| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
SPECIAL SECTION |
 |
UNITED STATES NATIONAL INSTITUTES OF HEALTH WINS INCREASE IN APPROPRIATIONS |
|---|
 Top United States National... Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
Considering that last year’s appropriations were similarly favorable for NIH, an argument can be made that the United States government’s biomedical research effort has emerged unscathed from the appropriations battlefields of the Republican Revolution. In fact, as Congress slashed the budgets of other domestic programs in the 1997 fiscal year, NIH received an increase of 6.9%. NCI’s increase was 6%. Last year’s increases were 5.7% for NIH and just under 5% for NCI.
The bill followed the recommendations of the United States House of Representatives, giving NCI and NIH substantially more money than either the United States Senate or the Administration recommended.
These numbers are a clear indication that in the latest appropriations process, Representative John Porter (R-IL), chairman of the Labor, HHS & Education Appropriations Subcommittee, had prevailed in securing and defending his funding targets for NIH.
"Once again, Congress has staked out NIH as one of the most important programs for federal commitment," said Marguerite Donoghue, executive director of the National Coalition for Cancer Research. "This level of support two years in a row is phenomenal."
"Rep. Porter has clearly taken the lead in shaping this, with strong support of Senators [Arlen] Specter and [Mark] Hatfield," Donoghue said to The Cancer Letter. Specter (R-PA) is chairman of the Senate Labor, HHS & Education Appropriations Subcommittee. Hatfield (R-OR) is chairman of the Senate Appropriations Committee.
Several observers said these numbers have a down side as well: the increases are likely to make NIH a target for the constituencies of other programs in the Labor, HHS & Education bill during the upcoming appropriations process. 
|
OXFORD UNIVERSITY PRESS WINS COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) FOR JOURNAL OF THE NATIONAL CANCER INSTITUTE (JNCI) |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
JNCI costs the Institute more than $1.7 million annually and has 15 staff positions. The Institute earns about $1 million from the journal’s 10,000 subscribers, but cannot sell advertising or conduct extensive marketing.
Oxford, the largest university press in the world, was selected in a competition that drew about 20 applicants, sources said. It is the first time the CRADA mechanism, designed to commercialize technology developed by the United States government, has been used to transfer a government publication to the private sector.
Jaclyn Fox, senior editor and manager for United States journals, said Oxford will develop an electronic version of JNCI as part of the agreement. "We are very pleased," Fox said to The Cancer Letter. "Oxford is a nonprofit university press and we felt it was a good fit. We have a very strong journals program, particularly in this area."
Oxford publishes about 160 journals in a variety of academic fields. Carcinogenesis is the organization’s best known oncology journal, Fox said. "One of the main changes will be the ability to market JNCI," she said. "As an international marketing group, we can expand to areas the journal has not reached, such as the Pacific Rim."
Julianne Chappell, managing editor of JNCI, said the Institute chose Oxford for its willingness to uphold the journal’s peer-review and oversight process. "We have made a marriage of like minds," Chappell said. "Oxford is as interested as we are in maintaining the quality of the journal."
Under the agreement, NCI will continue to name the journal’s editor-in-chief, currently Barnett Kramer, deputy director of the Division of Cancer Prevention and Control. Chappell will become executive editor when Oxford appoints a managing editor. Under the agreement, NCI will provide the editorial facilities for five years. The Institute’s staff would gradually go off the journal’s payroll as they are replaced by Oxford staff. NCI officials have said they will try to place staff members in other positions in the Institute. Also at the end of the transition period, NCI’s Office of Cancer Communications will no longer produce the journal’s news section. "At the end of the CRADA period, there will be no taxpayer money going into this journal," Chappell said.
JNCI monographs are included in the transfer, but Oxford will make the funding decisions about publication of monographs, Chappell said.
