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Pulmo BioTech Inc. (OTC Bulletin Board: PLMO.OB) has announced details of the methodology and purpose of its Phase I Human Trials with its PulmoBind Molecular Imaging technology for the diagnosis of Pulmonary Embolism and Pulmonary Hypertension.

The work will be carried out by the Pulmo BioTech subsidiary, PulmoScience Inc., and the title of the work is: “Phase I Study of the Use of PulmoBind for Molecular Imaging of the Pulmonary Circulation.”

The study will be a single center, Phase 1 safety and efficacy study of a single intravenous injection of PulmoBind in human subjects with no history of lung disease.

The Outcomes will be:

1. Safety — to determine pharmacokinetics and biodistribution of PulmoBind in humans and to perform dosimetric evaluation

2. Efficacy — to evaluate the ability of PulmoBind to allow lung perfusion imaging in humans

Pulmo BioTech expects this work to be completed by late summer 2008.

About Pulmo BioTech Inc.

Pulmo BioTech Inc. specializes in the development and marketing of medical technology and research. Our proven strengths combine extensive commercial experience and academic credentials. The principal staff members are acknowledged experts in their specialized fields, and work with a broad range of investment institutions. Pulmo BioTech’s mission is to utilize scientific imagination and drive, together with managerial and financial acumen, to bring innovative and profitable products to the marketplace to the benefit of all stock holders.

About PulmoScience Inc.

PulmoScience Inc. was established in 2006, and is currently developing a non-invasive Molecular Imaging technique for the diagnosis of Pulmonary Embolism, Pulmonary Hypertension and Lung Inflammatory diseases under the trade name PulmoBind.

The company was conceived within the Montreal Heart Institute “MHI” (a world renowned hospital and educational facility). Jointly owned by MHI subsidiary Innovacor as the technical and operational partner, Dr. Jocelyn Dupuis (the scientific director and originator of the PulmoBind Molecular Imaging technology), and by Pulmo BioTech Inc. as the funding partner, PulmoScience Inc. aims to develop this unique and exciting technology, to fund necessary trials, and to bring the products to market.

PulmoScience believes that the market for its product candidates is worth in excess of $500 million per annum and that, provided Regulatory Approval is achieved, the safety and efficacy of its products could allow it to dominate that market.

About PulmoBind

PulmoBind uses an intravenously delivered radionuclide tagged molecule which specifically bonds to the inner walls of the circulatory system in the lungs, and by the use of an external Gamma Camera allows an image of the integrity of the blood vessels throughout the lungs to be seen by a diagnostic clinician. PulmoScience is currently undertaking Regulatory Approval for Phase I Human Trials, and while subsequent results from additional tests might not corroborate the current results, PulmoScience believes that PulmoBind has the potential to dominate the market for the diagnosis of Pulmonary Embolism. In particular, this belief is driven by PulmoScience’s expectations of the improved safety and efficacy that PulmoBind will offer when compared to the current incumbent nuclear medicine based technology for the diagnosis of Pulmonary Embolism. In addition, early indications are that PulmoBind could be highly effective in the early stage diagnosis of Pulmonary Hypertension, a condition for which there is no current front line diagnostic test.

Forward Looking Statements

Forward-looking statements contained in this and other written and oral reports are made based on known events and circumstances at the time of release, and as such, are subject in the future to unforeseen uncertainties and risks. All statements regarding future performance, earnings projections, regulatory approval, events or developments are forward-looking statements. It is possible that the future performance of the company may differ materially from current expectations, depending on economic conditions and the uncertainty of regulatory approval. A change in economic conditions may have a particularly volatile effect on results. Among the other factors which may affect future performance are: competitive market conditions and resulting effects on sales and pricing; increases in raw-material costs that cannot be recovered in product pricing; and global economic factors, including difficulties entering new markets and general economic conditions such as inflation, interest rates and credit availability. The company makes these statements as of the date of this disclosure, and undertakes no obligation to update them.

Pulmo BioTech Inc.
http://www.pulmobiotech.com

Health Matters: Human Clinical Trials

There is a popular debate over the value and safety of human clinical trials, research studies that analyze medical information gathered from patient volunteers . Joe Ramsdell, M.D., UCSD School of Medicine, explains the role of the clinical trial in modern medicine. Series: “Health Matters” [2/2002] [Health and Medicine] [Show ID: 6096]

Complexities of Clinical Trials (34 minutes)

Courtesy of the Transverse Myelitis Association - http://www.myelitis.org/rnds2004/

2004 Rare Neuroimmunologic Disorders Symposium

Lecture by J. McArthur, MBBS, MPH

Scientists at The Australian National University are a step closer to understanding the rare Hartnup disorder after discovering a surprising link between blood pressure regulation and nutrition that could also help to shed light on intestinal and kidney function.

