|Pluristem and the Alliance for Regenerative Medicine (ARM) Meet Congress on April 29, 2014; Evoke Pharma Initiates Phase 3 Clinical Trial of EVK-001|
|By Staff and Wire Reports|
|Tuesday, 22 April 2014 20:00|
Pluristem Therapeutics, Inc. ($PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that Company executives are actively participating in a series of meetings in Washington D.C. regarding proposed legislation that may impact the future of cell therapy and regenerative medicine in the U.S.
"These initiatives are a very important effort by Pluristem, in collaboration with other industry thought leaders, to help bring about a legislative, funding, and reimbursement environment that can accelerate the commercialization of breakthrough cell therapies which have the potential to transform the lives of patients in need," stated Pluristem CEO, Zami Aberman.
Alliance for Regenerative Medicine (ARM) Legislative Fly-In on April 29, 2014 - Dr. William Prather, Senior Vice President Corporate Development, and Dr. Karine Kleinhaus, Divisional Vice President North America, will join fellow ARM members including patient advocacy organizations, research institutions and other regenerative medicine-focused companies at the organization's annual Legislative Fly-In. This event is dedicated to meeting with key members of Congress and Administration officials to describe the immense near-term potential of regenerative medicine and the need for legislation and policies that support the development of life saving therapies. ARM supports an important bipartisan bill, the Regenerative Medicine Promotion Act of 2014, which has been introduced in the Senate and calls for a U.S. national strategy to support regenerative medicine. Dr. Prather currently serves on ARM's Committee for Government Relations & Policy, Committee for Reimbursement, and the Sub-committee for Centers for Medicare & Medicaid Services Reimbursement. Dr. Kleinhaus serves on ARM's Committee for Capital Formation.
Michael Werner, Executive Director of ARM, stated, "Regenerative medicine represents the single most promising new approach to mitigating the human and economic costs of disease, and changing the course of human health. Pluristem, which pioneered promising cell therapies for a number of indications, has played a vital role in advocating for regenerative medicine within the biotech community and we are pleased that they are actively involved with ARM to move the entire industry forward. To date, ARM has worked with the White House, the U.S. Food & Drug Administration, and National Institutes of Health, National Institute of Standards & Technology and members of Congress to further define and promote adoption of a national strategy for regenerative medicine."
U.S. Food and Drug Administration Meeting on March 31, 2014 - Dr. Ohad Karnieli, Pluristem's Vice President of Development and Manufacturing met with representatives of the U.S. Food and Drug Administration at a public workshop titled, "Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products." Participants in this meeting included key opinion leaders from industry as well as organizations advocating for standards and guidelines that can advance regenerative medicine, including Pluristem. Advocacy Organizations participating in the meeting included Alliance for Regenerative Medicine (ARM), International Society for Cellular Therapy (ISCT), American Association of Blood Banks (AABB), National Institute of Standards and Technologies (NIST), and The United States Pharmacopeial Convention (USP). Dr. Karnieli currently serves on ARM's Science and Technology Committee and is Chair of the ISCT's Process and Product Development Committee.
Evoke Pharma, Inc. (Nasdaq: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the initiation of its Phase 3 clinical trial investigating the use of EVK-001, a novel metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.
We are very pleased to have our Phase 3 clinical trial for EVK-001 underway with the enrollment of our first patient into the study," said David Gonyer, R.Ph., President and Chief Executive Officer of Evoke Pharma. "Our goal is to address an important unmet need in treating gastroparesis: a therapy that can improve the GI symptoms, including nausea and vomiting, that are characteristic of this disorder. Building on our successful Phase 2 placebo-controlled study, this Phase 3 study is designed to confirm the results that showed EVK-001 is an effective and well-tolerated drug candidate for women with diabetic gastroparesis." "Gastroparesis in patients with diabetes can be very difficult to treat.
There are limited FDA-approved options and the absorption of oral medications can be unpredictable," said lead investigator Dr. Henry P. Parkman, Director of the GI Motility Laboratory at the Temple University School of Medicine. "EVK-001 has shown promising safety and efficacy results in previous diabetic gastroparesis studies and may provide a valuable treatment alternative for this patient population. Unlike oral medications, intranasal delivery bypasses the GI tract and directly enters the bloodstream, allowing predictable absorption regardless of the gastric emptying delays and symptom flares associated with the disease."
Gastroparesis is a disorder in which the stomach is delayed in emptying its contents to the small intestine (in the absence of an obstruction). Characteristic symptoms are nausea, vomiting, abdominal pain, early satiety and bloating. Gastroparesis interferes with absorption of food and medications in the GI tract due to unpredictable gastric emptying and vomiting. Symptom flares vary in severity and diminish quality of life, negatively impact blood glucose control, and may lead to complications requiring hospitalization.
