Mike Havrilla     twitter.com/mikehavrilla       

Despite the setbacks and pitfalls experienced by early-stage pioneers in the cancer immunotherapy / therapeutic cancer vaccine space such as Cell Genesys, Favrille, and Genitope; recent advancements and study results are encouraging while Dendreon (NASDAQ: DNDN) awaits a FDA decision that is expected by May 2010 for its prostate cancer vaccine, Provenge, which is poised to become the first active cellular immunotherapy approved by the Agency to harness a patient's own immune system in the fight against the disease.

Last week, a group of Harvard bioengineers and immunologists reported encouraging preclinical results for a novel delivery mechanism for therapeutic cancer vaccines that utilizes tiny plastic disks embedded with tumor-specific antigens and implanted under the skin to mobilize the immune system to attack melanoma (skin cancer) tumors in mice. The implants utilized in this study were made of an FDA-approved biodegradable polymer that is just 8.5 millimeters in diameter and highly porous (90% air) to make them highly permeable for interaction with cells of the immune system.

Quantum Immunologics (QI) is a privately held, clinical-stage company that is engaged in the research, development, and production of innovative therapeutic and diagnostic products that are based on the universal cancer antigen (oncofetal antigen or OFA) that also had news last week in the form of a pact with Auburn to develop a cancer immunotherapy product for use in animals.

The BioMedReports.com research download section and the ProActive News Room Landing page for QI have been updated to reflect my new 27-page profile report for QI and an overview of other cancer vaccines in development, following news last week of a collaboration agreement with Auburn University to bring its novel cancer immunotherapy to the veterinary market. The parties have agreed to form a new, independently-funded and jointly-owned company to accomplish its goal with operations expected to commence by mid-2010.

Favorable growth trends for the pet and animal care industry are outlined below and the pact with a leading veterinary university further validates QI's leadership role as an innovator of cancer therapeutics / diagnostics based on the OFA antigen as a universal bio-marker of the disease in both humans and animals.

1.) total pet industry spending in the U.S. is estimated at $45.4 billion in 2009, which includes $12.2 billion in vet care spending;

2.) according to the 2009-2010 National Pet Owners Survey, 62% of U.S. households own a pet, which equates to 71.4 million homes;

3.) the worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20 billion in 2008, experiencing growth of 26% from 2003.

QI's approach to cancer immunotherapy involves sensitizing the dendritic cells from a patient's own blood to recognize and direct the body's immune system to attack breast cancer sites in a targeted effort to eradicate or stabilize the disease. This approach does not involve breast surgery (e.g. complete or partial removal of breast tissue), chemotherapy, or radiation - with the goal of eliciting a targeted immune response directed at cancer cells which may prove to be more effective and safer (i.e. a few days of temporary flu-like symptoms following treatment as the immune system attacks the cancer cells) than existing treatments.

Dendreon follows a similar approach for prostate cancer as it prepares to become a commercial-stage company with a pending FDA decision for Provenge (sipuleucel-T) expected by 5/1/10, following positive Phase 3 results announced earlier this year. Provenge is derived from a patient's own immune system (dendritic cells, hence the name Dendreon) and is poised (upon FDA approval) to become the first of a new class of therapeutics called active cellular immunotherapies (ACI) which are also referred to as therapeutic cancer vaccines.

Highlights from QI's investor presentations in New York City earlier this month include an expectation for preliminary data from the ongoing Phase I/II FDA-authorized trial during 1Q10, which will include comparing medical imaging scans before treatment with QI's OFA cancer vaccine at 90-day intervals to monitor tumor size with the goal of achieving either stable disease or improvement (i.e. tumor shrinkage). Contingent on the initial results, QI expects to begin discussions with the FDA to expedite the start of a much larger pivotal (i.e. a study designed to obtain FDA approval) Phase 2b/3 clinical trial and is also working on R&D initiatives to improve and refine the OFA technology for the upcoming study such as isolating specific regions within OFA that elicit a targeted immune response against cancer cells.

Currently, QI has enrolled eight patients in the ongoing Phase I/II clinical trial, with a goal of completing the enrollment of all 27 patients by the end of 1Q10 (31-March) - at which time preliminary data is expected from the initial cohort of patients that are already enrolled in the study and receiving treatments. The study is open to women who have been diagnosed with Stage IV / Metastatic Breast Cancer and the treatment is free to eligible participants. While the inherent risks of developing an innovative therapeutic cancer vaccine cannot be eliminated, several key points make the risk / reward ratio favorable for early-stage investors in QI that accept the privately held status and speculative nature of such an investment.

