DURHAM, N.C., Feb. 26, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, is today providing an update on its clinical program in non-muscle invasive bladder cancer (NMIBC) at a Key Opinion Leader (KOL) event being held this morning in New York.

Adding Monotherapy Arm To Ongoing Phase 2 Trial For HS-410 In The Treatment Of Non-Muscle Invasive Bladder Cancer

Heat announced it is adding a fourth monotherapy arm to its ongoing Phase 2 study evaluating HS-410 (vesigenurtacel-L) in the treatment of NMIBC. The decision was made after observing a vaccine-induced immune response in Phase 1 patients who received HS-410 after BCG (Bacillus Calmette–Guerin). Additionally, an intermittent global shortage of BCG provides an opportunity to evaluate the efficacy of single agent HS-410 in the treatment of NMIBC. The additional arm will be open-label and should not disrupt the timeline for reporting on the existing randomized portion of the trial. Heat currently anticipates enrolling and randomizing 75 patients into the first three clinical trial arms by the end of the third quarter 2015 as previously reported, and enrolling an additional 25 patients in the monotherapy arm by the end of 2015. Data from this study will aid in the design of Heat’s Phase 3 study of HS-410 in NMIBC. Depending on the results observed in the Phase 2 study, the Phase 3 may be designed to study HS-410 either as an adjunct to BCG or a replacement for BCG altogether.

The Company has also procured its own supply of BCG in order to ensure it has sufficient amount to continue treating patients and maintain its clinical program on schedule and to mitigate the risk of delays in the event of continued commercial shortages.

Forms Partnership With SUO-CTC To Support Accelerated Phase 2 Trial Enrollment

The Company also announced it has engaged with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), a cooperative group that represents urological oncologists and related specialists from over 160 institutions and hospitals in the United States and Canada, to support the goal of accelerating its Phase 2 enrollment in NMIBC and to begin planning for the Company’s Phase 3 trial. The ongoing trial is actively enrolling from SUO-CTC centers and other non-affiliated centers.

Melissa Price, Ph.D., Heat Biologics’ Vice President of Clinical and Regulatory Affairs, noted, “Our new monotherapy arm enables us to evaluate HS-410 as a single agent which may play an important role in our eventual Phase 3 design. This addition, combined with the accelerated enrollment through our collaboration with SUO-CTC, enables more rapid advancement of our clinical development strategy.

“We will be reporting on a number of critical milestones in 2015 including an analysis of the immune response of bladder and lung cancer patients and the completion of enrollment expected from our two Phase 2 trials in bladder cancer and NSCLC, all in the second half of 2015. We are enthusiastic about Heat Biologics’ potential to succeed in combating these cancers through our novel therapy.”

A live webcast and replay of the KOL event will be available at the “Investors” section of the Company’s website at http://ir.heatbio.com/events-presentations.

HAIFA, Israel, March 3, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today strong positive data from a preclinical study of PLX-R18 cells to improve outcomes of bone marrow transplantation. In the study, conducted in conjunction with Hadassah Medical Center’s Department of Bone Marrow Transplantation and Cancer Immunotherapy, mice with damaged bone marrow who received intramuscular injections of PLX-R18 cells together with a bone marrow transplant had significantly faster recovery of blood cell production compared to those who received a placebo with the bone marrow transplant. A rapid return to normal blood cell counts is critical for people who require a transplant to replace dysfunctional bone marrow because of diseases such as leukemia or other blood cancers. PLX-R18, Pluristem’s second product, is being developed to treat a range of hematologic indications including bone marrow deficiency and complications of bone marrow and umbilical cord blood transplantation.

The objective of the Hadassah trial was to compare the production of blood cells after intramuscular injection with PLX-R18 cells or placebo in the context of transplantation of hematopoietic stem cells obtained from bone marrow. Mice received lethal doses of radiation followed by either a low dose or a high dose of bone marrow cells and either PLX-R18 cells or placebo. Evidence of more rapid recovery was found at the two earliest data collection time points of the study. Nine days after transplantation with a low dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 had statistically significant increases in numbers of platelets and granulocytes as compared to controls; they also had more lymphocytes and total white blood cells, though these increases were not statistically significant. Nine days after transplantation with a high dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 also had statistically significant increases in platelet levels. One week later, at 16 days after a low dose transplantation, those treated with PLX-R18 cells had more platelets than controls, and those treated with PLX-R18 and a high dose of bone marrow had statistically significant increases in platelets, granulocytes and total white blood cells. After a bone marrow transplant patients cannot fight infections or prevent hemorrhage until white blood cell and platelet levels return to normal. The accelerated recovery of platelet and white blood cell levels demonstrated in this study could potentially have important clinical implications.

Alongside the study at Hadassah, a preliminary study was conducted by Hillard M. Lazarus, MD, a Professor of Medicine in the Department of Hematology and Oncology at Case Western Reserve University. The study was part of ongoing research there to test PLX-R18 for use in umbilical cord blood stem cell transplantation. Data in eight mice showed that six weeks after exposure to high doses of radiation, followed by transplantation with human umbilical cord blood cells, three out of four mice who received PLX-R18 cells survived compared to only one out of the four who received a placebo after transplant. At eight weeks after irradiation and transplantation the mice who received PLX-R18 each had a higher percent of hematopoietic cells (CD45+) in their peripheral blood than the surviving control subject. This early finding is encouraging as research continues at Case Western University to study the effects of PLX-R18 on the speed and success of engraftment of umbilical cord blood cells.

“A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful. For the transplant patient, the most critical period for hematopoietic recovery is in the days following the transplant. We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability,” stated Professor Reuven Or, Director of the Department of Bone Marrow Transplantation and Cancer Immunotherapy at Hadassah Medical Center and the study’s Principal Investigator.

Zami Aberman, Chairman and CEO of Pluristem, added, “Improving the outcomes of bone marrow and umbilical cord blood transplantation can have a significant impact on the treatment of a range of diseases, from blood cancers to immune and genetic disorders. We are happy with the data from preclinical studies of PLX-R18 in the context of transplantation and look forward to continuing our work in these indications with both Hadassah Medical Center and Case Western University.”

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that in February it has enrolled 25 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This follows January’s prior record. A total of 377 patients have been enrolled in the world’s largest Phase III study in head and neck cancer as of February 28, 2015.

“We are pleased to have achieved this consecutive month of record enrollment in 2015, particularly in light of the fact that February was a shorter month. During the month of February we also had a record number of patient screenings. During the month of February we also received clearance in the Philippines, Malaysia and Belarus to begin patient enrollment in those countries. This is expected to result in an even higher number of patients being enrolled in the study in March,” stated CEL-SCI Chief Executive Officer Geert Kersten.

The goal is to enroll a total of 880 patients through approximately 100 clinical centers in about 25 countries by the end of 2015.

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.

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.