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Brain Cancer News for September 2004
Stop construction of cellsites: Boking
By Rhay G. Navales
MABALACAT -September 14, 2004- Mayor Marino "Boking" Morales Monday urged the Municipal Council here to look into ailments contracted by Barangay Duquit residents allegedly due to low-intensity radiation transmitted by cellsite antennas in the area.
At the same time, Morales also exhorted the Municipal Council to pass a resolution that will stop the construction of cellsite towers in the town.
"I'm for the relocation of the antennas if it will be proven that it is hazardous to humans. We cannot sacrifice the health of our constituents," Morales added.
Members of the Alyansang Tagapangalaga ng Kalikasan at Kapaligiran (Atakk) met with the mayor Monday afternoon and discussed the ill-effects of radio microwave transmitted by cellsite antennas to humans.
The group also informed the mayor of the several cases of death and illnesses of residents residing near the two cellsite towers in Barangay Duquit.
Atakk chairperson Vicky Gragas said it is possible that the radiation transmitted by the towers caused the residents' illnesses, which already reached an alarming number.
She claimed that exposure to radio microwaves would cause Alzheimer's disease, leukemia, cataract, brain tumor, reproductive disorders, cancer, brain cell damage, poor blood circulation, senility, among others.
Morales asked the environmentalists' group to furnish his office and the Municipal Council with documents that will prove the effects of cellsite transmitters to human life.
Earlier, Gragas revealed that three children residing some 20 meters away from the two cellsites in Duquit recently died for unknown reasons.
A 52-year-old man, whose house fronts one of the towers, died last week because of brain tumor, Ragas said.
She also cited two cases of leukemia, a lung cancer, and several cases of mouth and nose bleedings.
Gragas thanked Morales for his immediate action on the issue.
Disease scare erupts in Melbourne hospital
The World Today - Monday, 13 September , 2004
Reporter: Rachel Carbonell
ELEANOR HALL: A Creutzfeldt-Jakob Disease scare has erupted in a major Melbourne hospital this morning. The Royal Melbourne Hospital has contacted more than 1,000 patients after the disease was discovered.
The Hospital says it is the non variant strain of CJD, that is the strain that is not related to mad cow disease, and the likelihood that other patients have been infected is extremely low.
But it will now spend about a million dollars replacing 15,000 surgical instruments and treating another 300,000 with a special sterilisation unit.
Rachel Carbonell reports from Melbourne.
RACHEL CARBONELL: Creutzfeldt-Jakob Disease is one of the only diseases where the proteins that cause it can survive the normal hospital sterilisation procedures for surgical instruments.
The Royal Melbourne Hospital scare erupted when it was revealed this morning that a man who had been operated on twice last year was later revealed to have the rare disease.
The middle-aged patient underwent surgery twice to treat a malignant brain tumor, but later died. Before he died he developed severe dementia and an autopsy revealed he had sporadic CJD.
Today the hospital's Director of Surgery Professor Andrew Kaye held a press conference to address concerns about the case.
ANDREW KAYE: And there's never been a proven case of transmission of CJD between patients through surgical instruments in the past 30 years. And expert advice is there is only extremely remote, extremely remote risk of transmission in this particular case.
We have today written to 1056 patients, inviting them to contact us or asking them to contact us. And we've withdrawn some of our neurosurgical instruments and begun long cycle sterilizing of our entire stock of 300,000 surgical instruments on advice of the national CJD (inaudible) reference group.
We've been working in close consultation with the Department of Human Services and Federal Government bodies in developing our response.
We have a media conference today because it is important the community understands this is an extremely rare disease and this has not, I repeat has not, arisen because of any breach of protocol or guidelines.
Now, it's very important not to be misled by the understandably emotive label associated with this incident. There are risks associated with every surgical process and as the statistical evidence clearly demonstrates this incident does not mean our patients should be alarmed. Our patients should not, our patients should not be alarmed.
This hospital prides itself on giving its patients a full and transparent picture of the processes involved in their treatments, the possible outcome and their individual prognoses.
The hospital has never regarded this obligation as ceasing on completion of an individual patient's treatment. Our patients should regard the communication of this instance as a responsible manifestation of the hospital's concern that the full and transparent picture of which their hospital aims remains just that.
Patients are entitled to see this as a positive affirmation of patient care and not as a cause of individual patient alarm.
Now I'm asking you, ladies and gentlemen of the press, to be responsible in the reporting of this incident.
RACHEL CARBONELL: Sporadic CJD affects only one in a million people and there are about four cases of it in Victoria each year. It's related to variant CJD, otherwise known as Mad Cow Disease, but isn't the same. To date there have never been any cases of Mad Cow Disease in Australia.
ELEANOR HALL: Rachel Carbonell reporting from Melbourne on that scare at the Royal Melbourne Hospital.
Salmedix, Inc. Announces the Initiation of Two New Clinical Trials
BIOWIRE2K
SAN DIEGO--(BUSINESS WIRE)--Sept. 30, 2004--
A New Phase II Study of SDX-101 for Chronic Lymphocytic Leukemia, and a Cooperative Group Study of SDX-102 for Brain Cancer
Salmedix, Inc. announced today the initiation of two new clinical studies. A new Phase II clinical study of SDX-101, or R-etodolac, for patients with Chronic Lymphocytic Leukemia ("CLL") has begun enrolling patients in Sweden, Germany and the UK, and is expected to begin enrolling in France and Poland in the near future. This study is an open-label, randomized Phase II clinical trial in which 80 patients with CLL will receive a standard chlorambucil regimen alone or in combination with SDX-101 for multiple cycles. Response rate, using standardized response criteria, will be the primary endpoint. Duration of response will also be evaluated.