The team from the University’s School of Biochemistry and Molecular Biology together with colleagues from the University of Sydney set out to study nutrient uptake in the intestine and discovered an essential role of a protein called ACE2 in the process. ACE proteins cut off a small part of a precursor molecule generating a hormone, which regulates blood pressure. ACE inhibitors are widely prescribed drugs that reduce the risk of heart failure and protect against the long-term effects of diabetes.

Two versions of the protein are known as ACE1 and ACE2. ACE1 is targeted by the blood pressure reducing drugs, but until now the role of ACE2 has been less clear. What the researchers found was a completely different role for ACE2 in nutrition.

“Protein forms up to 20 per cent of our nutrition,” said one of the authors of the report, Professor Stefan Bröer. “Before it can be used by the human body, protein is split into its subunits called amino acids. The amino acids are then removed from the intestine by specialised cells which are endowed with a large number of transporters moving nutrients from the intestine into cell.

“Instead of tailoring a specific hormone, ACE2 cuts into proteins releasing amino acids from the intestine into cells. Additionally, we found that ACE2 was also important to endow the cell with transporters” he said.

The research shows that a failure of certain transporters to make contact with ACE2 can cause Hartnup disorder - where amino acid absorption in the intestine is impaired resulting in neurological problems and a skin rash in children.

The paper, published in The Federation of American Societies for Experimental Biology (FASEB) Journal, also highlights the variety of roles that proteins can play.

“The results demonstrate a connection between blood pressure regulation and nutrition and also show that proteins in the body can serve several functions. This explains why drugs can have surprising side effects if the target carries out several functions.

“The results of this study will help understanding intestinal and kidney function, which are affected in common disorders such as diabetes and celiac disorder,” said Professor Bröer.

Source: Martyn Pearce
Research Australia

Can a blood test improve treatment outcomes for colorectal cancer patients? Recently published studies indicate that personalized chemotherapy dose management — measuring drug levels in patients’ blood and adjusting them for optimal dosing — can substantially reduce severe toxicity and improve efficacy in colorectal cancer.A Phase III randomized study of 208 colorectal cancer patients, by Erick Gamelin, M.D., Ph.D. et. al., was published in the May 1 issue of the Journal of Clinical Oncology (JCO). It found that metastatic colorectal cancer patients whose dose of 5-fluorouracil (5-FU) was personalized based on results of regular blood tests experienced reduced severe toxicities and nearly doubled response rates compared to patients who received standard 5-FU dosing based on body surface area. Additionally, patients who received personalized dosing experienced a 48 percent relative improvement in survival at two years. 5-FU is the cornerstone chemotherapy in most treatment regimens for this type of cancer.

The current standard-of-care in dosing 5-FU is based on body surface area (BSA) and is calculated using patients’ height and weight. In the JCO study, personalized dosing was based on blood tests to measure the actual level of the drug. The study demonstrated that only 25 percent of colorectal cancer patients achieved optimal chemotherapy blood levels when dosed by BSA. Seventeen percent of the BSA-dosed patients received toxic levels of the drug, while 58 percent were under-dosed.

The JCO study, “Individual 5-fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: Results of a multicenter randomized trial of patients with metastatic colorectal cancer,” evaluated patients being treated with 5-FU in combination with leucovorin. Half of the patients were dosed with 5-FU based on BSA. The other half were initially dosed based on BSA, with subsequent cycle doses adjusted based on blood tests that measured the actual concentration of chemotherapy in the patients’ blood plasma. The primary endpoint was tumor response; the secondary endpoint was treatment tolerance.

The JCO study concluded that:

– Response rates were nearly doubled in the dose adjusted group versus the BSA group (33.6 percent versus 18.3 percent) with statistical significance

– Overall survival at two years among patients with personalized 5-FU dose management improved by 48 percent with an improved median survival of 22 months versus 16 months in the BSA arm. The survival data was leaning towards significance

– Grade III/IV 5-FU related toxicities were found to be significantly lower in patients with personalized dose adjustment

– 58 percent of patients were found to be under-dosed (sub-therapeutic and less effective drug levels) and had their doses adjusted upwards

– 17 percent were found to be over-dosed (increasing the risk of severe side effects) and had their doses adjusted downward

Dr. Gamelin, director of the Paul Papin Cancer Center in Angers, France, stated, “Pharmacokinetically-guided or personalized 5-FU dose management is the standard-of-care at our cancer center. We routinely test the level of 5-FU in the blood of our colorectal cancer patients and adjust their doses to achieve optimal drug concentration. Clinical studies conducted over the past 20 years have demonstrated that there is significant variability in 5-FU blood levels when patients are dosed by BSA, the prevailing practice.”

