to remain at the forefront in the treatment of prostate cancer, Clinica Santa Maria decided to add Focal One HIFU to its existing state-of-the-art therapeutic arsenal in urology."
Marc Oczachowski, EDAP's Chief Executive Officer, added: "We are very pleased with the sale of our first Focal One HIFU device in Latin America. EDAP is well established in this region of the world via a large installed base of Lithotripters and Ablatherm Robotic HIFU systems. A great number of Latin American patients have already benefited from Ablatherm HIFU, and the introduction of Focal One at one of the region's largest urology groups will increase the range of therapeutic options and allow patients access to the cutting edge focal approach to prostate cancer management."
Enzymotec Ltd. (NASDAQ:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid-based nutritional ingredients and medical foods, today announced that the Company will host a VAYA Pharma Analyst and Investor Day at Four Times Square in New York City on November 19, 2015, beginning at 12pm ET.
The meeting will feature presentations from VAYA Pharma's Chief Executive Officer, Rob Crim, and its executive team on VAYA Pharma's growth strategies, research and development and marketing programs.
Enzymotec will host a live webcast of the event at www.enzymotec.com. The webcast and related presentation materials will also be archived on the website. Prior registration is required with The Ruth Group.
Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that Dave Gonyer, R.Ph., President and CEO will be participating in the Brean Capital 2015 Life Sciences Summit on Monday, November 16, 2015 at the Millennium Broadway Hotel in New York City.
A copy of the corporate presentation will be posted to the company's website prior to the conference.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, announced that preliminary data from part 3 of Five Prime's ongoing Phase 1 trial of FPA008 in rheumatoid arthritis (RA) patients were presented today at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals Annual Meeting in San Francisco. FPA008 is Five Prime's anti-CSF1R antibody that blocks the binding of CSF1 and IL-34 ligands to CSF1R, resulting in inhibition of the activation and survival of inflammatory macrophages and osteoclasts.
The Phase 1 clinical trial of FPA008 is being conducted in three parts. Parts 1 and 2 involved dose administration and escalation in healthy volunteers and data on safety, pharmacokinetics (PK), and biomarkers from this portion of the study were presented during the 2014 ACR Annual Meeting. Part 3 of the trial consists of an open-label evaluation of 2 or 3 doses of FPA008 at 3 dose levels in RA patients on a stable dose of methotrexate who have not responded adequately to disease modifying anti-rheumatic drugs. The primary endpoint of the trial is safety, with secondary endpoints including PK, pharmacodynamics (PD) and disease activity as measured by ACR scores and joint MRI.
GeneOne Life Science Inc. (KSE:011000) today announced that it has signed a cooperative research and development agreement with the Walter Reed Army Institute of Research (WRAIR) to advance GLS-5300, GeneOne’s DNA vaccine for MERS (Middle East Respiratory Syndrome). GeneOne is co-developing GLS-5300 with its affiliate Inovio Pharmaceuticals (NASDAQ:INO).
As part of this agreement, GeneOne and WRAIR will test the GLS-5300 vaccine in a first-in-human phase I clinical study to be executed at the WRAIR’s Clinical Trials Center. WRAIR will be responsible for all relevant MERS vaccine clinical trial procedures and costs at the Walter Reed Army Institute of Research.
Middle East Respiratory Syndrome is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS) virus that infected more than 8,000 people over 10 years ago, with a 10% death rate. There is no vaccine or licensed therapeutic against MERS, which spreads from human to human. Since 2012, over 1,650 people have had documented MERS infections and almost 600 (40%) have died. Recently, the largest outbreak of this emergent global health concern outside of Saudi Arabia infected 186 people in South Korea with 36 fatalities.
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer, distributor, and virtual administrator of affordable health plans today announced that CEO Patrick McNamee will present at the 24th Annual Credit Suisse Healthcare Conference tomorrow November 11, 2015, at The Phoenician in Scottsdale, AZ. The presentation will begin at 11:30 AM MT (1:30 PM EST). Interested investors and other parties may listen to a simultaneous webcast of the presentation by logging on to the Investor Relations section of the company's website at HiiQuote.com. The presentation slides will be posted on HII's website prior to the event.