"In this new study, we are investigating the utility of SDX-101 in combination with chlorambucil, which is currently one of the regimens used as frontline therapy in CLL patients," stated Pratik Multani, MD, VP of clinical development for the company. "The study is based on data from a previous clinical trial of SDX-101 as a single agent which was presented at the 2003 American Society of Hematology annual meeting by Dr. Markus Jensen from the University of Cologne, Germany. In that dose escalation study in patients with CLL, a total of 43 patients in groups of six to eight were treated twice daily with increasing doses of SDX-101 for up to eight weeks. This prior trial demonstrated clinical activity with an acceptable safety profile. A greater than 25% reduction in absolute lymphocyte count, or ALC, was observed in 73% of patients receiving SDX-101 at doses equal to or greater than 1000 mg twice per day. The maximal ALC decline averaged 48% and typically occurred within four weeks of starting treatment. Following cessation of SDX-101 therapy, ALC generally returned to pre-treatment values. The company believes that this return to pre-treatment values suggests the need for longer duration therapy or use of SDX-101 in combination with other agents active in CLL. In this prior eight-week study, SDX-101 was generally well tolerated with the majority of adverse events defined as mild or moderate, defined as Grade 1 or 2."
On September 17, 2004, a Phase I/II clinical study of SDX-102, or l-alanosine, in patients with previously treated brain tumors was initiated by the New Approaches to Brain Tumor Therapy, or NABTT, a consortium funded by the National Cancer Institute. As the sponsor of the trial, Salmedix is providing clinical supplies of SDX-102 and will be responsible for regulatory filings. NABTT will conduct this trial independently under a standard clinical trial research agreement.
Salmedix has another Phase II trial under way with SDX-102 in advanced stage patients with non-small cell lung cancer, pancreatic cancer, mesothelioma, soft tissue sarcoma and osteosarcoma who have generally failed one or two prior drug regimens.
About Salmedix, Inc.
Salmedix is an oncology drug development company with a commercial focus on the treatment of hematologic malignancies, or blood cancers, with three clinical-stage product candidates, Treanda(TM), SDX-101 and SDX-102. Salmedix maintains its corporate headquarters in San Diego, California.
Forward-Looking Statements
Salmedix cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Salmedix that any of its plans will be achieved. Forward-looking statements include statements related to the ability to enroll the patient numbers required for each trial, that future clinical trial results will support prior findings, or that such future clinical trial results will support regulatory approvals required to market a commercial drug. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Salmedix's business including, without limitation, difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products, unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims, the scope and validity of patent protection for its products, competition from other companies, and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement, as well as the factors disclosed in the Company's filings with the U.S. Securities and Exchange Commission. Salmedix undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Brain Tumor Study Recruits Hundreds
Data From Large Group Could Offer Clues to Rare Disease
What causes brain tumors, those rare and seemingly mysterious cancers?
No one knows, and the reason researchers have had trouble finding solid clues is because relatively few people develop the disease, which accounts for 1% of all cancers and affects 18,400 Americans annually, according to the American Cancer Society. It also has a high mortality rate, so scientists have a small number of patients to study.
Now, however, a team of M. D. Anderson epidemiologists is conducting a study of what they believe is one of the largest groups of brain cancer patients in the world, says the study’s principal investigator, Melissa Bondy, Ph.D., a professor in the Department of Epidemiology. The goal is to find clues that might lead to an improved understanding of the disease, better testing and, perhaps, more effective treatment.
Study expanded to increase participation
The researchers originally opened the Harris County Brain Tumor Study to M. D. Anderson patients living in Harris County. After finding only one patient from the area, the study expanded to include Texans being treated for brain cancer in any of nine Houston hospitals, including M. D. Anderson.
Now the study, entering its fifth year, includes 434 patients, as well as 183 others who make up a “control” or disease-free, population, which allows a comparison of risk factors.
Participants wishing to enroll must be:
Diagnosed with a glioma, a type of brain tumor, on or after Jan. 1, 2001
Between the ages of 20 to 75 at time of diagnosis
A Texas resident treated at M. D. Anderson or one of eight Houston hospitals:
Methodist
St. Luke’s
Ben Taub
Veteran’s Administration
Memorial Hermann Memorial City
Memorial Hermann Southwest
Memorial Hermann Northwest
Northwest Radiation Associates
Participants are asked to:
Give one blood sample to be used in genetic laboratory research
Fill out a nutritional questionnaire
Answer interview questions about themselves
Where they have lived in the last 15 years
What they have been exposed to physically
Those exposures include “everything from the type of water they drink to the places where they work,” says Phyllis Adatto, study research manager. “We are looking at the influences of hereditary traits, and environmental aspects, as well as the interaction between these two groups of factors.”
The research, which involves study of the blood samples, will be relevant to brain tumor patients worldwide, Bondy says.
“I have been hoping for such a wealth of data my entire career,” Bondy says. “Now, with the generous help of Texans, we hope to make progress.”
For more information or to enroll in the trial, contact trial coordinator Phyllis Adatto at (713) 745-2489.
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