FREMONT, Calif., Feb. 25, 2015 (GLOBE NEWSWIRE) — WaferGen Bio-systems, (WGBS) announced today that it has produced positive results in a study aimed at validating the utility of its SmartChipTM technology for isolating and studying single cells via Next-Generation Sequencing (NGS). The study was conducted in collaboration with the Broad Institute, and the findings will be presented at the 2015 Advances in Genome Biology & Technology (AGBT) meeting to be held February 25-28 in Marco Island, Florida.

In a proof of concept study, WaferGen has engineered a solution for depositing single cells into the individual SmartChipTM wells in a directed fashion, to achieve far greater chip utilization. At this level of efficiency, each chip could produce more than 4,000 single cells for analysis. The cell’s genetic composition was then successfully analyzed with the NGS method by adapting the Single Cell RNA Barcoding and Sequencing (SCRB-Seq) technology pioneered by the Broad Institute. SCRB-Seq measurements have already resulted in critical discoveries of novel cell types that play an important role in disease mechanisms.

“We are pleased with the single cell transcriptome analysis results obtained with the SmartChip(TM) platform in this initial study,” said Dr. Chad Nusbaum, Scientific Director, Broad Technology Labs, and Co-Director, Genome Sequencing and Analysis at Broad Institute.

“Single cell analysis has the potential to play a significant role in the development of precision medicine, which is transforming healthcare,” said Ivan Trifunovich, President and Chief Executive Officer of WaferGen. “We expect our SmartChipTM technology will be able to yield a 50-fold increase in the production of single cells per chip at a fraction of the current per cell cost. We continue to expect to launch an Early Access Program for this technology during the second quarter of 2015.”

About WaferGen

WaferGen Bio-systems, Inc. is a life science company that offers innovative genomic solutions for clinical testing and research. The SmartChip MyDesignTM Real-Time PCR System is a high-throughput genetic analysis platform for profiling and validating molecular biomarkers via microRNA and mRNA gene expression profiling, as well as single nucleotide polymorphism (SNP) genotyping. The SmartChip TETM System is a novel product offering for target enrichment geared towards clinical Next-Gen sequencing (NGS). The Seq-ReadyTM TE System powered by SmartChipTM massively-parallel singleplex PCR technology, is an innovative one-step target enrichment and library preparation solution. The Company now also offers the Apollo 324TM product line used in library preparation for NGS. These three complementary technologies offer a powerful set of tools enabling more accurate, faster and cheaper genetic analysis based on Next-Gen Sequencing and Real-Time PCR.

HAIFA, Israel, Feb. 18, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today the positive results of a recently completed trial conducted by the U.S. National Institutes of Health (NIH) to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body’s ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome (ARS), a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs.

The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH’s first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem’s cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to U.S. Food and Drug Administration (FDA) approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA’s Animal Rule.

“Our PLX-R18 cell product was developed and targeted to become a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation. PLX-R18 cells are an off-the-shelf cell therapy product with a long shelf life. They do not require matching before use and can be administered through intramuscular injection. These features are important to facilitate rapid initiation of treatment on a large scale. The study results also support Pluristem’s unique approach of injecting cells intramuscularly to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly,” stated Zami Aberman, Chairman and CEO of Pluristem.

“We have had a productive working relationship with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which has independently conducted its studies with PLX-R18 cells provided by Pluristem,” Aberman added.

Pluristem is developing PLX-R18 cells for other potential indications including enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency. Trials for this indication are ongoing at Case Western University and Hadassah Medical Center. Data from the NIH studies in ARS are expected to benefit Pluristem’s development of its hematology program.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced the Ministry of Health Malaysia has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Malaysia. Malaysia is the 20th country to approve CEL-SCI’s Phase III trial, which now has over 350 patients enrolled.

“Our plan called for having the trial cleared and conducted in a total of 21 countries, the United States plus 20 other countries. We are almost there,” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.

DURHAM, N.C. and SAN DIEGO, Feb. 18, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, and OncoSec Medical Inc. (“OncoSec”) (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that they have entered into an agreement to evaluate the combination of the immunotherapy approaches developed by each company.

Under the agreement, Heat and OncoSec will jointly evaluate the preclinical efficacy of Heat’s proprietary gp-96-Ig based ImPACT immunotherapy platform using OncoSec’s core technology, ImmunoPulse, an investigational stage intratumoral DNA delivery platform.

“We are excited to initiate this collaboration with OncoSec, one of the leaders in the field of intratumoral DNA delivery,” said Taylor Schreiber, MD, PhD, Heat’s Vice President of Research and Development. “This collaboration with OncoSec reflects our desire to expand Heat’s ImPACT platform into DNA-based immunotherapies to stimulate immunity to both shared and private tumor antigens without introducing the complexities associated with personalized therapies,” Dr. Schreiber added.

“In this collaboration we will evaluate the efficacy of Heat’s proprietary DNA constructs with OncoSec’s clinical stage electroporation platform,” said Robert H. Pierce, MD, OncoSec’s Chief Scientific Officer. “Heat’s ImPACT platform is a unique approach that specifically activates tumor specific cytotoxic T-cells. We expect it will be effective with OncoSec’s proprietary intratumoral delivery platform that has already shown promising clinical activity in both local and distant tumors in patients with metastatic melanoma,” Dr. Pierce stated.

Heat and OncoSec are exploring this combination as part of their ongoing strategy to expand the application of their technologies to benefit cancer patients with unmet medical needs. Heat has two clinical stage programs based on the ImPACT platform, viagenpumatucel-L (HS-110) in a Phase 2 clinical trial in patients with non-small cell lung cancer and vesigenurtacel-L (HS-410) in a Phase 2 clinical trial in patients with non-muscle invasive bladder cancer. OncoSec’s core platform, ImmunoPulse, which is based on the intratumoral delivery of DNA IL-12, is currently in Phase 2 clinical trials, investigating the approach for treatment of metastatic melanoma, head and neck cancer, triple negative breast cancer, and cutaneous T-cell lymphoma.

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.

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.

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.