Celsion Corporation Announces ASCO 2015 GEN-1 Immunotherapy Phase 1b Results; BioCryst Announces Initiation of a Phase 1 Clinical Trial of BCX7353 Print E-mail
By Josh Gee   
Wednesday, 13 May 2015 19:39
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 13, 2015.
Celsion Corporation (NASDAQ: CLSN), a fully integrated oncology drug development company, announced results from its Phase Ib trial for GEN-1 in platinum-resistant ovarian cancer will be presented in poster session at the 2015 American Society of Clinical Oncology (ASCO) meeting in Chicago on Saturday, May 30th. GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.

Dr. Premal H. Thaker, M.D., associate professor at Washington University and Siteman Cancer Center in St. Louis and a principal investigator for the study, highlighted the results in an abstract titled, "A Phase I Study of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Pegylated Liposomal Doxorubicin) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer." The abstract is available on the ASCO website.

The Phase 1b dose escalating study enrolled 16 patients with platinum-resistant ovarian cancer and evaluated the safety, tolerability and efficacy of GEN-1 in combination with pegylated doxorubicin as well as the effect of intraperitoneal injection of GEN-1 on IL-12 and tumor cytokine levels. Patients received pegylated liposomal doxorubicin on day 1 and GEN-1 on days 1, 8, 15 and 22. This treatment regimen was repeated every 28 days in the absence of disease progression or unacceptable toxicity.

The findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response (PR) rate of 21% and a stable disease (SD) rate of 36%. The overall clinical benefit observed at the highest dose level was 86% (PR=29%, SD=57%). GEN-1 was well tolerated, with no dose limiting toxicities and no overlapping toxicities between GEN-1, its subsequent immune system activation and
pegylated doxorubicin.

"These clinical results are very encouraging, especially given the fact that patients suffering from advanced relapsed ovarian cancer have typically failed previous treatments and

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have limited treatment options for this aggressive cancer. GEN-1 is a novel immunotherapy designed to enhance the patient's immune system to help the body treat and
fight cancer," said Dr. Thaker. "I am pleased to be part of this important study and look forward to continuing my involvement with future trials of GEN-1 IL-12 immunotherapy in this underserved patient population."

Additional translational data measuring cytokine levels (IFN-gamma and TNF-alpha) at increased doses of GEN-1 is expected to be presented during the ASCO meeting. Since the maximum tolerated dose was not reached in this study, Celsion plans to expand its ovarian cancer development program to include two Phase 1 dose escalating trials evaluating GEN-1 in first line neoadjuvant ovarian cancer and in combination with Avastin® and Doxil® in platinum-resistant ovarian cancer.

"These data, particularly the overwhelmingly positive response rate seen at the highest dose level for GEN-1, are extremely impressive and underscore the potential clinical utility of this immunotherapy in ovarian cancer," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "In the second half of 2015, we plan to begin a Phase 1b study evaluating GEN-1 at higher doses in first-line neoadjuvant ovarian cancer. Based on compelling preclinical combination data, we also plan to initiate a Phase 1 dose escalating trial evaluating GEN-1 plus Avastin® and Doxil® in platinum-resistant ovarian cancer patients, a combination which has the potential to significantly improve treatment outcomes for these patients."


 
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BioCryst Pharmaceuticals, Inc.  (NASDAQ: BCRX) announced the initiation of a Phase 1 clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of orally-administered BCX7353 in healthy volunteers. Discovered by BioCryst, BCX7353 is a novel, selective inhibitor of plasma kallikrein in development for prevention of attacks in patients with hereditary angioedema (HAE). BioCryst has successfully completed nonclinical safety studies, as well as in vitro studies in which BCX7353 exhibited potent and selective inhibition of plasma kallikrein. The pharmacokinetic profile of BCX7353 in preclinical studies indicates its potential for once daily dosing.

"We are pleased to advance BCX7353 into the clinic and look forward to reporting results from this trial during the third quarter 2015. The successful development of a once daily, orally administered prophylactic drug that is safe and efficacious would be a game changer and a convenient treatment alternative for patients suffering from HAE," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst.

The main goals of the Phase 1 clinical trial are to assess safety, characterize plasma drug levels in healthy volunteers, and estimate the extent of kallikrein inhibition achieved after oral dosing of BCX7353.



 
Also Wednesday: 


 


Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced that David Johnson, Chief Executive Officer, and Brian Posner, Chief Financial Officer, will attend the 12th Annual Craig-Hallum Institutional Investor Conference on Wednesday, May 27, 2015 at the Depot Renaissance Minneapolis Hotel in Minneapolis, MN.

Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), through its wholly-owned subsidiary, Micron Products, Inc., a diversified contract manufacturing organization that produces highly-engineered, innovative medical device technologies requiring precision machining and injection molding, announced today results for its first quarter ended March 31, 2015.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the first quarter ending March 31, 2015.

Health Insurance Innovations, Inc. (HII) (Nasdaq:HIIQ), a leading developer, distributor, and virtual administrator of affordable health plans today announced financial results for the first quarter ended March 31, 2015. 

iGambit Inc. (OTCQB:IGMB), a diversified holding company, announced that on May 12, 2015 it entered into a Letter of Intent with United Fertility Centers of America (UFCA), which manages specialty outpatient fertility clinics.

Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that Keith Valentine, Chief Executive Officer of SeaSpine, will join Integra to present at the 2015 UBS Global Healthcare Conference.

Metabolix, Inc. (Nasdaq:MBLX), an advanced biomaterials company focused on sustainable solutions for the plastics industry, today reported financial results for the three months ended March 31, 2015.

Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development, today announced the presentation of three posters at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29-June 2, 2015 in Chicago, Illinois.

Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials.

Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, today announced its financial results for the quarter ended March 31, 2015.

Sphere 3D Corp. (Nasdaq:ANY), creator of the Glassware 2.0® container technology for application delivery, today announced it has signed a Master Purchase Agreement for virtualization products and related services with Novarad. 

Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, reports Q1 2015 financial results and will hold an Investor conference call on Wednesday, May 13, 2015, at 4:20 p.m. (EDT) to discuss the Company's financial results for First Quarter 2015 and provide an update on its business initiatives.



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