Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that Israel’s Ministry of Health has granted the Company approval to initiate an exploratory clinical study of its oral insulin capsule ORMD-0801 in patients with nonalcoholic steatohepatitis (NASH). The proposed three-month treatment study will assess the effectiveness of ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. Oramed plans on initiating the study in the coming month. “Data from our directed preclinical NASH studies and clinical studies of ORMD-0801 in diabetics has revealed, through exploratory endpoints, that our oral insulin capsule has the ability to reduce inflammation of the liver. Incidence of NASH is rapidly increasing, similar to the rates of increase in diabetes. We look forward to exploring ORMD-0801 as a potential treatment for NASH,” stated Oramed CEO, Nadav Kidron. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
Pluristem has announced its pivotal Phase III clinical trial to treat critical limb ischemia received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the coming months.
Pluristem’s PLX-PAD cells will be evaluated in a double blind, randomized, placebo controlled trial in 250 patients.
The global market for treating critical limb ischemia is $12 billion globally. 1.7 million patients who live in world’s largest and most advanced pharmaceutical markets suffer from this limb-threatening and life-threatening disease. This number is expected to top 2 million in the next five years.
Pluristem’s critical limb ischemia program has been selected by the European Medicines Agency for its Adaptive Pathways pilot project. This allows for faster marketing approval in Europe after a single pivotal Phase III trial.
In the current Phase III trial, an interim analysis of data will be made for the first 125 patients, potentially leading to early marketing approval in Europe. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S.
Regenerative medicines like PLX cells will have tremendous benefits on healthcare economics based on their efficacy and their non-invasive nature.
Can-Fite has reported that it is commencing patient recruitment in its global, pivotal Phase III trial of its lead drug candidate Piclidenoson in the treatment of rheumatoid arthritis. The study, titled ACRobat, will enroll 500 patients in Europe, Israel and Canada.
The company reported drug supplies for trial have been manufactured and are ready for administration. The trial will have an estimated cost of $5 million, a modest cost when considering the global market for rheumatoid arthritis drugs is currently $38.5 billion.
Can-Fite’s drug is being developed as a first line therapy and replacement for the current standard of care, Methotrexate. Methotrexate is the most widely used drug for rheumatoid arthritis.
90% of rheumatoid arthritis patients receive Methotrexate at some point in their disease, but 40-50% of patients stop taking it after five years, due to its serious side-effects.
Over 1,000 patients have been safely treated with Piclidenoson, which has shown no series side effects and has proven to be safe. Piclidenoson can offer a superior alternative to Methotrexate for patients who need a safe and effective drug that can be taken long term.
TEL AVIV, Israel, December 7, 2016 /PRNewswire/ —
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration’s (FDA) standards for establishing six months stability.
The study, conducted by Kitov’s manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three in each dosage forms (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg) met the criteria demonstrating stability for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application (NDA) submission which is planned during Q1 2017. The Certificate of Analysis demonstrated adequate stability required for submission, in accordance with FDA guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend the labeled shelf life.
“We are very pleased with the stability study results, which we believe complete the testing required for our New Drug Application to the FDA for KIT-302,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.
KIT-302 is a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5, 5 or 10 mg of amlodipine, indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration during Q1 2017.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial and its New Drug Application with the U.S. Food and Drug Administration is currently being prepared for submission. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
HAIFA, Israel, Nov. 01, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem’s application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem’s CLI program was previously selected by the European Medicines Agency (EMA) for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.
The multinational Phase III trial will be conducted in the U.S. as well as Europe. The U.S. Food and Drug Administration (FDA) has previously given positive feedback on the trial protocol in a pre-Phase III interaction. Pluristem’s intention is to file a request for marketing authorization in the U.S. and in Europe following a successful completion of this 250-patient trial.
“Pluristem is very pleased to receive clearance to commence our pivotal Phase III CLI trial in the United Kingdom. We are eager to move forward to confirm efficacy of PLX-PAD cells in CLI, and anticipate receiving similar authorizations from additional regulators in Europe and the United States. Executing on an accelerated clinical development timeline, we anticipate commencing patient enrollment in the first half of 2017,” stated Pluristem Chairman and CEO, Zami Aberman. “We believe cell therapy holds great promise for patients with difficult to treat, life threatening conditions, such as CLI, and hope to play an important role in improving their health outcomes.”
