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PETACH TIKVA, Israel, Feb. 4, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that all patients enrolled in its Phase II/III psoriasis trial for the Company’s drug candidate CF101 have completed the study’s 32 week treatment protocol. The trial has been completed and the final data is ready for analysis. The Company plans to publish top line results by the end of March 2015. Interim results from this Phase II/III trial and final results from the prior Phase II trial for CF101 in psoriasis were both positive.

“Following a thorough analysis of the data over the coming weeks, we look forward to announcing top line results on the efficacy and safety of CF101 in the treatment of moderate-to-severe plaque psoriasis. If these results are in line with the previously published favorable interim data, then we believe CF101 could offer a much-needed treatment alternative to patients living with psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

The psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. According to Global Data, the psoriasis treatment market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018.

This Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis. Can-Fite enrolled 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study cohort was comprised of three arms with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The primary efficacy endpoints are a statistically significant improvement in standard measures used by dermatologists to assess psoriasis including the Psoriasis Area Sensitivity Index (PASI) score and the secondary end points among others are the Physicians’ Global Assessment (PGA) score as well as various safety parameters.

Since Razor introduced the popular Razor scooter 15 years ago, the company has continuously reinvented the action sports category for kids, teens, and even adults. Now that the brand has branched out into electric rides, each year the carts and drifters continue to include more features. ClearVISION/Corporate Profile host Annamaria Stewart heads to the NY Toy Fair to speak with Ali Kermani Product Designer of the already in demand Crazy Cart XL, she also gives viewers a preview of Razor’s new Ground Force Drifter Fury and takes a look at some souped up rides for the smaller action sports fan.

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

To learn more about the rides featured in this episode visit:
WWW.RAZOR.COM

Highlights from the 2015 North American International Toy Fair at the Javits Center in New York City. ClearVISION/Corporate Profile Host Annamaria Stewart gives viewers a sneak peek at the newest toys hitting the shelves this year that you won’t want to miss. Make sure to stay tuned for our brand spotlight episodes on:
-Razor
-Crayola
-LEGO
-Madame Alexander
-WowWee
-Lionel Trains
-Skyrocket
-K’NEX
-Genesis
-Zing Toys
-Wicked Cool Toys
-MGA Entertainment
-Spin Master
-Jakks Pacific
-Uncle Milton
-NXT Generation

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

BioShares Founder, Paul Yook, talks about investing in the Biotech sector and his company’s exchange traded funds. To learn more about BioShares visit www.bioshares.com

HAIFA, Israel, Feb. 2, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapies, announced an important new finding from its Phase I/II clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury after total hip arthroplasty (THA). Data showed that six months after surgery the magnitude of improvement in muscle force of the contralateral (non-operated) gluteal muscle was approximately 40 times larger in patients treated with 150 million PLX-PAD cells than in those who received placebo, and the difference was statistically significant (19.4 vs 0.5 Nm, p=0.0114). Patients treated with 300 million PLX-PAD cells also showed a larger increase in muscle force than patients injected with placebo (9.48 vs 0.46 Nm, p=0.227). Pluristem further announced positive twelve-month safety data from the trial. These findings follow the January 21, 2014 announcement that the study had met its primary efficacy and safety endpoints. The primary efficacy finding was the change in maximal voluntary isometric contraction force of the gluteal muscle in the operated leg at six months after total hip replacement. There was a large and statistically significant improvement in patients who were injected with 150 million cells versus those who received placebo (31.1 vs 5.4 Nm, p=0.0067).

The study’s Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charite — Universitaetsmedizin Berlin, Germany, commented “I am impressed with the magnitude of the effect seen in the treated and contralateral legs. PLX cells demonstrated good safety and these newest findings suggest that intramuscular injection of PLX cells might potentially improve overall muscle functionality.”

Zami Aberman, Chairman and CEO, stated “It is very encouraging to have a large and statistically significant effect of PLX-PAD cells on our primary efficacy endpoint and also the unexpected finding of increased muscle strength in the non-operated leg. Although additional confirmatory studies are needed, these findings support our previous studies in which we showed that injection of PLX-PAD cells into muscle generates a systemic effect. The findings also open up new possibilities for the potential use of PLX-PAD cells. Based on these results, we intend to continue to develop PLX-PAD in orthopedic indications including sports injuries and muscle trauma, as well as muscle wasting and rehabilitation.”

The Phase I/II trial was a randomized, double blind, placebo controlled study conducted at the Orthopedic Clinic of the Charite — Universitaetsmedizin Berlin jointly with the Berlin-Brandenburg Center for Regenerative Therapies under the auspices of the Paul-Ehrlich-Institute (PEI), Germany’s health authority. The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty using the transgluteal approach. Post-operative healing is crucial for joint stability and function. The 20 patients in the study were randomized into three treatment groups. Each patient received injections in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells (n=7), the second was administered 300 million PLX-PAD cells (n=6), and the third received placebo (n=7). The primary efficacy endpoint was clearly met and the safety profile at 12 months was excellent.

