DELRAY BEACH, Fla., April 16, 2012 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCBB:PSID.OB - News), an emerging growth company and developer of advanced technologies for diabetes management as well as sophisticated airborne bio-threat detection systems for America's homeland defense, today announced significant progress with the initial deployment of its FDA-cleared iglucose(TM) mobile health system for diabetes management. The iglucose System is currently being trialed by a leading health insurer, a large consumer healthcare products company and an international telecommunications provider. The Company also recently announced the use of iglucose in a trial with a leading global pharmaceutical company.
PositiveID's FDA-cleared iglucose System is a convenient and easy-to-use wireless solution designed to empower individuals with diabetes to become more engaged in the self-management of their condition. iglucose seamlessly communicates blood glucose data from glucometers to the iglucose diabetes management portal, where reports are generated and can be shared with family members and healthcare professionals, making it possible to improve care in a cost-effective manner. The iglucose system communicates according to the user's preferences via online access, email, fax or SMS text. iglucose eliminates the burden of keeping logbooks and enables individuals with diabetes to proactively take control of their glucose levels and treatment regimens. iglucose does not require the use of a cell phone or a wireless plan.
"Many large organizations are currently trialing iglucose, from one of the largest health insurers in the U.S., to one of the largest consumer healthcare products companies in the world," stated William J. Caragol, PositiveID's Chairman and CEO. "We are providing this progress report following our announcement last week that we made iglucose available for pre-order for consumers. We received a very positive response and therefore want to update the investor community as well as those with diabetes about our next steps."
The iglucose system collects and transmits stored data from a variety of FDA-cleared blood glucose meters such as Johnson & Johnson LifeScan(R), Abbott FreeStyle(R), Bayer Contour (R), and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. PositiveID is continually adding to this list of supported glucose meters. For more information on iglucose, visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation is an emerging growth company and developer of advanced technologies for diabetes management and rapid medical testing, as well as airborne bio-threat detection systems for America's homeland defense. Its wholly-owned subsidiary, Microfluidic Systems, or MFS, is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats at high-value locations, as well as analyze samples in a medical environment.
For more information on PositiveID, please visit www.PositiveIDCorp.com.
SAN DIEGO, CA--(Marketwire -04/16/12)- La Jolla Pharmaceutical Company (OTCQB: LJPC.PK - News) (Pinksheets: LJPC.PK - News) today announced initial product development plans for advancing GCS-100, its first-in-class inhibitor of galectin-3.
On January 20, 2012, we announced the acquisition of GCS-100 from Solana Therapeutics, Inc. This acquisition makes us a leader in the development of therapeutics that target galectin-3, a protein that has been shown to play an important role in chronic organ failure and cancer. The Company believes that GCS-100 is the most advanced galectin-3 inhibitor in development and plans to initially focus its development activities in two areas of great unmet medical need: chronic kidney disease and cancer.
Chronic Kidney Disease: A Significant Unmet Medical Need
The developed world is suffering an epidemic of diabetes and hypertension, both of which cause kidney damage, chronic kidney disease and end-stage renal disease (ESRD). The National Institute of Diabetes and Digestive and Kidney Diseases estimates that 20 million United States adults suffered chronic kidney disease in 2008 [REF 1]. Of these 20 million people, 547,982 received treatment for ESRD and an estimated 88,630 died of ESRD. In total, a staggering $40 billion was spent in the United States on ESRD in 2008. ESRD leads to the need for dialysis and kidney transplantation. In 2008, 16,557 patients in the United States received a kidney transplant. Of these, 10,551 received a kidney from a non-living donor (cadaveric transplant). These transplants are at much higher risk of being rejected due to an attack by the patient's immune system. Despite improvements in therapies designed to suppress rejection by the recipient's immune system, 10% of patients receiving cadaveric transplants suffer acute rejection episodes which increases the risk of ultimate graft failure. In addition, the immunosuppressive therapies given to these patients increase the risk of infection and cancer due to sustained immune suppression.