Inogen, Inc. (NASDAQ:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today reported financial results for the three months ended September 30, 2015.
Third Quarter 2015 Highlights
"Results in the third quarter of 2015 once again included revenue growth across all of our channels. Direct-to-consumer sales revenue represented 63.7% growth over the same period in the prior year, highlighting the strength of our model," said President and Chief Executive Officer, Raymond Huggenberger. "I am delighted with the number of qualified sales candidates we were able to bring on board in the quarter, meaningfully expanding our capacity for the future, while at the same time, continuing to provide a strong profit in the current period. We also continued to invest in product innovation, which we expect will enable us to maintain our leadership position in the portable oxygen concentrator market. I believe these strategic investments position us well as we look towards continued growth opportunities in 2016."
Invuity, Inc. (NASDAQ:IVTY), an advanced medical technology company, today reported financial results for the third quarter and nine-months ended September 30, 2015.
Q3 2015 Highlights
Since inception, approximately 125,000 procedures have been performed using Invuity devices, up from 66,000 procedures performed through the third quarter of 2014.
"We were very pleased with our execution during the third quarter including our Q3 financial results. We are expanding our commercial platform, increasing the body of clinical and economic data that supports our product offering, and rapidly introducing new products to our product portfolio," said President and CEO Philip Sawyer. "Furthermore, the recent introduction of our Hidden ScarTM program for Breast Cancer Surgery represents the first of several innovative offerings targeting the overall customer chain in today's medical marketplace. We are delighted by the early success. All of these initiatives will provide us with a strong foundation for future growth."
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced today that it has commenced an underwritten public offering of up to 2,000,000 shares of its common stock. Loxo Oncology also expects to grant the underwriters a 30-day option to purchase up to an additional 300,000 shares of its common stock offered in the public offering solely to cover overallotments, if any, at the public offering price less the underwriting discounts and commissions. All of the shares will be offered and sold by Loxo Oncology.
Citigroup Global Markets Inc. and Cowen and Company, LLC are acting as joint book-running managers for the offering. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Loxo Oncology intends to use the net proceeds from this offering for general corporate purposes, which may include funding research and development, increasing its working capital, acquisitions or investments in businesses, products or technologies that are complementary to its own and capital expenditures.
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective therapeutics for the treatment of serious and life-threatening infections, today announced its financial results for the quarter ended September 30, 2015.
The Company also reviewed the progress of its lead drug candidate MAT2203, an orally-administered, encochleated formulation of the broad spectrum fungicidal medication amphotericin B, and the development plans for MAT2501, an orally administered, encochleated formulation of the broad spectrum aminoglycoside antibiotic amikacin to treat gram-negative bacterial infections and other intracellular bacterial infections.
“2015 has been a truly transformational year for Matinas BioPharma. We believe that our entry into the anti-infective space sets the stage for the company to unlock the unlimited potential of our disruptive, proprietary, lipid-crystal nano-encapsulation platform technology,” commented Roelof Rongen, President and Chief Executive Officer. “We have made substantial progress on the corporate and operational fronts by aligning the company with preeminent clinical and scientific advisors, appointing key executives, and advancing our clinical development and regulatory strategies for a milestone-driven year ahead.”
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will present at three investor conferences in the next few weeks.
On Monday, November 16, Merit’s Chairman and Chief Executive Officer Fred P. Lampropoulos and Chief Financial Officer Bernard Birkett will participate in one-on-one meetings at the Barclays MedTech SMID Cap Day Conference in Barclays’ New York City office.
On Thursday, November 19, at 4:30 p.m. ET, Lampropoulos will present at Canaccord Genuity’s Medical Technologies & Diagnostics Forum at the Westin Grand Central in New York City. He and Birkett will participate in one-on-one meetings throughout the day.
