The Journal of Clinical Oncology (DOI: 10.1200/JCO.2008.20.2515) releases an article covering Active Biotech’s (NASDAQ OMX Nordic: ACTI) cancer project ANYARA, where ANYARA was studied both as a single agent and in combination with an established tumor therapy - docetaxel (Taxotere®) - in patients with advanced cancer.

Two parallel Phase I studies1) were performed, one monotherapy study (including 39 patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) or renal cell cancer (RCC)) with ANYARA and one study in combination with docetaxel (13 patients with NSCLC), in order to assess the safety, tolerability and pharmacology of ANYARA.

The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel.

ANYARA showed immunological activity including systemic increase in inflammatory cytokines, selective expansion of ANYARA reactive T-cells and induction of tumor infiltrating T-cells. Anti-tumor activity was assessed and in the mono study fourteen patients (36%) had Stable Disease (SD) after two months. In the combo study the best overall response was confirmed Partial Response (a tumor reduction of at least 30 percent), for 2 patients (15%) and SD for 5 patients (38%).

ANYARA is presently in development primarily for the treatment of renal cell cancer. A pivotal phase III study, which has completed enrollment of over 500 patients, is currently ongoing.

Active Biotech AB (publ)

Tomas Leanderson
President & CEO

1) Previously presented in summary in press releases: December 13, 2006 “Active Biotech’s Novel Cancer Treatment ANYARA Shows Pharmacological Proof of Concept after Successful Phase I Studies” and October 24, 2007 “Active Biotech’s Cancer Project ANYARA Proven Safe in Combination with Taxotere®”, now detailed in JCO.

About ANYARA

ANYARA is a TTS (Tumor Targeting Superantigens) compound that makes the treatment of cancer tumor-specific. The development of ANYARA is mainly focused on renal cell cancer. Positive data was reported in connection with the interim analysis in Phase II/III and from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. The median survival of 26.2 months observed for patients with advanced renal cancer and treated with ANYARA is twice the expected length. ANYARA has been granted orphan-drug status by the EMEA for the indication renal cancer. Information concerning the ongoing clinical trial is available at http://www.activebiotech.com and http://www.clinicaltrials.gov.

Source
Active Biotech

View drug information on Taxotere.

Canadian scientists at the University of Alberta’s Cross Cancer Institute are developing a new technology that integrates two existing medical devices — medical linear accelerators, or “linacs,” which produce powerful X-rays for treating cancer, and magnetic resonance imagers (MRIs), which are widely used to image tumors in the human body.

The proposed hybrid Linac-MR system promises to help doctors treat certain types of cancer by allowing them to accurately monitor moving tumors in people’s lungs and other soft tissues such as the liver or prostate in real time while the radiation treatment is ongoing. Though the new technology is not yet available in the clinic, the Canadian scientists have now demonstrated its feasibility for the near future.

In related research, a group from Stanford University is determining the specifications for how the new technology can be used. Both groups will discuss their latest findings at the 51st meeting of the American Association of Physicists in Medicine (AAPM), which takes place from July 26 - 30, 2009 in Anaheim, California.

The success of modern cancer radiotherapy often depends on how well radiation oncologists and medical physicists can determine the exact location and shape of a tumor. When doctors plan radiotherapy treatment for their patients, they will first define the outline of target tumors by collecting high-resolution 3-D images. The better they define the outline of a tumor, the more precisely they can irradiate it, and the more successfully they can kill the cancerous cells inside while sparing the surrounding healthy tissue.

Imaging techniques have improved to the point that doctors can now define the edges of many tumors to within a fraction of an inch. During treatment, however, many tumors will move. Tumors in the lungs, for instance, can move up to an inch or more as a person breathes, complicating treatment. Therefore, traditionally, radiation is delivered to a slightly larger area surrounding the tumor to ensure that the tumor is always in the beam’s sight. This means, however, that adjacent normal tissue as well as critical organs such as the heart and spinal cord may receive harmful radiation dose.

In recent years, image-guided radiation treatment (IGRT) has emerged as a technique for following tumors as they move. In IGRT, doctors typically use implanted markers to localize the tumor or x-rays to generate computed tomography (CT) images of the patient just prior to treatment to determine the tumor position on that day and adjust the patient position to place the tumor to coincide with the high radiation dose.

According to B. Gino Fallone, the director of Medical Physics at the University of Alberta’s Cross Cancer Institute, image-guided radiotherapy is simply the latest sophisticated way of doing what radiologists have always done. “Track it and treat it,” he says. “That’s been the goal of radiation oncology for 50 years.”

While existing IGRT techniques are effective, they are limited because they do not give true image-based guidance of the entire volume of the tumor, says Amit Sawant, an instructor in the Department of Radiation Oncology at Stanford University. Instead of imaging the whole anatomic volume containing the tumor, markers and seeds simply provide a few points in space that doctors can follow — something Sawant refers to as “faith-based radiation delivery.”

While CT provides 3-D images, it is often difficult to distinguish tumors from normal tissues with CT scans. MRI provides superior distinction between normal and cancerous tissues, but the technology has not been available to place an MR scanner in the treatment room.

A more robust way to guide radiotherapy would be to image the entire tumor continuously and adjust the radiation beams accordingly. Fallone and his colleagues are testing a prototype Linac-MR system they built to do just that.

Linacs (short for linear particle accelerators) are basically devices that use radio waves to accelerate electrons to high speeds and crash them into a solid metal target — typically tungsten — producing high-energy X-rays in the collision. These high-energy X-rays destroy cancerous cells by causing irreparable damage to the cells’ DNA, MRIs, familiar because of their ubiquity in modern hospitals, are very good at imaging soft tissue and would be an ideal technology for combining with Linacs because most cancers occur in soft tissue.