The Role of Galectin-3 in Chronic Kidney Disease
Chronic organ failure involving the kidney, heart, liver or other organs is caused by fibrosis, or scar formation. Galectin-3 is normally found in most tissues at low concentration, but is up-regulated (increased) in response to injury. Several recent studies conducted by leading investigators have shown that increased circulating levels of galectin-3 are associated with poorer outcomes in patients with heart and kidney failure [REF 2, 3]. Furthermore, a number of preclinical studies have demonstrated a direct, causal role of galectin-3 in tissue fibrosis leading to kidney failure. Specifically, animals that have been genetically engineered to lack galectin-3 do not produce harmful scar formation after kidney injury or transplantation and have better kidney function. [REF 4, 5, 6].
GCS-100 for Chronic Kidney Disease
By inhibiting galectin-3, GCS-100 has the potential to delay or even reverse organ failure by preventing tissue fibrosis. GCS-100 has already been studied in more than 100 patients and has demonstrated an excellent side effect profile with mild-to-moderate, self-limiting rash as the principal side effect observed in clinical trials to date. We plan to initiate a clinical trial this year to study GCS-100 in cancer patients with renal (kidney) insufficiency. We will be evaluating several end points related to renal function, as well as looking at the effect of GCS-100 on plasma levels of galectin-3 and their relation to renal function.
Cancer
The American Cancer Society estimates that over 1.6 million new cases of cancer will be diagnosed in the United States in 2012 [REF 7]. The lifetime chance of developing cancer is 1:2 for men and 1:3 for women. Cancer strikes all ages, races and segments of our society. Despite significant advances in recent years, cancer is the second leading cause of death in the United States, responsible for almost 600,000 deaths annually. Additionally, traditional therapies for cancer do not specifically target the cancer cells and therefore cause significant debilitating side effects. In an effort to specifically target the cancer cells, biologists and drug developers have long sought to harness the patient's own immune system for the treatment of cancer. In recent years, progress has been made on this goal with the successful development and approval of Yervoy™ (ipilimumab) for advanced-stage melanoma and Provenge™ (sipuleucel-T) for the treatment of advanced-stage prostate cancer. These therapies work by stimulating or assisting the body's active immune response to fight the tumor. Active immune therapies cause the patient's immune system to adapt to the ever-present changes in the tumor. In contrast, passive monoclonal antibody therapies do not stimulate the patient's own immune defenses to combat the cancer and therefore mutating cancer cells can often evade these therapies. Immunotherapy approaches hold particular promise to treat the cancer while sparing normal tissues.
The Role of Galectin-3 in the Body's Immune Response to Cancer
A number of studies have suggested that galectin-3 impairs the active immune system's attack on cancer [REF 8, 9]. Specifically, these publications have shown that cancer cells secrete high levels of galectin-3, which serves to deactivate the body's immune response to the cancer cell.
GCS-100 for Cancer
By antagonizing galectin-3, GCS-100 disrupts this mechanism of immune evasion and has the potential to activate the patient's immune system to fight cancer. Preclinical studies of GCS-100 have shown that GCS-100 can reactivate killer T-cells directed at the cancer that have been silenced by galectin-3 [REF 9]. Because GCS-100's mechanism of immune activation is complementary to those of approved cancer immunotherapies Yervoy and Provenge, there is the potential that GCS-100 will work in synergy with them and similar agents. GCS-100 has been studied in over 100 cancer patient and has demonstrated activity in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and renal cell cancer (RCC). We believe that the safety profile of GCS-100 to date has been excellent, with mild-to-moderate, self-limiting rash as the principal side effect.
We plan on evaluating GCS-100 in combination with Yervoy in preclinical models. This work builds on previous studies in which GCS-100 was shown to be additive or synergistic with several chemotherapeutic and targeted anti-cancer agents. Following successful completion of this study, we plan on initiating a clinical trial in melanoma.
Summary
We are dedicated to developing safe and effective therapies for significant life-threatening diseases including organ failure and cancer. We are attacking these fatal disorders by targeting galectin-3, a member of the galectin family of proteins that is implicated in their pathology. Our lead product candidate against galectin-3, GCS-100, has been tested in more than 100 patients and is generally well tolerated. We have an experienced management team dedicated to accomplishing our corporate milestones, as well as sufficient cash to execute on these near-term activities. Please visit us at http://www.ljpc.com.
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