On Tuesday, December 1, at 12:00 noon ET, Lampropoulos will participate in a panel discussion entitled “Insights from MedTech Founder CEOs” at the 27th Annual Piper Jaffray Healthcare Conference at The Lotte New York Palace. He and Birkett will also participate in one-on-one meetings throughout the day.
Metabolix, Inc. (NASDAQ:MBLX), an advanced biomaterials company focused on sustainable solutions for the plastics industry, today reported financial results for the three months ended September 30, 2015.
“Throughout 2015, we have been executing a strategic transformation of the Company with a focus on our Mirel® specialty biopolymers business,” said Joseph Shaulson, president and CEO of Metabolix. “This specifically included a goal to expand our pilot capacity and achieve increased visibility and progress in commercial development, allowing us to complete our pivot to the specialties business model and sharpen our focus on moving to commercial scale. For the coming quarters, we are ramping up pilot production to run at nameplate capacity for 2016 and expect to sell a significant portion of the amorphous PHA (a-PHA) material we produce to customers for use in commercial applications. We also plan to use a stream of pilot a-PHA material to continue commercial development work with both existing and prospective customers for our specialty biopolymers. With increasing clarity on customer conversions and confidence in market development, we are accelerating our efforts to secure our first tranche of commercial scale capacity.
“During the quarter, we completed more than 15 customer trials across our target application spaces of PVC processing aids and property modifiers, PLA modification, functional biodegradation and paper coating. Based on this progress, we expect to see additional customer conversions in the fourth quarter of 2015 and early 2016.
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 Barclay “Buck” Phillips, SVP, Chief Financial Officer and Treasurer, will present at the Stifel 2015 Healthcare Conference.
Conference details are as follows:
Date: Tuesday, November 17, 2015
Time: 4:30 p.m. US Eastern Time
Location: New York Palace Hotel, New York City
Live webcast: http://www.veracast.com/webcasts/stifel/healthcare2015/86112760876.cfm
The webcast and a replay of the presentation will also be accessible under the “Investors/Events” section of the Novavax website at novavax.com.
Oryzon Genomics, a clinical stage biopharmaceutical company leveraging epigenetics to develop therapies in oncology and neurodegenerative diseases, announced today the dosing of the first patient in the extension cohort (Part 2) of its ORY-1001 Phase I clinical trial.
Roche and Oryzon entered into a worldwide collaboration in April 2014 to research, develop and commercialize inhibitors of Lysine Specific Demethylase-1 (LSD1; KDM1A), an epigenetic modulator that regulates gene expression, including Oryzon's lead clinical candidate ORY-1001. Based on the multiple ascending dose (MAD) stage (Part 1) of Oryzon's Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of ORY-1001 in patients with relapsed or refractory acute leukemia (AL), a recommended dose (RD) of ORY-1001 has been established. The preliminary results obtained during the MAD stage of the trial demonstrate the safety and tolerability of ORY-1001 in patients suffering from AL.
The objective of this extended cohort of the Phase I clinical trial is to evaluate the preliminary efficacy of ORY-1001. This extension cohort is performed to explore the ORY-1001 treatment efficacy at the recommended dose in various genetically selected subpopulations of patients suffering from acute myeloid leukemia (AML). This includes mixed lineage leukemia (MLL), a rare subset of AL in which leukemia stem cells are specially sensitive to LSD1 inhibition. To recruit a sufficient number of patients suffering from this rare form of leukemia, Oryzon has increased the number of active centers to 10. For a complete list of active centers visit www.oryzon.com.
Otonomy, Inc. (NASDAQ:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today reported financial results for the quarter ended September 30, 2015 and provided an update on its corporate activities and product pipeline.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today reported financial results for the quarter ended September 30, 2015.
For the third quarter of 2015, OXiGENE reported a net loss of $3.6 million compared to a net loss of $3.5 million for the comparable period in 2014. R&D expenses during the third quarter of 2015 were $2.5 million compared to $2.2 million in the third quarter of 2014. General and administrative expenses during the third quarter of 2015 were $1.1 million compared to $1.2 million in the third quarter of 2014.
