CEL-SCI IS CLEARED TO START PATIENT ENROLLMENT FOR ITS PHASE 3 CANCER IMMUNOTHERAPY TRIAL IN THAILAND

On June 8, 2015 CEL-SCI Corporation (NYSE MKT: CVM)("CEL SCI" or the "Company") reported that CEL-SCI is now cleared to start patient enrollment in Thailand in its ongoing Phase 3 trial with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer (Press release, Cel-Sci, JUL 8, 2015, View Source [SID:1234506548]). Thailand is the 24th country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

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"We have now completed enrollment of over 50% of the anticipated 880 patients in our Phase 3 trial and continue to expand the trial into more sites to increase the rate of enrollment. In the past month alone, we have added Spain and Italy as participating countries in our trial. We plan to have approximately 100 clinical centers around the world in about 25 countries screening and treating patients," stated CEL-SCI Chief Executive Officer Geert Kersten.

As of May 31, 2015, 463 patients had been enrolled in the global Phase 3 study.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. 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.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line (right after diagnosis, before surgery) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

Xenetic Biosciences Completes $3,000,000 Bridge Note Financing

On July 8, 2015 Xenetic Biosciences, Inc. ("Xenetic" or the "Company") (OTCQB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that it has completed a $3,000,000 bridge note financing (Press release, Xenetic Biosciences, JUL 8, 2015, View Source [SID1234537814]). The financing was concluded with OJSC Pharmsynthez ("Pharmsynthez"), a collaborative partner of Xenetic and an affiliate of Xenetic’s largest shareholder SynBio LLC ("Synbio") and was arranged directly between the managements of Xenetic and Pharmsynthez on a commission free basis.

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The $3,000,000 was received from the sale of a ten percent (10%) senior secured collateralized convertible promissory note due July 1, 2016 (the "Note"). The Note is convertible, in whole or in part, into shares of Common Stock of the Company at the option of Pharmsynthez. In addition, in connection with the sale of the Note, Pharmsynthez received certain five year warrants to purchase shares of Common Stock of the Company. Please refer to SEC form 8-K filed on July 8, 2015 for further material information regarding the bridge note financing.

"We are very pleased to have completed this important bridge note financing with a company that has been associated with Xenetic for fifteen years," said Scott Maguire, Chief Executive Officer of Xenetic. "Pharmsynthez is an important collaborator with Xenetic. The partnership covers six drug candidates currently in development in Russia which include indications for cystic fibrosis and obesity with the intention that the Company will eventually seek approval of these drug candidates in the global markets."

"These funds will allow us to continue with our plan to seek a listing of the Company’s shares on a national U.S. securities exchange that offers greater liquidity and will allow Xenetic to trade alongside its peers, therefore allowing greater exposure to the life science investment community. We believe that this financing, which was concluded with an affiliate of our single largest shareholder, reflects a belief in the potential of the Company’s core technologies. Our primary focus remains to improve the human condition by developing and offering safer and more effective treatments via the development of our portfolio of proprietary products. We are looking forward to the future with great confidence."

Xenetic Biosciences, Inc. ("Xenetic" or the "Company") (OTCQB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that it has completed a $3,000,000 bridge note financing. The financing was concluded with OJSC Pharmsynthez ("Pharmsynthez"), a collaborative partner of Xenetic and an affiliate of Xenetic’s largest shareholder SynBio LLC ("Synbio") and was arranged directly between the managements of Xenetic and Pharmsynthez on a commission free basis.

The $3,000,000 was received from the sale of a ten percent (10%) senior secured collateralized convertible promissory note due July 1, 2016 (the "Note"). The Note is convertible, in whole or in part, into shares of Common Stock of the Company at the option of Pharmsynthez. In addition, in connection with the sale of the Note, Pharmsynthez received certain five year warrants to purchase shares of Common Stock of the Company. Please refer to SEC form 8-K filed on July 8, 2015 for further material information regarding the bridge note financing.

"We are very pleased to have completed this important bridge note financing with a company that has been associated with Xenetic for fifteen years," said Scott Maguire, Chief Executive Officer of Xenetic. "Pharmsynthez is an important collaborator with Xenetic. The partnership covers six drug candidates currently in development in Russia which include indications for cystic fibrosis and obesity with the intention that the Company will eventually seek approval of these drug candidates in the global markets."