The Phase III trial will evaluate PLX-PAD cells in the treatment of CLI in a double blind, randomized, placebo controlled trial. An estimated 250 patients with CLI Rutherford Category 5, who are unsuitable candidates for revascularization, will be enrolled. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM) two months apart. The primary endpoint will be time to amputation or death, allowing for a survival analysis that is well powered to deliver statistically significant results from a trial of this size.
About Critical Limb Ischemia
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at six months from diagnosis).
PETACH TIKVA, Israel, Oct. 13, 2016 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction, today announced it has submitted the clinical trial protocol for its Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH), to a leading Institutional Review Board (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.
“We are eager to commence our Phase II study in NAFLD/NASH, an indication for which there is no U.S. FDA approved drug. We view the submission of our clinical trial protocol as a major step forward,” stated Can-Fite CEO Dr. Pnina Fishman.
Based on the protocol that was submitted, Can-Fite’s Phase II study, designed by world renowned Key Opinion Leaders in the field of liver diseases, will be a multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of CF102 in the treatment of NAFLD/NASH. The study will enroll approximately 60 patients with NAFLD, with or without NASH, and will have three arms, including two different dosages of CF102 and a placebo, given via oral tablets twice daily. The study’s primary endpoints will be percent change from baseline in liver triglyceride (fat) concentration measured by nuclear magnetic resonance spectroscopy (NMRS) and safety. Secondary endpoints to be evaluated are the effects of CF102 on metabolic abnormalities in subjects with NAFLD, including body weight, waist circumference, serum triglyceride and high-density lipoprotein cholesterol levels, and serum liver transaminase. In addition, an assessment of the pharmacokinetics (PK) of CF102 and the A3 adenosine receptor (A3AR) biomarker will be evaluated prior to treatment and its correlation to patients’ response to the drug will be analyzed upon study conclusion. Furthermore, the exploratory objective of this study is to evaluate the effects of CF102 on relevant biomarkers, such as adiponectin, leptin, C-reactive protein (CRP), and liver stiffness as determined by Fibroscan. The trial design is based on preclinical studies showing CF102’s efficacy in reducing liver fat in NASH models as compared to placebo, improving liver function, and regenerating liver cells.
Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size by 2025.
JERUSALEM, June 21, 2016 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a developer of oral drug delivery systems, today announced that Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) is transferring a $6.5 million milestone payment from the previously-announced license and investment agreement between Oramed and HTIT. The payment follows Oramed’s positive top-line results from its Phase IIb U.S. Food and Drug Administration trial designed to evaluate the safety and efficacy of Oramed’s oral insulin capsule ORMD-0801 in patients with type 2 diabetes.
Per the terms of the agreement signed in December 2015, Oramed granted HTIT exclusive rights for commercialization of ORMD-0801 in Greater China. The up to $50 million license deal includes multiple milestone payments aggregating $38 million, with a $3 million upfront payment received by Oramed upon execution of the agreement, plus a $12 million investment made by HTIT in Oramed at $10.39 per share in December 2015. Oramed will receive a 10% royalty on net sales of ORMD-0801 and related commercialized products in Greater China.
“The completion of this milestone signifies our deepening partnership with HTIT as we move closer to bringing oral insulin to the vast and growing Chinese diabetes market,” said Nadav Kidron, CEO of Oramed.
“The positive Phase IIb data has further illustrated the huge potential this technology can have in China,” said HTIT CFO & Oramed Board Member Xiaopeng Li. “We are working diligently to lay the groundwork for the successful production and commercialization of ORMD-0801 focused on the Greater China market.”
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD™) technology is based on over 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
JACKSONVILLE, Florida, June 21, 2016 /PRNewswire/ —
TapImmune,Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today announced reaching a major milestone of dosing its first patient in a Phase 2 trial for triple negative breast cancer with its cancer vaccine TPIV 200. The first patient enrolled is being treated at the University of Maryland – one of 8 sites being used in this study, conducted and funded by TapImmune.
The randomized, open label Phase 2 study is expected to enroll a total of 80 subjects. The primary endpoints are dosing regimens and safety. Secondary endpoints are T-cell specific responses and evaluation of objective responses.
Dr. Glynn Wilson, Chairman and CEO of Tapimmune stated, “Enrolling and treating this first patient represents the start of a robust and intensive Phase 2 clinical program for our lead product TPIV 200, a Folate Receptor Alpha T-cell vaccine.”
TPIV 200 is currently being investigated in two other Phase 2 trials at the Mayo Clinic and at Memorial Sloan Kettering.