The potential gastroparesis patient pool in the United States is approximately 12 to 16 million adults, with women making up over 80% of the affected population. The Phase 3 clinical trial is a four-week, multicenter, placebo-controlled, double-blind, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult female subjects with diabetic gastroparesis and is expected to enroll 200 patients at sites across the United States.
The trial is expected to be completed in 2015. About Evoke Pharma, Inc. Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women with diabetes mellitus.
Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced its 2013 Medicare Meaningful Use Stage 1 attestation rate among providers who use athenaClinicals®, athenahealth's award-winning EHR.
AtheroNova Inc. (OTCBB:AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that the reverse stock split approved by the Company's stockholders at last week's annual stockholder's meeting became effective as of the opening of trading on Tuesday, April 22, 2014.
Biodel Inc. (Nasdaq:BIOD) today announced the signing of a research supply and technology development agreement with the HEC Pharm subsidiary Yichang Chang Jiang Pharmaceutical Co., Ltd for ultra-rapid-acting insulin aspart. Under the agreement, HEC will supply insulin aspart, the active pharmaceutical ingredient (API) in Novolog®, which Biodel will use to formulate aspart based ultra-rapid-acting insulin formulations.
Caribbean International Holdings (Pink Sheets:CIHN) through its subsidiary, Regenerative BioScience, will add brain injuries including Chronic traumatic encephalopathy (CTE) as an additional area of focus to see how stem cells may help to improve the lives of those dealing with these difficult injuries.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today announced it will report financial results for the first quarter of 2014 on Thursday, May 1st, 2014 prior to the market's opening.
Cempra, Inc. (Nasdaq:CEMP) today announced that it will report first quarter 2014 financial results and provide a business update after the close of U.S. financial markets on April 29, 2014.
Cytomedix, Inc. (OTCQX:CMXI), a leading developer of biologically active regenerative therapies, today announced two key oral presentations and a poster presentation highlighting AutoloGel® will be made at the Symposium on Advanced Wound Care (SAWC) Spring Meeting, being held April 23-27, 2014, at the Gaylord Palms Hotel & Convention Center, in Orlando Florida. Cytomedix will also have an exhibition booth at the meeting (#901).
Elite Pharmaceuticals, Inc. (OTCBB:ELTP) announced today the issuance of U.S. Patent No. 8,703,186 titled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof".
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the initiation of its Phase 3 clinical trial investigating the use of EVK-001, a novel metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.
Intuitive Surgical, Inc. (Nasdaq:ISRG), the industry leader in surgical robotics, reported revenue consistent with its April 8, 2014, press release of $465 million for the first quarter of 2014, a decrease of approximately 24%, compared with $611 million for the first quarter of 2013.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that clinical and preclinical data for its lead drug candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held from May 30 to June 3, 2014 in Chicago, Illinois.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, today announced that the Company received its fiber testing equipment, including customized components, to test its latest genetically engineered prototype fiber, Big Red™.
Medical Marijuana Inc. (OTC Pink:MJNA) is pleased to announce that its subsidiary, Wellness Managed Services' new company, MPS International (MPSI) has been awarded a large annual physical security contract with the Denver Mart.
MRI Interventions, Inc. (OTCQB:MRIC) today announced it is proud to serve as a platinum sponsor of the 2014 Parkinson's Unity Walk in New York City's Central Park on Saturday, April 26.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it will issue financial results for the third fiscal quarter of 2014 following the close of market on Tuesday, May 6, 2014.
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries, today announced the commercialization in Mexico of the first product under the Microdacyn60® Oral Care brand intended for use as an adjunct treatment in both mouth and throat infections.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report first quarter 2014 results on Tuesday May 6, 2014.
Stericycle, Inc. (Nasdaq:SRCL) today announced that it has acquired PSC Environmental Services, LLC ("PSC Environmental"), a portfolio company of Lindsay Goldberg LLC and a leading provider of environmental and regulated waste management solutions.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that updated data from the ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored study of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) will be presented at the 2014 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, Illinois.
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime™ Abdominal Stent Graft System, today announced the closing of its initial public offering of 7,475,000 shares of its common stock at a public offering price of $12.00 per share, including 975,000 shares sold pursuant to the underwriter's option to purchase additional shares.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has entered into a cooperative research & development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) to develop a freeze-dried plasma product for use in battlefield treatment of severe hemorrhage.
Wally World Media, Inc. (OTCQB:WLYW) announced today that through its subsidiary, Vape Shop Holdings, it has signed a joint venture agreement with Vapir, Inc., a leading manufacturer and distributor of electronic vaporizers.