"These funds will allow us to continue with our plan to seek a listing of the Company’s shares on a national U.S. securities exchange that offers greater liquidity and will allow Xenetic to trade alongside its peers, therefore allowing greater exposure to the life science investment community. We believe that this financing, which was concluded with an affiliate of our single largest shareholder, reflects a belief in the potential of the Company’s core technologies. Our primary focus remains to improve the human condition by developing and offering safer and more effective treatments via the development of our portfolio of proprietary products. We are looking forward to the future with great confidence."

Cellectis Reaches Milestone in Servier Collaboration

On July 8, 2015 Cellectis reported the achievement of a significant milestone under the Company’s collaboration agreement with Servier, in the preclinical development of two next-generation product candidates in solid tumors (Press release, Cellectis, JUL 8, 2015, View Source [SID:1234506188]).

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Under the terms of the Company’s collaboration agreement with Servier, Cellectis is eligible to an undisclosed payment.

The collaboration announced in February 2014, is focused on research, development, and potentially commercialization of five product candidates targeting leukemia and solid tumors.

"We are very pleased with the productivity of this alliance enabling us to accelerate our development in the field of solid tumors", commented Mathieu Simon, MD, EVP Chief Operating Officer of Cellectis.

"We believe that immunotherapy will dramatically change the management of metastatic cancers. Our goal at Servier is to make these new technologies available for the largest number of cancer patients", commented Jean-Pierre Abastado, MD, Director Oncology Innovation Therapeutic Pole of Servier.

Navidea Biopharmaceuticals and Macrophage Therapeutics to Host Post-International KSHV Conference Summary Webcast / Call

On July 7, 2015 Navidea Biopharmaceuticals and its subsidiary, Macrophage Therapeutics reported they will hold a post-International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents conference webcast to provide investors with a more detailed look at the recently presented Manocept platform clinical and pre-clinical data and results disclosed in today’s press releases (Press release, Navidea Biopharmaceuticals, JUL 7, 2015, View Source;p=RssLanding&cat=news&id=2065126 [SID:1234506179]). The webcast will take place on July 7, 2015 at 1:00 pm EDT. Rick Gonzalez, Navidea’s CEO and Michael Goldberg, M.D., Macrophage Therapeutics’ CEO will host the call along with Michael S. McGrath, M.D., Ph.D., Professor, Departments of Laboratory Medicine, Pathology, and Medicine at the University of California, San Francisco who will discuss the data presented.

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Progenics Pharmaceuticals Announces Plans to Move Forward With 1404 Phase 3 Trial

On July 7, 2015 Progenics Pharmaceuticals reported details of its planned Phase 3 clinical trial for 1404, a developmental stage small molecule designed to help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA) (Press release, Progenics Pharmaceuticals, JUL 7, 2015, View Source [SID:1234506180]). Following recent End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), the design and key elements of a Phase 3 clinical trial for 1404 have been finalized.

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"The successful completion of our End-of-Phase 2 discussions with the FDA represents a milestone in our 1404 program," stated Mark Baker, CEO of Progenics. "Our Phase 3 study builds on our positive Phase 2 data, which established the broad potential of 1404 to detect local and metastatic prostate cancer in a wide range of patients, from low to high grade disease. Our Phase 3 program is designed to support commercialization in our initial target market for the 1404 imaging agent in the U.S. — patients with early disease who may be candidates for active surveillance."

The Phase 3 clinical trial is expected to enroll approximately 450 patients with biopsy-proven low-grade prostate cancer who are candidates for active surveillance but have planned to undergo radical prostatectomy (RP). The multicenter, multi-reader, open-label study will evaluate the specificity and sensitivity of 1404 to identify clinically significant prostate cancer. Histopathology of the tumor tissue will be used as the truth standard. An interim analysis will be performed after approximately one-third of the subjects have been treated and will include an analysis for futility and also evaluate the need for a sample size re-estimation.

Progenics expects the Phase 3 trial to commence by the end of this year.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.