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Legislation
Return of Dingell-Waxman-Kennedy FDA
oversight expected with Democratic control of Congress; drug safety legislation
to advance, Von Eschenbach confirmation seen soon
By Ken Reid, Editor
Until the Republicans took control of the House and Senate in 1994, the two most-feared investigators of FDA issues, Rep. John Dingell (D-MI) and Henry Waxman (D-CA) were in charge of key committees in the House, and their Senate counterpart, Edward Kennedy (D-MA), ruled over the Health and Human Resources Committtee.
As Chairman of the House Energy & Commerce Committee, and its Oversight and Investigations Subcommittee, Dingell was responsible for unearthing the generic drugs payoff scandal at FDA in 1988-89, preparing a blistering report criticizing the agency’s regulation of medical devices in 1993 and assorted investigations into seafood safety, pacemakers, anesthesia machines and of course, drug pricing.
Waxman also investigated FDA at length as chairman of the Energy & Commerce Committee’s Health and Environment Subcommittee. He is responsible for generic drugs legislation in 1984 and the Safe Medical Devices Act of 1990, and also investigated the drug and device industries.
Now, with the Democratic takeover of the House and Senate in the Nov. 7 elections, Dingell is poised to again chair the Energy & Commerce Committee, and Waxman the Government Reform Committee, which also has substantial power in overseeing federal agencies, including FDA. Waxman is also second to Dingell on the Commerce Committee in terms of seniority, and he could chair the Oversight & Investigations Subcommittee, according to an industry source.
Late tonight (Nov. 8), the Senate went to Democratic control, thus assuring that Kennedy will take the reigns of the Health, Education, Labor and Pensions (HELP) Committee, the successor of the Health and Human Resources Committee.
For the three senior Democrats, FDA is ripe for investigation. Since 2001, when President Bush came into office and the GOP controlled both houses, oversight of the agency has been lax. The prospects for getting legislation through Congress to reform drug safety and clinical trials oversight have been poor. Virtually the only oversight of FDA has come from Sen. Charles Grassley (R-IA), regarding drug safety, but he chairs the Finance Committee, which has no say over the Food, Drug & Cosmetic Act or Public Health Service Act.
Now, the Enzi-Kennedy drug safety bill in the Senate —The Enhancing Drug Safety and Innovation Act of 2006—has new meaning, and oversight of FDA could happen quite quickly. That bill was introduced in August: See http://www.fdainfo.com/bicoonlinepages/bicoonline080706.htm.
According to Reuters, there is discussion of making changes in the Medicare
Rx drug program as part of budget legislation or the renewal of user fees paid
to FDA, which is forthcoming. There also will be pressure to allow greater
importation of prescription drugs from
The user fee bill poses the biggest risk for drug makers because it could give Democrats an opportunity to pass tougher post-approval regulation of medicines, importation of cheaper drugs and possibly a limit on consumer-directed advertising, one analyst told Reuters.
Key Democrats also have promised aggressive congressional oversight of drug pricing and other issues.
“You have to ask what [the Democrats] don't like. They don't like Big Pharma. They're going to have a big target on their backs,” Patton Boggs lobbyist John Jonas said.
But WBB Securities analyst Steve Brozak, who made an unsuccessful bid for Congress as a Democrat in 2004, said he did not believe drug makers would become Democrats' favorite whipping boys if they regain power. Instead, he sees the hammer coming down on the FDA and other agencies. “It doesn't do (Democrats) any good to criticize an industry they've got to turn to find the new drugs to deal with the aging baby boomers,” Brozak said.
Whether the Senate is taken over by the Democrats still remains in doubt, as
races in
According to an AP story, “the long-term outlook for companies in the biotechnology and homeland security businesses may benefit, analysts said, from anticipated Democratic efforts to promote stem-cell research and inspect more cargo containers at ports. But the heightened scrutiny of other sectors, ranging from drugs to defense to energy, could cast a shadow that darkens their prospects on Wall Street.”
“The drug industry is on the top of the list of industries that would be uncomfortable if Democrats are successful in the elections,” Ira Loss, an analyst at Washington Analysis, told AP. That’s because House Speaker-presumptive Nancy Pelosi (D-CA) has promised legislation that would allow the government to negotiate directly with drug companies to purchase medicines for Medicare. The drug industry equates the concept to price controls.
Ahead of the voting, drug makers are giving more campaign cash to Republicans. The pharmaceutical and health products industries have contributed more than $9 million to Republican congressional candidates and $4 million to Democrats, according to the nonpartisan Center for Responsive Politics.
Generally speaking, Democrats have said they will differ from Republicans by being tougher watchdogs of corporate wrongdoing and government spending and bigger defenders of consumers and labor unions, according to the AP story. Dingell, the oldest serving member of the House, has a reputation for being particularly gruff and tough with witnesses.