The problem is making MRIs and Linacs work together. Normally, each one would interfere with the other. Linac systems emit radio waves, which interfere with MRI hardware — so much so that most hospital MRIs are placed in shielded rooms that specifically block radio waves. At the same time, MRIs employ strong magnets that can interfere with Linac systems.

Can two instruments that are not even supposed to be in the same room be combined into one body and be made to work together? This is something that is not possible now says Sawant, but an issue that at least three groups worldwide are examining

Fallone and his colleagues have managed to build a prototype linac-MR device that overcomes the obstacles to integrating the two technologies. It is the first working system to do so.

They have a specialized design that shields the radio frequency waves and magnetic fields. Last December they performed experiments with the system to demonstrate that it works by taking MRI test images with the linac on and off to demonstrate that the interference is eliminated. A working, clinically-ready system is not here yet, but Fallone believes that it will be in five years or so.

In related research, Sawant and his Stanford colleagues Kim Butts Pauly and Paul Keall have been working out the technical details of just how a hybrid MRI+linac system could be used to achieve real-time image guidance. Anyone who has had an MRI scan knows that these procedures are long. Typical imaging times for MRI range from several seconds to a few minutes per image. Sawant says that their goal is to go at least ten times faster. They are developing imaging specifications for a system to accurately image the entire volume of a tumor in real time, about three times per second.

The key to implementing this technology may be to lower the magnetic field of the magnetic resonance used to image a tumor. Powerful hospital MR instruments employ large magnets with strong magnetic fields because these will give the best quality images. Better quality images help doctors spot tumors, and when someone with cancer is diagnosed, doctors prefer to have images that are as clear as possible, for accurate classification of the tumor. Integrating such strong magnets with linear accelerators is expensive and can be technically quite challenging.

During therapy, however, the images need not be the highest quality in order to track the tumors. Doctors simply need to be able to see the tumor boundaries so that they can make adjustments as the treatment proceeds. In Anaheim, Sawant and his colleagues will describe the results of their studies, which indicate the feasibility of such rapid imaging for hybrid MRI+linac systems in order to follow tumors in real time.

Source
American Institute of Physics (AIP)

What if the quality of cancer care could be assessed and improved in “real clinical time” instead of waiting the typical two years it takes for clinical data to be analyzed and changes implemented? That is an opportunity The Cancer Institute of New Jersey (CINJ) Network of hospitals is exploring this summer, as it takes the lead in a national initiative to improve data collection on cancer treatment and create a new quality assessment system that can be utilized by health providers across the country. The CINJ Network of hospitals represents nearly a quarter of the 60 beta test sites from across the country that have been invited to help steer the effort. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

According to the American College of Surgeons Commission on Cancer (CoC), which is overseeing the project, “treatment information in current data collection systems is insufficient to assess the quality of (cancer) care.” That reality is among the reasons why the CoC developed the Rapid Quality Reporting System (RQRS), which the CINJ Network and others will be pilot testing for the remainder of this year.

The first phase, which tested the mechanics of the web-based data collection system, took place during the fall of 2008 and spring of 2009. Modifications based on that testing will be put into practice for this next phase, utilizing existing national 2006 and 2007 data on breast and colorectal cancers. This information will be used as a baseline against which the CoC and participating hospitals can monitor future performance rates. The CINJ Network will be responsible for entering 2008 and 2009 breast and colorectal data from patients at its respective hospitals.

The goal of the RQRS is to provide hospitals and other healthcare providers at the local level with performance feedback on specific patients. One of the ways this will be accomplished is through the RQRS “alert system.” Healthcare professionals will receive real time performance feedback through e-mail alerts as well as through the system itself. One example would be if a woman had a lumpectomy for early stage breast cancer. The usual standard of care would be for her also to receive radiation to the breast. RQRS monitors her case information and notifies the treating hospital and physician if radiation delivery has not been reported as started within a time frame consistent with evidence-based recommended practice. CoC project coordinators view the RQRS as a unique opportunity to use technology to ensure optimal cancer care.

“Will this take the place of an oncologist or other medical professional? Absolutely not,” noted Molly Gabel, MD, deputy director of extramural affairs at CINJ and associate professor of radiation oncology at UMNDJ-Robert Wood Johnson Medical School. “What the system is designed to do is provide comprehensive, up-to-date information in real time so that teams of oncologists can have a ‘report card’ on the care their patients are receiving.”

The CINJ Network also will have input into this monitoring process, which Dr. Gabel says positions it as a nationwide leader in this area. “Being that CINJ has a large network of hospitals participating in the pilot, and because we already operate in a manner which promotes uniformity, the leaders at our Network institutions feel confident that as a group we can help build a quality foundation for the RQRS. We are grateful to the CoC for this opportunity.”

Following completion of the program’s second phase, the CoC will reevaluate the RQRS and make any necessary modifications. Ultimately, the goal is to measure the impact the system will have on promoting the quality of cancer care by assessing performance rate changes at participating hospitals. Through RQRS, local hospitals will be able to compare their performance rates to those of other facilities state and nationwide. It is the hope of the CoC that all of its 1,460 accredited cancer programs across the country will be able to utilize the system by 2011.

Over the last 16 years, CINJ’s Network of hospitals has been instrumental in providing its patients with outstanding cancer programs that emphasize state-of-the-art cancer care through clinical research, prevention and education components across the state. Through affiliation with CINJ, Network hospitals are able to provide access to clinical trials for their patients, available only at NCI-designated cancer centers and their networks. CINJ also provides its Network hospitals with professional education, community education and outreach, and other services that enhance their cancer programs.

Source
The Cancer Institute of New Jersey Network