JNCI was founded in 1940. Last year, the Institute for Scientific Information listed the journal as having the highest "impact factor" among primary journals in cancer research. The impact factor is defined as the average number of times a paper is cited in scientific literature.
|
UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVES THREE NEW ANTICANCER AGENTS |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
Aredia (pamidronate disodium) for injection; for marketing for the treatment of patients with osteolytic bone metastases of breast cancer, in conjunction with standard antineoplastic therapy.
Etopophos (etoposide phosphase) for injection; a new water-soluble version of the anticancer drug VePesid (etoposide).
Gliadel, a wafer impregnated with an anticancer drug, carmustine, for use as an implant after surgical removal of a recurrent tumor of glioblastoma multiforme, an aggressive form of brain cancer.
Aredia: Bone Metastasis of Breast Cancer
Aredia, marketed in the United States by Chiron Therapeutics of Emeryville, CA, through an agreement with Ciba Pharmaceuticals, is the first drug that has been proven to reduce the incidence of skeletal complications of metastatic breast cancer, thereby reducing the need for radiation therapy or surgery to the bone. The drug also has been shown to provide relief of bone pain caused by metastatic breast cancer, reducing the need for narcotic analgesics.
The drug is also indicated for the treatment of osteolytic bone lesions of multiple myeloma, moderate to severe hypercalcemia of malignancy and moderate to severe Paget’s disease.
The market clearance for breast cancer was based on data from two large, placebo-controlled, double-blind, multicenter studies in breast cancer patients with osteolytic bone metastases. These studies enrolled 372 patients treated with hormonal therapy and 382 patients treated with chemotherapy. All patients had stage IV breast cancer with two or more predominantly lytic lesions, with at least one lesion that was one centimeter or greater in diameter.
Patients were randomized to receive Aredia 90 mg every three to four weeks via two-hour i.v. infusions for 12 months or matching placebo, in conjunction with either hormonal therapy or chemotherapy.
The studies demonstrated that patients receiving Aredia had a significant reduction in skeletal complications, the primary endpoint, and significant relief of bone pain, a secondary endpoint. The Aredia treatment effect appeared to be less pronounced in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy. Patients receiving Aredia had fewer pathologic fractures and a decreased need for radiation therapy for pain or skeletal complications.
"Aredia can help improve the clinical management of advanced breast cancer patients and may enhance the quality of life of these patients," said Gabriel Hortobagyi, Professor of Medicine and Chairman of the Department of Breast/Gynecology at the MD Anderson Cancer Center.
Skeletal morbidity was defined as the mean number of skeletal complications per patient per year. In patients receiving concomitant chemotherapy, Aredia provided a 36% reduction in the skeletal morbidity rate (2.1 versus 3.3 with placebo; p<0.01). In patients receiving concomitant hormonal therapy, skeletal morbidity was reduced by 31% with Aredia (2.4 versus 3.5; p=0.05). For an average patient, these reductions mean one fewer major skeletal complication per year with Aredia.
The incidence and type of adverse events with Aredia were similar to those with placebo, with most events likely due to the underlying disease or antineoplastic therapy. The most frequent adverse events were fatigue, fever, nausea, vomiting, anemia, and skeletal pain. Transient arthralgias and myalgias were reported slightly more frequently with Aredia than with antineoplastic therapy alone (12% and 23% versus 8% and 17%). Serum calcium and electrolytes must be closely monitored, as must patients with pre-existing anemia, leukopenia, or thrombocytopenia.
Etopophos: Lung Cancer
Etopophos, sponsored by Bristol-Myers Squibb Co. of Princeton, NJ, can be administered in as little as five minutes, an advantage over the 30- to 60-minute infusion time required for VePesid, the company said. The new drug also can be given to patients in higher concentrations than VePesid, reducing by up to 1/50th the fluid volume infused.
Etopophos carries the same indication as VePesid, to be used in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer and as combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgery, chemotherapy, and radiotherapy.
The most common side effects associated with Etopophos are nausea and vomiting, hair loss, impairment of bone marrow cell production, and lower than normal white blood cell levels.
