Immunomedics Provides Update On Phase 2 Study Of Isactuzumab Govitecan; Hemispherx Reports New Evidence of Ampligen(R) Print E-mail
By William Kent   
Thursday, 30 October 2014 19:00

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 30, 2014.

Immunomedics, Inc., (Nasdaq:IMMU) announced isactuzumab govitecan (IMMU-132), the Company's proprietary solid-tumor antibody-drug conjugate (ADC), continues to produce encouraging results in a Phase 2 clinical trial in heavily-pretreated patients with diverse, metastatic solid cancers. The provisional results were presented by Dr. David M. Goldenberg, Chairman, Chief Scientific Officer, and Chief Medical Officer, at the 5th Annual World ADC Summit in San Diego, CA.

In 113 patients who have received at least one dose of isactuzumab govitecan, treatments with the ADC resulted in at least 64 patients (57%) with partial responses and disease stabilization. All lesions were measured by computed tomography (CT) based on RECIST 1.1 criteria. The major responses were observed among patients with 6 different advanced cancers, including triple-negative breast, small-cell and non-small-cell lung, colorectal, esophageal, and urinary bladder cancers.

The ADC was well tolerated at the Phase 2 dose used in the trial expansion, with neutropenia being the major toxicity, and about 10% of patients having grade 3 and 4 other toxicities. This suggests a higher therapeutic index (ratio of therapeutic benefit to toxicity) than historical results with irinotecan, SN-38's parent compound.

"We are most encouraged with the results in patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, especially in these patients who have late-stage diseases," remarked Cynthia L. Sullivan, President and Chief Executive Officer. "We plan to complete the Phase 2 study before the end of this year. Discussions with key opinion leaders, as well as potential corporate partners, on the further development of this valuable agent are ongoing," Ms. Sullivan added.

Isactuzumab govitecan is made up of SN-38, the active metabolite of irinotecan, conjugated to the Company's humanized anti-TROP-2 antibody. TROP-2 is expressed by many human tumors, such as cancers of the breast, cervix, colon and rectum, kidney, liver, lung, ovary, pancreas, and prostate, but with only limited expression in normal human tissues. Preclinical studies have indicated that isactuzumab govitecan delivers up to 135-times the amount of SN-38 to a human pancreatic tumor xenograft than when irinotecan is given. In patients who relapsed or were refractive to prior topoisomerase I or II inhibitors, this ADC demonstrated subsequent activity, suggesting that it can overcome resistance to such inhibitors, including irinotecan.

In addition to isactuzumab govitecan (IMMU-132), the Company is also developing another SN-38 based ADC, labetuzumab govitecan (IMMU-130), for the treatment of patients with metastatic colorectal cancer. The clinical study of this agent is advancing into a Phase 2 trial, with some patients under therapy for many months and showing long-term disease control after failing prior irinotecan-containing regimens. Here again, despite the frequent dosing, the ADC appears to be well tolerated by patients, with transient and reversible neutropenia, and manageable diarrhea the major side effects, which were mild and irregular.


Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
, reported a new peer reviewed publication entitled, "The Quest for Effective Ebola Treatment; Ebola VP35 is an Evidence-Based Target for dsRNA Drugs" in the Nature Group's current issue of Emerging Microbes and Infections (October 29, 2014). This publication was authored by affiliates of Hemispherx. The publication provides an illustration of the crystallographic coordinates of a truncated VP35 complex with dsRNA.

Death from Ebola virus (EBOV) infection is associated with markedly impaired coagulation and innate immunity cascades, increased production of pro-inflammatory cytokines, profound immune suppression resulting in peripheral T lymphocyte apoptosis, and a lack of adaptive immunity (Fields Virology 923-956, 2013). By contrast, survivors of infection by EBOV develop an effective immune response with the production of EBOV neutralizing antibodies. Early events in EBOV infection influence the patient's ability to develop an effective immune response. The success of EBOV replication is dependent on viral inhibition of initial innate immune responses to infection. Disarming innate immune responses is a common mechanism employed by highly pathogenic human viruses, including those of the influenza and coronavirus families (Antiviral Res 100:615, 2013). EBOV is one of the more successful of the emerging highly pathogenic viruses in evasion of innate immune mechanisms.