1.) Because of their belief in QI, the Company's entire management and science team is working for either stock-based compensation only or at reduced salaries + stock compensation.

2.) QI originally filed with the FDA for authorization to conduct a Phase I safety trial with just three patients, but the Agency recommended a combination Phase I/II trial to expedite the clinical development process.

3.) QI is the exclusive licensee of various patent rights in the U.S., Europe and other countries for the use of OFA to diagnose, monitor, and treat multiple types of cancer. The OFA/iLRP patents are the by-product of 20 years and $30 million of research at The University of South Alabama Medical & Science Foundation and were primarily funded by the National Institute of Health's (NIH) National Cancer Institute (NCI). The collaboration announced with Auburn serves as a validation for QI's leadership and patent estate surrounding the OFA antigen, with more joint ventures and collaborations expected to follow.

4.) The market niche for a successful CI treatment approach for breast cancer is several billion dollars based on estimated pricing of $60,000 per treatment (consisting of three injections at monthly intervals) based on the following American Cancer Society statistics: (a) 2009 estimated U.S. deaths from breast cancer = 40,610; (b) 2007 estimated worldwide deaths from breast cancer = 464,854; (c) 2009 estimated new cases of breast cancer in U.S. = 194,280; and (d) estimated new breast cancer cases worldwide in 2007 = 1.3 million.

The ongoing Phase I/II study will include patient follow-up for a minimum follow-up period of two years and this will provide a steady flow of survival data while the Phase 2b/3 trial proceeds and progresses. In conjunction with FDA discussions to design the pivotal Phase 2b/3 study, QI will evaluate alternatives for its next phase of capital funding requirements that may include an initial public offering (IPO), reverse merger, joint venture (JV), or acquisition. Currently, QI has a fully diluted valuation of approximately $22 million with a single class of stock. Below is a summary of the current status for the lead therapeutic cancer vaccines in development for some other stocks included in the HavRx ImmunoTherapy / Vaccines Index .

In mid-November, Oncothyreon (NASDAQ: ONTY) reported its quarterly results and provided a development pipeline update. Stimuvax (BLP25 liposome vaccine, L-BLP25) is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, which is a glycoprotein antigen widely expressed on common cancers, including lung cancer, breast cancer, prostate cancer and colorectal cancer. ONTY's partner for the development of Stimuvax, Merck KGaA / Serono (OTC: MKGAY.PK), is actively enrolling patients in two global Phase 3 trials.

Initiated in February 2007, START is a randomized, double-blind, placebo-controlled study in patients with documented unresectable stage III non-small cell lung cancer who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. NCT00409188 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of December 2010 for final data collection of the primary outcome measure with an estimated enrollment of 1,322 patients.

STRIDE is a randomized, double-blind, placebo-controlled study in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer, initiated in June 2009 with a primary endpoint of progression-free survival (PFS). NCT00925548 is the ClinicalTrials.gov identifier for this study, which currently has an estimated date of September 2012 for final data collection of the primary outcome measure with an estimated enrollment of 909 patients.

Celldex Therapeutics (NASDAQ: CLDX) is developing CDX-110 (PF-04948568) along with Pfizer (NYSE: PFE) as a cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). CDX-110 is currently being evaluated in a Phase 2 study (ACT III) of CDX-110 in patients with newly diagnosed GBM. NCT00458601 is the ClinicalTrials.gov entry for this study (last updated on 11/20/09) and April 2010 is the estimated date for data collection for the primary outcome of progression-free survival status at 5.5 months from the date of first dose. The estimated study completion date is Nov 2010.

ImmunoCellular Therapeutics (IMUC.OB) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, therapeutic cancer stem cell vaccine (ICT-121) that targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months. ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. IND Filings for ICT?121 are expected for brain tumors in during 1Q10 while IND Filings for ICT?121 for pancreatic cancer are expected during 3Q10.