Dingell told the Detroit News on Nov. 3 that he will use his regained authority on the wide-ranging committee to press for more Medicaid assistance to states, allow the federal government to buy drugs in volume to get discounts for Medicare Part D and push for universal health care. FDA oversight was not listed.
According to the Capitol Hill-oriented newspaper “Roll Call,” leadership of the House will fall to Democrats, with Pelosi becoming the first female House Speaker. House Minority Whip Steny Hoyer (MD) issued a statement confirming that he will make a bid for Majority Leader. Like Dingell, Hoyer comes from a state with a drug-device industry presence, but their districts do not have much pharmaceutical, device or biotech employment.
“As part of the leadership team that helped regain the House Majority, I would like to continue to serve House Democrats as their Majority Leader,” Hoyer said. “Over the past several months, I have talked with almost every one of my House colleagues and Members-elect, and am grateful for the depth of support I have received.”
House Democratic Caucus Chairman James Clyburn (SC) also issued a letter to fellow Democrats on Wednesday confirming his intentions to seek the Majority Whip’s office in the next Congress. “The Majority Whip is the third-ranking elected leadership position. This will be consistent with my rank as Chairman of the Democratic Caucus, our current third-ranking position,” wrote Clyburn, who cited his leadership experience, including a former Congressional Black Caucus chairmanship and three years as the Caucus vice chairman.
While no other contenders for the Whip’s office had announced Wednesday
morning, it is possible that House Democratic Congressional Campaign Committee
Chairman Rahm Emanuel (D-IL), who has said he will
not serve a second term in his current post, could make a bid for the office,
although a spokeswoman declined to confirm his interest. Chief Deputy Minority Whip Diana DeGette (D-CO)
is expected to make a bid for the office if Emanuel does not enter the
race. DeGette was co-sponsor of bills in
prior years to boost federal rules regarding human subject protections.
The Caucus is scheduled to hold its leadership elections Nov. 16, Roll
Call reported.
Although more oversight can be expected, it may take time, too. Many of the investigators and staff on the
Dingell committees were cut back when the GOP took control of Congress. So, a lot of new hires would have to be in
place first before the Dingell-Waxman-Kennedy triumvirate gets revved up again.
PhRMA
Despite the
prognosis of more oversight and efforts to reign in drug prices and
restrictions on prescription drug imports from
“We look forward
to working with all members of the new Congress to solve the difficult and challenging
health care problems that confront
But PhRMA also was quick to criticize any efforts
to weaken the Medicare prescription drug program, or to relax rules on
importing drugs from
Regarding drug pricing and the
Medicare prescription drug benefit, Johnson said, “Critics infer that there are
no negotiations in how prices for medicines are set. That’s simply not true.
The negotiations are occurring – as they should be – between prescription drug
plans, several of which already purchase medicines on behalf of tens of million
of Americans, and pharmaceutical companies. That’s the marketplace in action
and that’s how
He added: “The non-interference clause of the Medicare
Act protects against the federal government limiting patients’ access to medicines
they need. These protections do not compromise affordability. Even the
Congressional Budget Office has said that government interference ‘would have
a negligible effect on federal spending’ and that the government probably could
not negotiate lower costs than the powerful private sector purchasers already
negotiating for lower costs.”
Ethics
ORI
asks for comments on research misconduct policy
The Office of Research Integrity (ORI) is inviting public comments on its “Model Policy for Responding to Allegations of Research Misconduct.” The policy has been revised to comply with the Public Health Service Policies on Research Misconduct (42 C.F.R. Part 93). Under that policy, research misconduct is defined as:
The policy specifically states, “Research misconduct does not include honest error or differences of opinion.”
ORI’s Model Policy “… was designed primarily for use by institutions that are developing or refining their policies for handling scientific misconduct cases where ORI has jurisdiction.” It is, the agency noted, “non-binding and…has been developed to provide suggestions to institutions” to ensure that their own research misconduct policies are consistent with 42 CFR Part 93.
Further, the policy states that “institutions may adopt additional standards of conduct that go beyond the PHS standards in 42 CFR Part 93. These additional standards may be included in the same policy document as the PHS standards, but if an institution chooses that option, it should make certain that the two sets of standards and actions under them are easily distinguishable. These additional institutional standards will apply only to the internal decisions at the institution.”
The Model Policy can be read in full at http://www.ori.dhhs.gov/policies/model_policy.shtml. Comments should be sent to Brenda.Harrington@hhs.gov by Dec. 29.
Proven stem
cell cures being thwarted by politics, says advocate for the blind
RP International, a Los Angeles-based organization dedicated
to raising funds for research into the causes of and treatments for blindness,
will establish a new and separate fund-raising campaign to aid development of
adult stem cell treatments for blindness and other disorders, its founder and
president announced.