“Enrollment has started in the Phase 2 40 patient study at Memorial Sloan Kettering in collaboration with Astra Zeneca in late-stage ovarian cancer. In addition, the large 280 patient Phase 2 trial being run at the Mayo Clinic with a grant from the Department of Defense is expected to start enrollment later this year,” Dr. Wilson added.
TapImmune has received Fast Track Status and Orphan Drug Designation for TPIV 200. The Company plans to initiate a fourth Phase 2 clinical study, in late 2016, designed to treat platinum-sensitive ovarian cancer patients.
“The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible using the most cost-effective pathways. We are excited by the potential for this drug candidate and believe positive data from the Phase 1 study will be reflected in the results of our ongoing Phase 2 clinical investigations,” Dr. Wilson concluded.
Interested investors in TapImmune’s clinical studies can learn more by going to: http://www.clinicaltrials.gov
TEL-AVIV, June 24, 2016 /PRNewswire/ — Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced newly available data from its successfully completed Phase III study of KIT-302 suggest beneficial effects on kidney(renal) function. Damage to renal function is a serious side effect of NSAIDs.
The Company’s combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two U.S. Food and Drug Administration approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.
Further analysis of data obtained in the Phase III clinical trial, whose top line results were announced in December 2015,showed that celecoxib increased serum creatinine compared to placebo;impaired renal function is a major concern with nonsteroidal anti-inflammatory drugs (NSAIDs). In contrast, while amlodipine alone reduced serum creatinine (-2.55 umol/L), a greater reduction in plasma levels of creatinine was achieved in patients in the KIT-302 arm (-3.22 umol/L), suggesting better renal function.
Additional data supporting the conclusion that KIT-302 is beneficial to renal function were measurements of peripheral edema, a known side effect of calcium channel blockers, such as amlodipine. Peripheral edema was reported in 15.6% of patients receiving amlodipine but in only 8.2% of patients receiving KIT-302. These data suggest that KIT-302 protects against the widely recognized undesirable side effect of amlodipine in causing fluid retention by the kidneys.
Dr. Paul Waymack, Kitov’s Chief Medical Officer,said: “We are very pleased with the outcome of the renal function analysis. We believe it demonstrates that in addition to addressing hypertension side effects caused by celecoxib, KIT-302 also addresses fluid retention resulting from amlodipine: a known side effect caused by calcium channel blockers.”
“Given the potential marketing advantages of these findings,we intend to conduct a clinical trial designed to scientifically validate these beneficial renal effects in parallel with the New Drug Application we plan to submit at the end of 2016,” stated Chief Executive Officer Isaac Israel. The study may also provide an explanation for the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was higher than that observed with amlodipine alone.”
HAIFA, Israel, June 22, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI), (PSTI)/(PLTR), a leading developer of placenta-based cell therapy products, today reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.
Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys. The disease causes progressive muscle weakness, and leads to severe disability and death. There is currently no cure.
Following Pluristem’s announcement of positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury, the Association Duchenne Israel approached Pluristem with a request to study PLX-PAD cells in Duchenne muscular dystrophy. Pluristem donated PLX-PAD cells for the preclinical studies, and the association supported the research in cooperation with Science in Action Ltd.
The studies demonstrated that, in a mouse model of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by approximately 50% as compared to placebo. CPK levels were measured via a blood sample taken 5 days after each intramuscular PLX-PAD injection made at day 15 and day 29 of the study. Histological analyses of quadriceps and diaphragm muscles show PLX-PAD reduced levels of inflammation and necrosis, a type of cell death, and induced regeneration of muscle tissue.
Hila Krupsky, CEO of ADI, the Association Duchenne Israel, stated, “These preclinical data suggest that PLX-PAD cells could possibly be a breakthrough therapy to help treat symptoms of Duchenne muscular dystrophy. We are thankful for Pluristem’s donation of PLX-PAD and are eager to continue studying the cells since new therapeutic approaches are needed to manage this disease, save children’s lives, and give them hope and a chance for the future.”
“Because PLX-PAD cells have already displayed efficacy in muscle regeneration in a Phase II muscle injury study, we believe our cell therapy may potentially be beneficial in Duchenne muscular dystrophy in human clinical trials,” said Pluristem Chairman and CEO Zami Aberman. “We admire the commitment of the Association Duchenne Israel to find a cure for Duchenne muscular dystrophy, and we will work closely with them in an effort to develop a treatment for the children around the world who suffer from this disease.”