In late October, IMUC presented new data for its therapeutic cancer vaccine product candidate ICT-107 as an update to preliminary data that was presented at ASCO 2009 in late May and included a median PFS survival time (defined as the time between surgical tumor removal and tumor recurrence) in the 16 newly diagnosed patients enrolled in the trial was 19 months, which is over 12 months longer than the historical PFS of just 6.9 months. In addition, seven of the 16 patients continue to show no signs of tumor recurrence while three of the patients have gone more than two years without disease progression. ICT-107 targets six glioma-specific peptides, including targets that are highly expressed on cancer stem cells and IMUC expects to sign a licensing deal to fund further clinical development of ICT-107 during 2010.

In early October, Inovio Biomedical (AMEX: INO) announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered.

This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer. This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose.

The vaccine is delivered using Inovio's proprietary CELLECTRA intramuscular electroporation delivery device. Inovio expects to report interim data relating to safety and levels of immune responses (immunogenicity) from the second and third dose groups during 1H10 and plans to initiate a Phase 2 trial in late 2010.

Northwest Biotherapeutics (OTC: NWBO.OB) is developing DCVax-Brain as a personalized therapeutic cancer vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax-Brain is comprised of a patient's own dendritic cells that have been activated to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells. The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells in order to activate the patient's dendritic cells, which are subsequently injected back into the patient under the skin in the upper arm.

The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax-Brain an off-the-shelf product for that patient throughout the treatment period, following the initial collection, preparation, and manufacturing process. NCT00045968 is the ClinicalTrials.gov identifier for a Phase 2 study evaluating DCVax-Brain in GBM patients which currently has an estimated date of December 2011 for final data collection for the primary outcome measure. On 10/21/09, NWBO.OB reported that DCVax-Brain has begun a 240-patient Phase 2 clinical trial with 13 trial sites at medical centers across the U.S. and stated that the trial is not currently enrolling patients, but expects to resume doing so soon.

In late October, MannKind Corp. (NASDAQ: MNKD) announced that results of two Phase 1 studies demonstrate that the novel, investigational cancer vaccines MKC1106-MT and MKC1106-PP are well-tolerated and show encouraging immune response rates and objective tumor response in advanced melanoma, prostate cancer and other solid malignancies, setting the stage for Phase 2 studies.

MKC1106-MT is an active cancer immunotherapy product candidate consisting of three components, a DNA plasmid and two synthetic peptides, each of which is administered separately by the unique route of intranodal injection and together are designed to target two tumor-specific antigens that are commonly expressed by melanoma tumor cells. Findings reveal an immune response rate of greater than 40%, defined as the percentage of patients who showed elevated numbers of antigen specific T cells in the blood upon immunization, and preliminary evidence of clinical benefit. Of the 18 patients treated, 14 had visceral metastases and the remaining four had metastases confined to the lymphatic system.

MKC1106-PP is a similar agent that is designed to target two specific tumor antigens commonly expressed by various solid tumor cells. An immune response rate of 60% was observed and, of the 26 patients treated, seven patients achieved clinical responses defined as partial response (RECIST), change in PSA doubling time or stable disease for at least six months.

In late October, Antigenics (NASDAQ: AGEN) announced updated Phase 2 data for Oncophage (vitespen) for recurrent high grade glioma (brain cancer) for the first 20 patients treated, demonstrating a median survival of 10.1 months. Survival data continues to accrue on all patients in the study and thus far, six patients (30%) have survived at or beyond 12 months. The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma.

Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines and then receive four weekly doses of Oncophage and then bi-weekly doses thereafter in the absence of disease progression, unacceptable toxicity, or vaccine depletion. The Brain Tumor Research Center at the University of California, San Francisco (UCSF), has initiated an additional Phase 2 clinical trial of Oncophage in combination with the standard of care (radiation + Temodar) for newly diagnosed glioma patients to evaluate median overall survival, progression-free survival and immune response.

CEL-SCI Corp. (AMEX: CVM) is awaiting validation of its cold fill contract manufacturing facility (which will also manufacture Multikine) before initiating a pivotal Phase 3 clinical trial of Multikine. The pivotal Phase 3 study is designed as an open-label, randomized, global multi-center trial to evaluate the effects of Multikine plus standard of care (SOC) therapy (surgery + radiation or surgery + concurrent chemo / radiation) in subjects with advanced primary squamous cell carcinoma of the oral cavity versus the SOC therapy only.