At September 30, 2015, OXiGENE had cash of $30.3 million, compared to $30.0 million at December 31, 2014.
"We have recently announced encouraging preliminary data for CA4P in both neuroendocrine tumors and recurrent ovarian cancer and have commenced an expanded phase 1b/2 clinical trial of OXi4503 in acute myeloid leukemia," said William D. Schwieterman, M.D., OXiGENE's President and Chief Executive Officer. "Simultaneously, we are moving forward with the advancement of CA4P in our planned phase 2/3 trials in platinum resistant ovarian cancer and glioblastoma multiforme. I continue to be encouraged by the data supporting the efficacy of our vascular disrupting agents, and I believe the opportunities we have to advance the treatment of cancer are substantial."
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®, announced today that Manuel Hidalgo, MD, PhD, an internationally respected oncologist and a member of PharmaCyte ’s Scientific Advisory Board, has been named Clinical Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center, part of the Cancer Center at the Beth Israel Deaconess Medical Center (BIDMC) in Boston. Dr. Hidalgo has also been appointed Chief of the hospital’s Division of Hematology-Oncology. In his role at the prestigious medical center, Dr. Hidalgo will oversee all of BIDMC’s clinical cancer programs.
Dr. Hidalgo, whose groundbreaking work in experimental cancer therapy and tumor model development has led to key advances in the treatment of pancreatic cancer, will join the BIDMC this month. He is currently serving as the Director of the Clinical Research Program and Vice Director of Translational Research at the Spanish National Cancer Center. Dr. Hidalgo also holds faculty positions at University CEU San Pablo and Johns Hopkins University.
Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte Biotech, commented “We would like to offer Dr. Hidalgo our sincerest congratulations on his appointment at such a well-recognized center of excellence as the BIDMC. We are sure that his expertise in treating pancreatic and other solid tumors will be a great addition to the talent already at the Cancer Center of the BIDMC and, most importantly, will help ensure that patients treated at the Cancer Center receive the best and most up-to-date treatments possible for their disease.”
PositiveID Corporation (OTCQB:PSID), a life sciences company with an extensive patent portfolio, announced today that it has completed a new sample preparation breadboard system which complements, and works in conjunction with the Company’s Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”).
The new Firefly Dx prototype system incorporates sample preparation on a disposable injection molded cartridge that removes contaminants and purifies samples for processing and detection with PCR. Including sample preparation on the prototype system is expected to improve the ability to purify the sample and detect the organism of interest at much lower levels.
Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets' report Polymerase Chain Reaction (PCR) - Products/Tools - A Global Market Watch, 2009-2015.
“In addition to having PCR capabilities on the Firefly Dx prototype, we are now at the next iteration of the design, which includes sample prep,” said William J. Caragol, Chairman and CEO of PositiveID. “In a short period of time, we expect to be at a stage of our development where we can take a sample (whole organism), run it through sample prep and purification followed by the real-time optics and PCR testing on one system. That will be a critical milestone in our development as we prepare for field-testing later next year.”
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced that the company's Chief Financial Officer, Stephen Unger, will present at the Canaccord Genuity Medical Technology & Diagnostics Forum in New York City at 2:30 p.m. Eastern Time on Thursday, November 19. The presentation will be webcast live on the company's website at www.quotientbd.com.
Rocky Mountain High Brands, Inc. (OTCPK:RMHB) announced today that they have received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on their new Blue Leaf design. Upon completion of the process showing that the mark is in service, a trademark will be issued.
When the United States Patent and Trademark Office (USPTO) intends to issue a trademark, it sends the applicant a Notice of Allowance. For this to happen, an applicant provides information such as product description, design, and blueprints or drawings. A patent examiner then processes the patent application, and ultimately decides whether a patent should be issued. For the patent to be issued, the applicant must complete two additional steps after receiving the notice -- pay the required issue fee and submit any final drawings. In the United States, a Trademark is a form of legal protection granted to the assignee.