The Business of Cannabis –
This is Not Your Parent’s High Times
Many of you have grown up as we did in the 60’s, 70’s, 80’s or even 90’s, when cannabis was commonly referred to as marijuana, maryjane or simply pot. It was associated with Woodstock, Bob Marley, Cheech and Chong, High Times Magazine, and Fast Times at Ridgemont High. Perhaps you may even remember an earlier time in which cannabis was propagandized and demonized, as in the 1936 movie Reefer Madness, a movie in which young teenagers are lured into purchasing marijuana from a couple living in sin and then through a gateway and ultimately down a dark path that leads to addiction, dark crimes, insanity, and even death. Well, as you all know now, the times they are a changin’, and cannabis has now been approved for medical use in over 25 states in the US, and legalized for recreational use in the states of Colorado, Washington, Oregon and Alaska. And it won’t stop there, as proposed legislative changes are taking place nearly every day.
There are a few things that make this industry very fascinating. First of all, of course, is the potential size of the market and industry. Secondly, from a legal perspective, there are unique issues related to the interplay and contradiction between Federal and State law. Thirdly, everywhere we go and whatever financial conferences we attend these days, there seems to be a buzz (pardon the pun) and excitement related to companies associated with this space. And lastly, for now, from a medical use perspective, we have never seen a medical product that is administered without regard to a particular dose, as in “take 2 of these and call me in the morning” or “take 1 every 6 hours for 7 days straight”. It is an anomaly.

Today, there is a burgeoning cannabis industry that some have referred to as “The Green Rush”. It is a growing tide spreading across the US, which in some ways harkens back to the end of prohibition or the way that the legalization of gay marriage has recently swept across many states of our nation. Perhaps more appropriately the issue of whether cannabis-related companies should or can be publicly listed and traded is more akin to the gambling industry, where federal and state laws are not in concert. A recent article published by the Washington Post cites to a report released by Greenwave Advisors, which it refers to as a “comprehensive research and financial analysis for the emerging legalized cannabis industry”. The article goes on to state that “…legal cannabis could be an industry with revenues of $35 billion by 2020 if cannabis is legalized at the federal level”. To put it further in perspective, this $35 billion figure represents more annual revenue than the NFL (currently $10 billion), and is roughly on par with current revenues for the newspaper publishing industry ($38 billion) and the confectionary industry ($34 billion). Thus, we are obviously talking about a potentially very big industry.

The historical uses of cannabis are well documented and many: cannabis has been used for medicine, food, fuel, paper, rope, maps, bricks, oil, paint, furniture and much more. In today’s market, in the states where cannabis has been legalized for recreational use, the primary focus of the market has become threefold, broken down into producers (or growers), processors (or labelers), and retailers. The secondary focus has become the many industries that have developed or are developing around those entities, such as real estate, agriculture, lighting, tourism, technology, research and development, e-commerce, banking and security (to name just a few).

Now once the foundation is set, combine the need and desire of entrepreneurs to raise money to fund their businesses or ideas in this space and you create a perfect storm. It is the interplay of the emerging business, fundraising and regulatory oversight which this Report is concerned. One of our primary focuses will be on companies considering ownership by individuals or entities outside of a small group in the legalized jurisdictions and will range to companies either considering to go public or that may have already crossed the divide and are public, listed and trading on the US capital markets (whether on a national securities exchange on the over-the-counter markets).

We have humbly set out to create a report that is intended to be a central place where readers can gather synthesized information about the regulatory state, development and emerging trends of this growing industry.

DURHAM, N.C., Jan. 26, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced positive data demonstrating substantially increased tumor infiltrating lymphocytes following treatment in its Phase 1 clinical trial of HS-410 in non-muscle invasive bladder cancer (NMIBC). The data are being presented today by Taylor Schreiber, MD, PhD, the Company’s Vice President of Research and Development, during the 7th Annual Phacilitate Immunotherapy Forum 2015(1), held in Washington, D.C.

Biopsies were collected at baseline and at the appearance of suspicious lesions from all patients enrolled in the Phase 1 trial. Analysis of tumor-infiltrating lymphocytes in one patient after surgery and induction BCG (bacillus Calmette-Guerin) followed by 6 weeks of HS-410 demonstrated an approximately 70-fold increase in CD8 expression (a marker for CD8+ killer T cells) within the tumor, which was not associated with any increase in CD4 expression (a marker for CD4+ helper T cells). When this patient returned at week 21, the trend continued and an approximate 750-fold increase in CD8 was observed, without any increase in CD4 expression. This high degree of specific immune infiltrate is consistent with Heat’s preclinical findings and the known mechanism of action for its gp96-Ig based vaccines. This patient currently remains disease-free.

The increase in levels of tumor infiltrating lymphocytes appeared to correlate with the clinical response observed with HS-410. In a second patient, a non-specific immune infiltrate was noted on week 7 to be slightly increased as compared to baseline, but which consisted of both CD4+ and CD8+ T cells. This patient returned with recurrent disease at week 13, when the repeat biopsy showed no further increase in the immune infiltrate.