The primary objective is to determine the efficacy of peri-tumoral and peri-lymphatic injection of Multikine given prior to SOC as measured by overall survival with secondary objectives that include evaluating the effects of Multikine on the cumulative incidence of local / regional control, progression-free survival, tumor response, tumor histopathology, and quality of life, and confirming safety of the treatment. About 800 patients are expected to be enrolled in the study on a global basis that includes North / South America, Europe, and Asia.

Click here to check out my kaChing.com virtual investing portfolio , strategy, long / short virtual stock picks, and statistics since I started using the site in mid-April. The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

Disclosure: Long CLDX, IMUC.OB, QI (privately held)

Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices. The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 3 billion prefilled syringes in use by 2012.

Below are some links to articles, reports, and presentations for Unilife, with more information available at the Company's ProActive News Room landing page .

Seeking Alpha Articles / Mike Havrilla

Unilife Medical (OTC: UNIFF.PK): Griffin Securities 8/19/09

Unilife Medical (OTC: UNIFF.PK): Sept. 2009 Presentation

Unilife Medical (OTC: UNIFF.PK): CCZ Equities 10/13/09

Unilife Medical (OTC: UNIFF.PK): Annual Report 10/30/09

More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000). Key differentiating features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes include the following:

1.) a passive needle retraction system that is activated inside the body

2.) healthcare providers / shot administrators control the speed of needle retraction

3.) auto-disabling prevents re-use or tampering with used syringes.

Disclosure: No positions.

The BioMedReports.com research download section has been updated to include PDFs for two recent research reports written by Griffin Securities for Clinical Data (NASDAQ: CLDA) and Lpath, Inc. (OTC: LPTN.OB). Lpath received a buy rating with a $5 per share 12-month price target while CLDA was rated a buy with a 12-month price target of $38 per share. Below is a summary of both companies from their respective reports.

Lpath, Inc. is a biotechnology company focused on lipidomics-based therapeutics that target bioactive signaling lipids for treating a wide range of human disease and is the only company to have developed monoclonal antibodies against bioactive lipids. The Company is currently advancing three early-stage (poised to enter Phase 2 clinical studies) drug candidates (ASONEP ^TM ; iSONEP ^TM ; and Lpathomab ^TM ) in addition to a drug-discovery platform known as ImmuneY2 ^TM which Lpath is leveraging to further expand its pipeline.

In early June, Clinical Data announced positive top-line results from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the FDA for vilazodone for the treatment of MDD during 1Q10.

CLDA is also evaluating Stedivaze (apadenoson) in an ongoing Phase 3 clinical trial as a cardiac stress imaging agent. Stedivaze is used to identify the symptoms of coronary artery disease (CAD) with patent protection through 2027 and estimated peak sales potential of $523 million. On 11/18/09, CLDA announced the start of the Phase 3 trial of Stedivaze, which is a selective A2A receptor agonist, in development for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) scans (aka cardiac stress tests), which are used to identify symptoms of CAD.

Stedivaze is a highly selective, high affinity agonist of the adenosine A2A receptor. The initiation of the trial followed a meeting with the FDA that reviewed Phase 2 data showing a rapid onset and offset of action following bolus dosing and improved tolerability over marketed products, such as Adenoscan (adenosine) by Astellas Pharma. The trial is expected to enroll approximately 750 patients over an 18-24 month period with an estimated date of 11/30/11 to complete this process.

The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

Disclosure: No positions.

Advantages of the Epinex Quantitative Immunoassay System for Point-of-Care Testing include the following:

1.) Rapid:  Results within minutes.

2.) Quantitative:  Yields a precise value, not just "yes" or "no".

3.) Easy to use:  No training required.

4.) Cost effective:  Point-of-care testing reduces overall cost to the healthcare system.

5.) High Sensitivity:  Results comparable to the "gold standard" ELISA test.

The Epinex G1A ^TM (glycated albumin, which is a measure of average blood sugar control over the previous month) Test is the first of a series of diagnostic monitoring tests based on the Company's proprietary detection platform technology and dual-mode test reader. Future rapid tests under development by Epinex include infectious diseases, other metabolic disorders, coronary artery disease, rheumatoid arthritis, Down Syndrome, and neonatal HIV.

Albumin is a protein found in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation.

The Epinex G1A ^TM Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A ^TM reader and a proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on the Company's platform technology, the G1A ^TM reader automatically quantifies the analyte concentrations on the cassette and gives the G1A ^TM Index, the ratio of glycated albumin to total albumin in serum.