Currently, Rocky Mountain High Brands is marketing and selling a line-up of beverages in the marketplace that contain 100 mg of hempseed extract in each 12 oz. can. Seeds of the plant cannabis sativa – also known as hemp seed, contain all the essential amino acids and essential fatty acids necessary to maintain healthy human life. No other single plant source has the essential acids in such an easily digestible form, nor has the essential fatty acids in as perfect a ratio to meet the nutritional needs of human beings. Thus, hemp seed and hemp seed oil may be considered to be the most nutritionally complete food source in the world.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), which is developing next-generation medicines for fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache, today presents additional results from its completed 12-week, 205-patient Phase 2b BESTFIT clinical study of Tonmya (TNX-102 SL; cyclobenzaprine HCl sublingual tablets, 2.8 mg) for the treatment of fibromyalgia. Tonmya is designed for chronic daily use at bedtime to treat fibromyalgia.
Tonmya is currently being evaluated in the 500-patient Phase 3 AFFIRM study in fibromyalgia. As accepted by the U.S. Food and Drug Administration, the primary outcome measure for this Phase 3 study is a pain responder analysis, defined as the proportion of patients who report at least a 30% reduction in pain from baseline at the end of the 12-week treatment period. Tonix expects to report top-line data from the AFFIRM trial in the third quarter of 2016.
"Our new analyses of the BESTFIT data show that those patients who reported the greatest improvement in sleep quality were the most likely to experience pain relief," said Seth Lederman, M.D., Tonix's chairman and CEO. "We also observed that the group treated with Tonmya was approximately twice as likely as placebo-treated patients to be in the top third of reported sleep quality improvement. Among all patients in BESTFIT who ranked highest in reported sleep quality improvement, twice as many Tonmya-treated patients experienced at least a 30% improvement in their pain as compared to those treated with placebo."
Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced that Jeffrey Hatfield, President and Chief Executive Officer, will present a company overview at the Stifel 2015 Healthcare Conference on Tuesday, November 17, 2015 at 11:00 a.m. EST at The New York Palace Hotel.
A live audio webcast of the presentation will be available via the "Investor Relations" page of the Vitae website, www.vitaepharma.com. A replay of the webcast will be archived on Vitae's website for 90 days following the presentation.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced third quarter 2015 financial results and provided an update on the Company’s clinical development programs, including the pivotal Phase 3 ZAF-311 bestPWS clinical trial of beloranib in Prader-Willi syndrome (PWS) and the Phase 2b ZAF-203 clinical trial of beloranib in severe obesity complicated by type 2 diabetes.
Clinical Update --- In October, Zafgen announced that the U.S. Food and Drug Administration (FDA) had placed its beloranib program on partial clinical hold and that the Company had elected to close the randomized portion of its pivotal Phase 3 ZAF-311 bestPWS clinical trial and proceed with the efficacy and safety data analysis. The Company also elected to close its Phase 2b ZAF-203 clinical trial and proceed to data analysis. The Company continues to expect that it will report top-line data from both clinical trials in the first quarter of 2016.
As previously reported, with newly implemented safety screening measures for thromboembolic disease, Zafgen is continuing its six-month open label extension (OLE) of the pivotal Phase 3 ZAF-311 bestPWS clinical trial in PWS to obtain important ongoing efficacy and safety data. The Company continues to offer an open-ended, unblinded extension study after patients have completed six months of OLE.
“We are focused on advancing our understanding of the potential efficacy and safety of beloranib in complex metabolic disorders, including PWS, and remain committed to the continued development of this promising program,” said Dr. Thomas Hughes, Chief Executive Officer of Zafgen. “The results from the pivotal Phase 3 ZAF-311 bestPWS and Phase 2b ZAF-203 clinical trials, together with the insights we are gaining from our thromboembolic disease screening and monitoring measures, will be critical in determining the potential benefit-risk profile for beloranib and next steps for the program, including the design of our second Phase 3 clinical trial for beloranib in PWS, ZAF-312.”