Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, has received approval from the New England Institutional Review Board (IRB) to enroll the first patient in a Phase II clinical trial of cervical dysplasia (cervical intraepithelial neoplasia or CIN).

The study will be a blinded, randomized comparison of ADXS11-001 versus placebo for the treatment of cervical dysplasia.

About the Phase II Clinical Trial

In this Phase II clinical trial, patients will receive three (3) administrations of ADXS11-001 at monthly intervals. Six (6) months after receiving their first dose, they will receive the standard of care for the treatment of their disease, which is surgery. Efficacy will be determined by comparing pre-treatment biopsy samples with surgical tissue samples. General observations to be made in the trial include that of patients’ health and well being, progression and state of disease, and clinical immunology.

The experimental protocol calls for thirty (30) patients in each group to be treated, for a total of one hundred, twenty (120) patients. ADXS11-001 dosage groups include two (2) doses that are lower than previously administered (5.0 x107 and 3.3 x108 cfu) and one at the lowest dose administered in Phase I (1.0×109 cfu).

About the New England IRB

New England IRB is an independent institutional review board for sponsors, CROs and individual researchers across the U.S. Its priority is to ensure safety of human subjects in clinical trials and we are committed to an ethical and thorough review process. Its Boards are comprised of highly qualified members with significant experience and knowledge in the ethical, scientific and legal aspects of clinical trials.

Founded in 1988 New England IRB was one of the first central IRBs established to meet the ethical review needs of the clinical trials industry. For studies ranging from one site to several thousand, NEIRB is focused on the protection of human subjects, responsiveness and service.

New England IRB has been audited by the U. S. Food and Drug Administration (FDA) and found to be in compliance with regulations.

Source
Advaxis

Stryker Corp.’s biotech division and four current and former executives have been indicted on federal fraud charges related to their marketing of medical devices used in spinal and long bone surgeries.

According to the indictment obtained in U.S. District Court in Massachusetts, Stryker Biotech, LLC, and the executives promoted the firm’s OP-1 Implant and OP-1 Putty, which stimulate growth in long bones, for unapproved uses.

The devices had been approved by the FDA, but only under a “highly restrictive Humanitarian Device Exemption,” according to a statement from the acting U.S. attorney in Boston, Michael K. Loucks.

“One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the U.S. and could not be sold for a profit,” according to Loucks.

The indictment alleged that Stryker and the individual defendants promoted the products much more broadly.

In particular, according to Loucks, they told doctors that the OP-1 products could be combined with a bone void filler, called Calstrux. The company and its executives also provided “recipes” to surgeons, medical technicians, and others as to how to mix the OP-1 products with Calstrux.

“It is alleged that some of these untested ‘recipes’ called for medical personnel to mold the combined product into ‘cigars,’ ‘Tootsie Rolls,’ or ‘Vienna sausages,’” Loucks said.

The indictment charges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA.

It also alleges that the defendants promoted these product combinations because they knew that, without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products.

According to Loucks, “serious medical problems arose in a number of patients from this untested mix of products.”

Stryker and the individual defendants were also charged with making false statements to the FDA about the number of patients treated with the OP-1 Putty.

Specific charges include wire fraud, conspiracy, misbranding, and making false statements.

Named as defendants were Stryker Biotech, based in Hopkinton, Mass.; its former president, Mark Philip; and current sales managers William Heppner, David Ard, and Jeff Whitaker.

Conviction could lead to fines for Stryker of at least $500,000 for each count, as well as exclusion from federal and state healthcare programs.

The individual defendants could face up to 30 years in prison and fines of $750,000 or more if convicted.

A statement issued by Stryker said the firm was “disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter.”

It said the company would have no further comment on the allegations.

Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group, announced that its partner Roche has disclosed the results of a first phase III clinical study using Taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s Research. Results from Roche’s Phase III study T-EMERGE 2 met its primary endpoint of change in HbA1c (subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to metformin, a thiazolidinedione [TZD], or metformin and a TZD). A superiority versus exenatide was demonstrated.

This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. GLP-1 analogues, which stimulate insulin secretion and suppress diabetes field.

The results showed that taspoglutide demonstrated superior HbA1c reduction versus exenatide following 24 weeks of treatment. The study analysis included 1,189 patients, equally randomized into three active arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks, and exenatide 10 mcg twice daily). Taspoglutide was generally well tolerated. The most frequently reported adverse events among taspoglutide and exenatide treated patients were nausea and vomiting.

About T- EMERGE 2

T-EMERGE 2 is an open-label, 24-week core study, to demonstrate non-inferiority (with a pre-specified test for superiority) versus twice-daily exenatide, involving 1189 patients, equally randomized into three active arms (taspoglutide at doses of 10 and 20-mg, and exenatide 10 mcg). All patients continue into long-term extension of the study.

About the T-EMERGE Program

Roche’s T-EMERGE Phase III clinical trial programme is designed as multicenter, multi-country, randomized, controlled (active or placebo), double-blind and open studies. Over 6000 patients will be enrolled in the eight studies that comprise the T-EMERGE programme. Studies include two parallel taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.

About Taspoglutide (R1583)

Taspoglutide was selected from a family of human once-weekly long-acting glucagon-like peptide-1 (GLP-1) analogues with structural modifications which confer intrinsic controlled release properties. Ipsen is the originator of the concept of matrix free sustained release formulation applied to therapeutic peptides and proteins. Taspoglutide is being developed as a novel and innovative treatment for patients with type 2 diabetes mellitus, the fourth leading cause of death in most developed countries. The structure of the molecule is similar to that of the natural human hormone GLP-1, and has the potential for intervals of up to two weeks in between administration without the use of a matrix

About Diabetes

Diabetes is a disease characterized by excess blood glucose due to a deficiency in insulin availability and/or resistance to its action. Type 2 diabetes accounts for 90% to 95% of all diabetes cases worldwide and occurs almost entirely in adults. Complications from diabetes, such as coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness, are resulting in increasing disability, reduced life expectancy and enormous health cost for virtually every society. According to current estimates by the World Health Organization, the number of people with diabetes is set to more than double in the next 20 years to over 300 million by the year 2025.

About the agreement

Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market Taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen retained co-marketing rights.

Source
Ipsen

View drug information on Glucagon.