The G1A ^TM Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A ^TM test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor's office or other central data location.

The global diabetes epidemic affects an estimated 300 million people worldwide and this number is expected to double by 2030 with an estimated cost of $232 billion. Diabetes is the fifth leading cause of death in the U.S. and fourth leading cause of death on a global basis. Complications of diabetes may include heart disease, blindness, kidney failure, extremity amputations / circulation problems, and neuropathies.

The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market is dominated by global, diversified healthcare giants such as Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Roche (OTC: RHHBY.PK) (Accu-Chek), and Bayer (OTC: BAYRY.PK) (Ascenscia).

Glycation (binding of excess sugar to proteins such as albumin and hemoglobin) is a major cause of the long-term complications of diabetes and an indicator of the risk of developing those complications. The goal of diabetes monitoring is to control glycation and to avoid the complications of diabetes. This allows diabetics and their health care providers to determine a treatment regimen, to monitor its effectiveness, and to alter it as needed for better overall glucose control. Current diabetes monitoring methods may include periodic doctor visits (e.g. every six months) in addition to multiple tests for monitoring blood sugar levels.

Blood glucose monitoring is the most common and frequent means of measuring blood sugar levels on a real-time basis and may be conducted up to four times daily or more via finger prick or alternate site (e.g. forearm) testing by patients. While blood glucose machines are often subsidized or given away free, the test strips are expensive and represent an ongoing cost along with poor patient compliance due to the high frequency of testing and finger pricks that are involved with this method. Glycated hemoglobin (HbA1c) is typically conducted 2-3 times per year and provides a measure of average blood sugar control over the previous 90 days.

Disclosure: No positions 

Advantages of the Epinex Quantitative Immunoassay System for Point-of-Care Testing include the following:

1.) Rapid:  Results within minutes.

2.) Quantitative:  Yields a precise value, not just "yes" or "no".

3.) Easy to use:  No training required.

4.) Cost effective:  Point-of-care testing reduces overall cost to the healthcare system.

5.) High Sensitivity:  Results comparable to the "gold standard" ELISA test.

The Epinex G1A ^TM (glycated albumin, which is a measure of average blood sugar control over the previous month) Test is the first of a series of diagnostic monitoring tests based on the Company's proprietary detection platform technology and dual-mode test reader. Future rapid tests under development by Epinex include infectious diseases, other metabolic disorders, coronary artery disease, rheumatoid arthritis, Down Syndrome, and neonatal HIV.

Albumin is a protein found in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation.

The Epinex G1A ^TM Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A ^TM reader and a proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on the Company's platform technology, the G1A ^TM reader automatically quantifies the analyte concentrations on the cassette and gives the G1A ^TM Index, the ratio of glycated albumin to total albumin in serum.

The G1A ^TM Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A ^TM test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor's office or other central data location.

The global diabetes epidemic affects an estimated 300 million people worldwide and this number is expected to double by 2030 with an estimated cost of $232 billion. Diabetes is the fifth leading cause of death in the U.S. and fourth leading cause of death on a global basis. Complications of diabetes may include heart disease, blindness, kidney failure, extremity amputations / circulation problems, and neuropathies.

The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market is dominated by global, diversified healthcare giants such as Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Roche (OTC: RHHBY.PK) (Accu-Chek), and Bayer (OTC: BAYRY.PK) (Ascenscia).

Glycation (binding of excess sugar to proteins such as albumin and hemoglobin) is a major cause of the long-term complications of diabetes and an indicator of the risk of developing those complications. The goal of diabetes monitoring is to control glycation and to avoid the complications of diabetes. This allows diabetics and their health care providers to determine a treatment regimen, to monitor its effectiveness, and to alter it as needed for better overall glucose control. Current diabetes monitoring methods may include periodic doctor visits (e.g. every six months) in addition to multiple tests for monitoring blood sugar levels.

Blood glucose monitoring is the most common and frequent means of measuring blood sugar levels on a real-time basis and may be conducted up to four times daily or more via finger prick or alternate site (e.g. forearm) testing by patients. While blood glucose machines are often subsidized or given away free, the test strips are expensive and represent an ongoing cost along with poor patient compliance due to the high frequency of testing and finger pricks that are involved with this method. Glycated hemoglobin (HbA1c) is typically conducted 2-3 times per year and provides a measure of average blood sugar control over the previous 90 days.

Disclosure: No positions