The United Kingdom's National Institute for Health and Clinical Excellence (NICE) has recently begun the draft scope for the official Health Technology Appraisal of Generex's (GNBT) novel buccal insulin for the management of type 1 diabetes. Oral-lyn is not yet licensed for sale in the UK. Oral-lyn is in Phase III trials for patients with Type 1 diabetes and Generex is consequently moving closer towards submission to the Medicines and Healthcare products Regulatory Agency MHRA. At present, over 350 patients have been enrolled in the Phase III program at 70 clinical sites around the world.

NICE produces guidance on public health, health technologies and clinical practice for England, Wales, Northern Ireland and Scotland. These are recommendations, based on the best available evidence, on the appropriate treatment and care of people with specific diseases and conditions. NICE does not license drugs or devices. Licensing drugs and devices in the UK is done by MHRA. A recommendation by NICE ends any uncertainty and inequality about prescribing. Once national guidance has been issued by NICE, it replaces local recommendations.

This year's San Antonio Breast Cancer Symposium contained many studies that pertain to HER2/neu treatment. Current treatment revolves around Genentech's (DNA) Herceptin, but the event brings together many researchers who present their findings and a glimpse of improved future HER2/nue cancer treatment options. Large pharma, as always, dominates the scene, but it always appears to be the smallest of biotechs that present the most promising pipeline developments. Groundbreaking science is not always successful in the end, but it is possible that this prestigious event has brought evidence of the advances that may pave the way to an improved future of HER2/neu cancer treatment.

The current treatment option for a small percentage of HER2/neu patients is Herceptin, which costs about seventy thousand US dollars for a full course of treatment. In the fourth quarter of 2007, Herceptin brought in $327 million in revenue for Genentech. However, there is a wide group of breast cancer patients with low levels of HER2 expression that do not benefit from Herceptin treatment. However, researchers from the United States Military Cancer Institute are developing peptide based vaccines that may be available to a much wider spectrum of breast cancer patients with a dosing regimen that causes much less toxicity.

The American Association of Diabetes Educators [AADE] released results last week at its high profile 35th Annual Meeting from an innovative new survey entitled the "Injection Impact Report".

The report highlights the level of communication between patients and healthcare providers relating to insulin injections and also spotlights how those injections can impact patients' daily lives and treatment adherence. Conducted online between June 12 and July 7, 2008, the report surveyed 502 people with diabetes who inject insulin using either a syringe or a pen and also queried over 300 healthcare professionals who treat them. The report has gained the attention of the diabetic community, although the results were expected by many who are familiar with the burden associated with daily injections of insulin.

The United States Military Cancer Institute has been investigating peptide based vaccines for therapuetic value in the war against breast cancer. Previous attempts at developing peptide vaccines for breast cancer had been largely disappointing. However, those vaccines were designed to treat metastatic disease.

In contrast, the USMCI researchers, based at Walter Reed Army Medical Center, have been investigating novel peptide vaccines as a preventive therapy for patients who have been treated for breast cancer and have a high risk of recurrence. In particular, the researchers have focused their efforts on two impressive peptide vaccines.

The American Diabetes Association's 68th Scientific Sessions kicked off in San Francisco on June 6th and ends June 10th. Large pharma dominates the exhibition and use the venue to present their latest study results in an effort to orientate health care professionals on the products they may be prescribing as well as the investment community on the potential value hidden in their pipelines. It was at last year's ADA event, held in Chicago, where all attention centered on GlaxoSmithKline's (GSK) Type 2 oral pill Avandia. First-quarter sales of Avandia declined 56 percent after it was linked to an increased risk of heart attacks while revenue from insulin is climbing fast.

A novel theme has emerged at this year's event emphasizing the merits of earlier insulin therapy in Type 2 patients in the wake of this tumultuous year for oral pills. Two of the largest pharmaceutical companies have brought data to support initiating insulin treatment earlier which is in contrast to previous medical practice. If this trend continues, the future benefactors may not only include the current leaders of injectable insulin such as Novo Nordisk (NVO), Eli Lilly (LLY) and Sanofi-Aventis (SNY), but also Generex Biotechnology (GNBT) and their Oral-lyn Buccal spray. Oral-lyn is a liquid based spray where the insulin delivery occurs in the inner cheek wall with no deposition into the lungs, and is still standing strong after the collapse of Pfizer's (PFE) Inhalable Exubera led to the discontinuation of the inhalable efforts of Eli Lilly, Novo Nordisk and have placed considerable doubt on the future success of Mannkind's (MNKD) Inhalable Technosphere Insulin.

Generex Biotechnology (GNBT) quietly released an 8K SEC filing on May 1st. In this "Current Report" they note:

Generex Biotechnology Corporation (the "Company") has received Special Access Programme authorization from the Therapeutic Products Directorate of Health Canada for a patient-specific, physician-supervised treatment of Type-1 Diabetes Mellitus with Generex Oral-lyn™, the Company's proprietary oral insulin spray product. Health Canada's Special Access Programme [SAP] provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

In the April issue of Diabetes Care, the long running "Atherosclerosis Risk in Communities" [ARIC] study led by Frederick Brancati, M.D., of Johns Hopkins, found that lung function declines faster in type 2 diabetes patients than in those without the disease. Dr. Brancati and his colleagues also said that there may also be implications for the use of inhaled forms of insulin.

The American Diabetes Association, which publishes Diabetes Care, issued a press release titled "Reduced Lung Capacity Accelerates with Diabetes Makers of Inhaled Insulin Should Take Note, Researchers Say". They warn in their article that

Insulin was discovered in Toronto in 1921 and arrived on the market in 1922. Since that time there have been episodic attempts to escape the inevitability of injection.

The race for developing a successful needle-less insulin delivery system has taken some recent nasty turns as the inhalable efforts of large pharma companies have all come to an end. The latest news that Pfizer (PFE) is adding a new warning label to Exubera regarding instances of lung cancer in clinical trials may prove to be the final nail in the coffin for hopes of any inhalable insulin winning the hearts and minds of needle suffering diabetics.