Gliadel: Glioblastoma
Gliadel is manufactured by Guilford Pharmaceuticals Inc., Baltimore, MD. The wafer is implanted in the brain to deliver cancer therapy directly to the tumor site with less exposure to the rest of the body.
Gliadel was approved based on the results of a multi-center placebo controlled study in 222 patients who had recurrent malignant glioma after initial treatment with surgery and radiation therapy. Following surgery to remove the tumor, half of the patients were treated with Gliadel implants and half with placebo. In patients with glioblastoma multiforme, the six-month survival rate increased from 36% with placebo to 56% with Gliadel. Median survival increased from 20 weeks with placebo to 28 weeks with Gliadel. In patients with pathologic diagnoses other than glioblastoma multiforme, Gliadel had no effect on survival.
The results were supported by a small study conducted in 32 patients who received either Gliadel or placebo after undergoing initial surgical resection and radiation for malignant glioma.
Gliadel wafers are implanted into the cavity left in the brain after surgical removal of the brain tumor. The wafers deliver the active drug carmustine directly to the affected area of the brain. Depending on the size of the cavity, 7 to 8 wafers are implanted. Each wafer is 1.45 cm in diameter, 1 mm thick and contains 7.7 milligrams of carmustine, resulting in a 61.6 mg dose when eight wafers are implanted. Following implantation, patients should be monitored closely for possible complications such as seizures, infections, abnormal wound healing and swelling of the brain, FDA said.
FDA’s approval follows a June 15 recommendation by the agency’s Oncologic Drugs Advisory Committee.
|
MYRIAD MAKES ITS COMBINED BRCA1, BRCA2 TEST AVAILABLE |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
Myriad will begin accepting samples October 30, 1996, through its genetic testing facility, Myriad Genetic Laboratories. BRCA1 and BRCA2 gene mutations are responsible for about 90% of all early-onset hereditary breast and ovarian cancers.
Myriad said it has combined full-DNA sequencing of both genes to create BRACAnalysis, a comprehensive test for hereditary breast and ovarian cancer susceptibility.
Myriad has provided an unrestricted grant to the Dana-Farber Cancer Institute for establishing a confidential, voluntary patient registry for women who have been tested for BRCA1 and BRCA2 mutations. The purpose of the registry is to collect additional information that will help to establish the risks of developing breast/ovarian cancer associated with different mutations of these genes. The information will also be useful in determining which medical interventions are most effective in the care of patients, the company said.
In the BRACAnalysis process, Myriad performs over 80 separate PCR amplifications and examines more than 16,500 DNA base pairs. The process requires 10 working days. The fee for the comprehensive genetic analysis is $2,400, the company said. Once a gene mutation has been identified, at-risk family members are offered an analysis for that specific mutation for $395. Myriad has established an assistance program to help patients ordering the test to obtain reimbursement.
The company said BRACAnalysis is primarily intended for individuals who are at high risk of hereditary breast or ovarian cancer and those with a diagnosis of breast (especially premenopausal) or ovarian cancer.
Before a physician orders BRACAnalysis, Myriad recommends that the patient undergo education and counseling. Myriad said it has enlisted the cooperation of genetic counselors to develop the Genetic Counseling Resource Directory, a national directory of qualified professionals with experience in cancer counseling.
|
ONCOR MED EXPANDS TESTING FOR BREAST, OVARIAN CANCER |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
After November 1, the availability of the service will be expanded to all high-risk Ashkenazim without requiring prior testing of an affected family member, the company said.
The Heritage Panel looks for three genetic mutations linked to hereditary breast and ovarian cancer, which include two mutations in the BRCA1 gene and one in the BRCA2 gene, the company said. About 2% of Ashkenazi Jews are believed to carry these mutations.