“HS-410 has been engineered to specifically stimulate antigen specific cytotoxic T-cells (CD8+) that have anti-tumor activity,” stated Dr. Schreiber. “Observation of a highly polarized immune response in favor of CD8+ T cells in a patient where residual disease was eliminated is encouraging, supports the mechanism of action of our ImPACT vaccines, and may represent a treatment effect. We are still evaluating many patients from the Phase 1, and in an ongoing Phase 2 study, and are hopeful to see similar responses in many more patients. We look forward to presenting additional data from this trial in the future.”

The Phase 1 trial enrolled patients who have had Ta, T1, or Tis NMIBC (tumor removed). For the open-label Phase 1 trial to assess safety and tolerability, 10 patients received 5-6 weekly doses of BCG before HS-410 administration. After BCG treatment, patients received a low dose of HS-410. Patients were given 12 weekly injections followed by 3 monthly injections. HS-410 was well-tolerated with no serious adverse events, allowing Heat to initiate its current Phase 2 trial. An interim analysis of the 10 patients in Phase 1 is expected in the first half of 2015.

PETACH TIKVA, Israel, Jan. 27, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today reported it has received positive data regarding its CF602 drug candidate in preclinical studies conducted by a third party.

CF602 was tested in an experimental animal model of diabetic rats, which similar to diabetic patients, suffer from sexual dysfunction. Erectile dysfunction was assessed by monitoring the ratio between intra-cavernosal pressure (ICP) and mean arterial pressure (MAP) as a physiological index of erectile function. The ICP/MAP for the CF602 treated group improved by 118% over the placebo group. This data is similar to that achieved earlier by sildenafil (Viagra) in preclinical studies. In addition, treatment with CF602 reversed smooth muscle and endothelial damage, in a dose dependent manner, leading to the improvement in erectile dysfunction.

CF602 is a novel A3 adenosine receptor allosteric modulator, enhancing the affinity of the natural ligand adenosine to its A3 adenosine receptor.

“Our drugs, based on the A3 adenosine receptor platform, have been administered to over 1,200 patients in clinical studies and shown an excellent safety profile. We believe this has the potential to give us a huge advantage over current drugs in the erectile dysfunction market which are known to have adverse effects, hampering diabetic patients and other populations from using them on a daily basis,” stated Can-Fite CEO Dr. Pnina Fishman.

Based on positive results from this preclinical study, the Company recently announced its plans to initiate a pre-clinical development program for CF602 in order to file an investigational new drug application (IND) with the U.S. Food and Drug Administration to allow human Phase I studies for the indication of sexual dysfunction.

Can-Fite has a strong intellectual property position which includes an issued “composition of matter” patent and other pending patent applications protecting the use for sexual dysfunction. GlobalData estimates the value of the erectile dysfunction therapeutic market to be approximately $2.7 billion with few drugs in the market which include Viagra, Cialis and Levitra.

JERUSALEM, January 16, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the Israel Patent Office has granted the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Exenatide.”

About ORMD-0901 – Oral GLP-1

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form only, and is indicated for treatment of type 2 diabetes. Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss. Oramed’s oral GLP-1 capsule based on the company’s PODTM technology could significantly increase compliance and become a valuable tool in the treatment of diabetes.

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). Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).

WILMINGTON, Mass., Jan. 13, 2015 /PRNewswire/ — Implant Sciences Corporation (IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today its QS-B220 explosives and drugs trace detector has received regulatory approval in Russia for transportation. This approval covers various forms of transportation in Russia, including aviation, rail, and subways. In addition, both the QS-B220 and QS-H150 have also received the Customs Union Declaration of Conformity certification. These approvals allow Implant Sciences to sell the units to customers in Russia, Belarus, and Kazakhstan for the next five years, subject to U.S. export approval.

“We are pleased to have received these approvals, particularly the transportation approval for the QS-B220, which is the Russian equivalent of the TSA in the United States,” stated Glenn D. Bolduc, President and CEO of Implant Sciences. “Although currently the U.S. government, through the Department of Commerce – Bureau of Industry and Security, has placed a hold on the issuance of new export licenses authorizing the export or re-export of items to Russia, this hold does not affect existing licenses issued by BIS. Implant Sciences currently holds export licenses for hundreds of systems to Russia, and we believe that these Russian approvals will have a long-term positive impact in terms of the opportunity in the Russian ETD market for our Company.”

Russia is the largest country in the world by territory, with the railway system being its key mode of transportation. With an operational length of over 85 thousand kilometers as at the end of 2013, it is the third largest rail network in the world in terms of track length. Furthermore, it is estimated that the Moscow Metro will spend $116 million on security for the passenger screening.

About the QS-B220 Desktop Explosives and Drugs Trace Detector

The QS-B220 uses Ion Mobility Spectrometry (IMS) to rapidly detect and identify trace amounts of a wide variety of military, commercial, and homemade explosives as well as illicit drugs. With significantly lower maintenance requirements than competing systems, the QS-B220 can be deployed for a much lower total cost of ownership than other approved products. Featuring a radioactive material-free design, push-button maintenance and diagnostics, and a patented inCal™ internal automatic calibration system, the QS-B220 brings new levels of performance and convenience to desktop trace detection users with unsurpassed ease of use.