“Our Phase III study demonstrates that the majority of patients are either over-dosed or in most cases, under-dosed. Personalized 5-FU dosing allows us to substantially reduce severe toxicity while improving patient quality of life and treatment outcomes,” said Dr. Gamelin.

The value of personalized 5-FU dose management was also reinforced in two studies reported earlier this year at the American Society of Clinical Oncology (ASCO) Gastrointestinal Symposium. Results from these Phase II studies of metastatic colorectal cancer patients treated with 5-FU (in combination regimens commonly used in the U.S., FOLFOX and FOLFIRI) demonstrated improved response rates and reduced toxicities with blood level dose management.(1)

New, Multicenter Study Seeks to Use Faster, Less Expensive Blood Test

To date, analysis of 5-FU patient blood concentrations could only be performed by complex, labor-intensive methods, such as liquid chromatography-mass spectroscopy (LC-MS). Saladax Biomedical, Inc., a Bethlehem, Pa.-based biotech company, is sponsoring a soon-to-enroll study to support the case for blood-based 5-FU dose management with the FOLFOX regimen. The study will employ a new immunoassay based on a patented technology from Saladax. The assay, called Personalized Chemotherapy Management (PCM), provides LC-MS-like performance but is easier to use and less expensive.

The multicenter, randomized Phase III study will enroll more than 200 patients with metastatic colorectal cancer to determine the efficacy of 5-FU dose management utilizing the PCM test. Edward Chu, M.D., chief of Medical Oncology and deputy director of the Yale Cancer Center in New Haven, Conn., will be the lead investigator of the study, which will involve several other cancer centers in the U.S., as well as the Paul Papin Cancer Center in France.

“Therapeutic dose management is common for many important drugs in other areas of medicine. Based upon recent evidence that we can lower toxicity and improve efficacy with personalized 5-FU dose management, it makes sense to use this same approach in cancer treatment,” said Dr. Chu. “We hope that this study will provide oncologists with important evidence and guidance on the role of drug monitoring in their routine practice,” he added.

About Colorectal Cancer

Colorectal cancer is a worldwide public health problem, with more than 940,000 new cases diagnosed each year, resulting in approximately 500,000 deaths.(2) In the U.S., it is the third leading cause of cancer mortality, and in 2008, nearly 50,000 deaths will be attributed to this disease.(3) Its incidence rate is strongly correlated with age. Data from industrialized countries demonstrate that the incidence of colorectal cancer rises three-fold between the ages of 60 and 80 years.(4)

About Saladax

Saladax Biomedical is pioneering the development of novel, fast, and inexpensive immunoassays that will enable routine blood-level monitoring of anti-cancer drugs to become the standard-of-care in treating cancer patients. With Personalized Chemotherapy Management (PCM), oncologists will be able to adjust the administered dose based on each patient’s individual drug level, leading to reduced toxicity, improved outcome and lower cancer care costs. Saladax is headquartered at the business incubator of the Ben Franklin Technology Partners (BFTP) of Northeastern Pennsylvania on the campus of Lehigh University in Bethlehem. The 5-FU PCM test will be available to U.S. clinicians later this year through a major reference laboratory.

References

(1) Proceedings from the American Society of Clinical Oncology - GI, January 2008; Orlando, FL Abstract #429 & Abstract #431

(2) World Health Organization, “World Cancer Report.” April 3, 2003, http://www.who.int/mediacentre/news/releases/2003/pr27/en/(April 22, 2008).

(3) American Cancer Society, “What are the Key Statistics for Colorectal Cancer?,” March 5, 2008, http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_colon_and_rectum_cancer.asp (April 22, 2008).

(4) Gamelin, E, Delva, R, Jacob, J, et al: “Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: Results of a multicenter randomized trial of patients with metastatic colorectal cancer.” J. Clin Oncol 13:2099- 2105, 2008.

(5) Saladax Biomedical
http://www.saladax.com

A Paradigm Shift in Pharmaceutical Clinical Trials - (6 minutes)

Taren Grom, Editor of PharmaVOICE magazine talks with Ira Spector, Vice Chief of Clinical Operations at Wyeth, about improving clinical tria…all » Taren Grom, Editor of PharmaVOICE magazine talks with Ira Spector, Vice Chief of Clinical Operations at Wyeth, about improving clinical trials in the pharmaceutical industry. Part of the PharmaVOICE Webcast Network.