The company has offered BRCA1 testing since mid-1995, and recently added BRCA2 testing. The Heritage Panel will continue to be offered under a protocol approved by an Institutional Review Board. The protocol defines eligibility and contains requirements for counseling of individuals being tested.
|
CHIRON REPORTS PHASE III RESULTS FOR DEPO CYT |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
The clinical trial was a multicenter, controlled, non-blinded study of DepoCyt, in which 61 patients were randomized to treatment either with DepoCyt or MTX. Patients initially received a dose of DepoCyt every 14 days, compared to twice per week dosing with MTX.
NM occurs when metastases from solid tumors, leukemia, or lymphoma spread to the tissue surrounding the brain and spinal cord.
DepoCyt is an injectable, sustained-released formulation of the chemotherapy agent cytarabine encapsulated in DepoFoam, DepoTech’s proprietary lipid-based drug delivery technology.
Chiron and DepoTech plan to continue pivotal phase III studies of DepoCyt in NM arising from leukemia and lymphoma. In addition, a multicenter phase IV study of DepoCyt for the treatment of NM arising from solid tumors is under way in the United States and Canada to collect further data relating to safety and efficacy, the company said. Chiron is currently conducting clinical trials of DepoCyt in Europe, the company said.
|
COMPANIES IN BRIEF |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
Taxotere is approved in the United States for the treatment of locally advanced or metastatic breast cancer in patients who have progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy. Taxotere is not approved in the United States for non-small cell lung cancer, although phase III studies are ongoing, the company said.
FDA has cleared for marketing an expanded indication for ABELCET (Amphotericin B Lipid Complex Injection), a drug developed and marketed by The Liposome Company Inc., of Princeton, NJ. The expanded indication is for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy.
This represents a significant broadening in the indicated uses for the drug to include candidiasis, the most common type of invasive fungal infection, and cryptococcal meningitis, a relatively common infection of AIDS patients, as well as less frequently encountered infections such as zygomycosis, fusariosis, and others.
ABELCET is currently marketed in the United States for the second-line treatment of aspergillosis and is the only lipid-based amphotericin B product on the United States market. The company is conducting additional phase IV studies of ABELCET to continue to enhance the clinical data available on the product.
Until the advent of lipid-based products, conventional amphotericin B was generally considered to be the treatment of choice to combat these infections in spite of its propensity to cause kidney toxicity, the main dose-limiting factor.
Neoprobe Corp. and United States Surgical Corp. signed an exclusive agreement granting US Surgical exclusive worldwide sales and distribution rights for Neoprobe’s RIGS (radioimmuno-guided surgery) products for surgical detection and treatment of cancer, the companies said. The agreement excludes Korea, Thailand, Taiwan and Singapore.
"Our agreement with Neoprobe will help surgeons around the world make significant advances in cancer treatment by providing an important new technology that can find hidden metastasized cancers not detected visually or through palpation," said Leon Hirsch, US Surgical chairman. "RIGS products can be used in the more than 400,000 colorectal surgeries performed annually worldwide."
When RIGS is used, the patient is injected prior to surgery with a Neoprobe drug that targets and attaches to the cancer cells. During the procedure, the surgeon scans the abdomen with a small hand-held probe. If cancer cells are present, the probe emits an audible tone, identifying the precise location of the diseased tissue.
US Surgical will provide surgeon and professional training worldwide for RIGS products and will help fund future research, the companies said. Neoprobe retains primary responsibility for product development and manufacturing.
Neoprobe said it anticipates European Medicines Evaluation Agency approval during the first half of 1997. The company said it has completed phase III clinical trials for FDA, and expects to submit a Biologic License Application shortly.
|
FOOTNOTES |
|---|
|
TopUnited States National...Oxford University Press Wins...United States Food and...Myriad Makes its Combined...Oncor Med Expands Testing...Chiron Reports Phase III...Companies in Brief |
|---|
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | CONTACT US | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| THE ONCOLOGIST | STEM CELLS | CME | ALPHAMED PRESS JOURNALS |