Critical Role of VP35 in High Death Rates -- VP35 is a multifunctional major virulence protein that is indispensable for EBOV replication. Double-stranded RNA (dsRNA) is a necessary component of viral replication, which initiates systemic signaling cascades that normally activate interferon (IFN) regulatory factors leading to the production of IFN-α/β (type I IFNs). VP35 inhibition of dsRNA effectively disarms essential components of the innate immune response. VP35 binds to sequence-independent dsRNA, resulting in the suppression of multiple steps in the IFN signaling cascade, which otherwise would provide a broad antiviral state by activation of both the innate and adaptive arms of the immune response. Multiple investigators have demonstrated that VP35 binds dsRNA (Antiviral Res93:354, 2012) and molecular crystallographic analysis has demonstrated that binding is achieved by non-covalent bonding with the dsRNA phosphodiester backbone and thus shielding of viral produced dsRNA from host antiviral signaling pathways (Nat Struct Mol Biol 17:165, 2010). The inavailability of viral produced dsRNA during replication results in an increased virus load and its consequences. Thus, the VP35 dsRNA interaction is an evidence-based target for antiviral interruption of EBOV, potentially ameliorating the pathogenesis of EVD.

Therapeutic dsRNA May Overcome the Lethal dsRNA Sequestration Action of VP35 and Reverse the "dsRNA Deficiency" Associated with Ebola -- Various forms of dsRNA have been studied as inducers of type I IFNs. Although the original dsRNA studied for efficacy in humans, poly I:poly C, was found to induce serious adverse events in humans that limited pharmaceutical development, several derivatives have survived the rigors of animal and clinical testing. Poly I:Poly C12U (rintatolimod, Ampligen®) was designed as an IFN inducer with a markedly reduced incidence of adverse events compared to the parent compound poly I:poly C and has demonstrated antiviral activity against a wide variety of DNA and RNA viruses in pre-clinical testing, including SARS (Severe Acute Respiratory Syndrome). Multiple mechanisms may be involved in the antiviral activity of rintatolimod in its predicted EBOV utility. These include direct induction of innate immunity as a TLR3 agonist, competition for VP35 binding with dsRNA allowing activation of innate immune responses, and/or serve as a required dsRNA cofactor for IFN induced enzymes that function in the innate immune cascades triggered by viral infections. In contrast to drugs under intensive development to help contain this global crisis, sequestration of dsRNA is non-sequence dependent with the phosphodiester backbone freely available for VP35 binding. Since EBOV has been demonstrated to be mutating rapidly in this epidemic (Science 345:1369, 2014), anti-EBOLA agents that depend on sequence maintenance (vaccines, monoclonal antibodies, active site viral enzyme inhibitors) may be at risk following clinical development even with crisis activated reductions in regulatory requirements. 

A Secondary Efficacy Mechanism -- In animal studies, Ampligen® was also efficacious by a second mechanism as an adjuvant for highly pathogenic avian influenza virus vaccines, and this drug is now being evaluated as an adjuvant in a variety of cancer vaccine trials. Epitope expansion has also been observed with Ampligen® applied intranasally in man (Vaccine 32(42):5490, 2014) and this property may also result in antibody levels to accelerate recovery from Ebola and evade mutational inhibitory properties.

Evidence Based Experimental Therapeutics -- The use of experimental pharmaceuticals beyond phase I in FDA-sanctioned clinical trials helps ensure the availability of products with established safety profiles sufficient for open-label clinical testing and analysis of efficacy. The use of potential drugs already in clinical trials also helps ensure a reliable supply of clinical- grade drugs, which removes the ethical dilemma of patient selection for treatment (New England J Med 371:1066, 2014). In third world countries, with limited facilities for medical intervention, protecting the individual from exposure to Ebola containing bodily fluids may be achieved by heightening immunity on the majority of mucosal surfaces, as by the potential use of intranasal sprays of Ampligen®. Hemispherx is working with regulatory authorities to potentially inhibit further escalation of this global crisis. 

On September 29, 2014, Hemispherx announced a series of collaborations designed to determine the potential effectiveness of Alferon® N and Ampligen® as potential preventative and/or therapeutic treatments for Ebola related disorders ( ).


Also Thursday:

AB Science SA (NYSE Euronext - FR0010557264 - AB)
, a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), announces the publication of preclinical study results with masitinib in ischemic stroke.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced its financial results and business highlights for the third-quarter of 2014.

Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced financial results for the third quarter ended September 30, 2014.

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today financial results for the third quarter ended September 30, 2014.

Avalanche Biotechnologies, Inc. (Nasdaq:AAVL)
, a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced that Linda C. Bain, Chief Financial Officer, will participate in the "From Successful IPOs to Clinical Success: A Focus on New Crop of Companies Focused on Disorders of the Eye," panel discussion at Nomura's Biotechnology Conference on Thursday, November 6, 2014 at 10:00 am EST in Boston, MA.

AXIM Biotechnologies (OTC:AXIM)
proudly announces its strategic focus: bring to market global innovative solutions that set the "green standard" in the industrial hemp industry.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the third quarter ended September 30, 2014.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that it will report third quarter 2014 financial results on Monday, November 10, 2014.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care (POC) diagnostic tests and technology, today announced that the U.S. Food and Drug Administration (FDA) granted a CLIA Waiver for the Company's DPP® HIV 1/2 Assay.

Endologix, Inc. (Nasdaq:ELGX)
, developer and marketer of innovative treatments for aortic disorders, today announced financial results for the three and nine months ended September 30, 2014.

Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that the Company will release financial results for the third quarter ended September 30, 2014 on Thursday, November 13, 2014, before the market opens.

Fibrocell Science, Inc. (Nasdaq:FCSC)
, an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that it will report third quarter and the first nine months of 2014 financial and operating results on November 7, 2014.

Greatbatch, Inc. (NYSE:GB)
, today announced results for its third quarter ended October 3, 2014 highlighted by 23% growth in GAAP diluted EPS and 12% growth in adjusted diluted EPS.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced that Merit and Bard Access Systems have settled a dispute regarding the distribution of the SecureLoc™ Safety Introducer Needle.

Micron Products, Inc. (Micron)
, a wholly-owned subsidiary of Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), announced today it has appointed medical device industry professional Albert (Bert) McGrath as the Company's Vice President of Operations, effective November 1.

MTBC (Nasdaq:MTBC)
, a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that the company will release the results for its third quarter ended September 30, 2014 before the market opens on Wednesday, November 12, 2014.

NeoStem, Inc. (Nasdaq:NBS)
, a biopharmaceutical company developing novel cell based therapeutics designed to prevent, treat or cure disease, today announced financial results for the third quarter of 2014 and also described important expected milestones related to its clinical programs.

Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that it and LifeCell™ Corporation ("LifeCell"), an Acelity company, have agreed to transfer all marketing and distribution rights to the SPY Elite® System from LifeCell to NOVADAQ.

Pain Therapeutics, Inc. (Nasdaq:PTIE)
today reported financial results for Q3 2014. Net loss in Q3 2014 was $3.5 million, or $0.08 per share, compared to a net loss in Q3 2013 of $0.8 million, or $0.02 per share.

Premier, Inc. (Nasdaq:PINC)
has the best overall performance in providing services to support accountable care organization (ACO) initiatives, according to KLAS, an independent healthcare research firm.

Stereotaxis, Inc. (Nasdaq:STXS)
today announced that it will release financial results for its 2014 third quarter ended September 30, 2014 on Wednesday, November 5, 2014 after the close of the U.S. financial markets.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the European Commission has granted orphan medicinal product designation for recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (KRN23 or UX023) for the treatment of X-linked hypophosphatemia (XLH). XLH is an inherited metabolic bone disease characterized by short stature, skeletal deformities, bone pain, fractures, and muscle weakness.

Vital Therapies, Inc. (Nasdaq:VTL)
, a biotherapeutic company developing ELAD®, a cell-based therapy targeting treatment of acute liver failure, will release its third quarter 2014 financial results after the market closes on Thursday, November 13, 2014.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced financial results for the third quarter ended September 30, 2014, and provided an update on the company's product development activities.

ZS Pharma (Nasdaq:ZSPH)
, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that data from ZS003, a pivotal Phase 3 trial of ZS-9 (sodium zirconium cyclosilicate), its investigational treatment for hyperkalemia, will be presented in multiple presentations at the American Society of Nephrology (ASN) Annual Meeting in Philadelphia, Pa. which is taking place from November 11 to 16, 2014.

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