Helen J. Harris said in a release issued by the company that proven
cures for blindness using adult stem cells are already available but are being
stymied by politics. Although the main political controversy revolves around
the use of embryonic stem cells, politics has infected the entire scientific
field and has stalled adult stem cell applications as well, she stated.
Acrimonious political campaigns have spread misunderstanding and
discouraged funding of all stem cell research in the
Harris and two of her sons are blind due to retinitis pigmentosa. Her
organization's 2006 Vision Awards took special note of adult stem cell research
by honoring a patient who was able to regain sight thanks to the LSU technique
after more than 20 years of blindness.
The chilling effect on stem cell research has not been limited to the
LSU program, Harris said, but is a factor holding back research all around,
including money that could go to adult stem cell applications. She cited the
example of
Clinical Trials
Links to
depression, anxiety may delay
Sanofi-Aventis may face delays in introducing its anti-obesity drug Acomplia in the United States, the company announced, according to a report in the Oct. 31 “International Herald Tribune.”
Sanofi executive Hanspeter Spek told the newspaper that Sanofi
submitted new information to FDA, but he could not offer a timeline for
approval. FDA has not required more clinical trials, but some analysts have
speculated that
Sanofi, the world's third-largest drug company by sales after Pfizer and GlaxoSmithKline, said in February that
Acomplia works by reducing the patient's urge to overeat and by
adjusting the body's metabolism of fats and sugars, according to Sanofi. The
drug helps to reduce body weight as well as levels of blood sugars and bad
fats, while boosting good cholesterol.
Marketing of Acomplia was first approved by EMEA in June. Since then,
Sanofi has introduced the drug in
Vaccines
Bavarian
Nordic reports progress in new smallpox vaccine program
Bavarian Nordic reported that it is in continuing dialogue
with Department of Health and Human Services (HHS) officials on its proposal to
supply the government with its Imvamune smallpox vaccine under the Project BioShield
program.
While the timing of an award decision is not known, intensive efforts
are underway to conclude the process, according to information the company has
received from government officials. Earlier in the year, the government
announced plans to acquire a new smallpox vaccine for persons who are
immune-compromised and at risk for developing serious complications from the
smallpox vaccine currently stockpiled.
Bavarian Nordic’s Imvamune smallpox vaccine is being developed for
immune-compromised persons who may experience serious side effects from the
traditional vaccine currently stockpiled by the
Bavarian Nordic stated that more than 1,200 persons, including healthy
volunteers, people with atopic dermatitis and those with HIV infection, have
been vaccinated in three additional Phase II trials with Imvamune without
serious or unexpected side effects. Safety data generated from these studies
are a key requirement for filing and receiving an Emergency Use Authorization
for Imvamune in the
The company's research facility in
Researchers
hope to kill many flus with one shot
At least 28 bird flu vaccines are under development by 13 different companies worldwide, according to the International Federation of Pharmaceutical Manufacturers & Associations. But while most drug companies design flu vaccines to generate antibodies that neutralize hemagglutinin and neuraminidase, which are likely to mutate, Dynavax Technologies in Berkeley, CA, has developed an influenza vaccine that targets two common flu proteins, the nucleoprotein and matrix protein, which tend to remain stable.
According to an article in the “San Mateo Times,” Dynavax believes that if some bird flu virus proteins mutate, their vaccine still would be effective against the proteins that do not change.
The Dynavax vaccine, like all
bird flu vaccines, is in an early stage of development. But on Oct. 20, the
company presented data at the Second International Conference on Influenza
Vaccines for the World in
Scientists at Vical Inc. in
Most people have at least a degree of immunity to seasonal flu, because they have been exposed to the virus at some time in their lives. But because bird flu is new, no such previously developed immunity exists. As a result, fairly large dosages of bird flu vaccine would be required to provide protection against the virus.
Novartis AG, which acquired Chiron
and its
Yet another concern is how to manufacture enough doses of bird flu vaccine quickly for the billions of people around the world who might need it. The typical method of making flu vaccines, which partly involves growing the virus in fertilized chicken eggs, would require vaccine manufacturers to obtain millions of eggs on short notice. However, the virus could kill many of the chickens counted on to produce those eggs, and greatly increased egg production requires substantial advance notice to farmers.
To avoid that problem, federal
authorities have awarded Novartis and MedImmune
a total of nearly $400 million over the next five years to make vaccines from
a process using mammal cell cultures. The ingredients for such cultures can
be stored in freezers and be instantly available in the event of a health emergency.
They also tend to be less bulky than eggs. Cell-based vaccines also seem to work as well
as those derived from eggs, according to data Novartis presented Oct. 19 at
the
FDA
management
Stephen Mason, a former Director of Government Relations at the Generic Pharmaceutical Association (GPhA) is joining FDA as a Senior Advisor in the agency’s Office of Legislation, effective Nov. 13.
In this role, Mason will work closely with David Boyer, Assistant Commissioner for Legislation, on a wide variety of issues pending before Congress, most notably generic drug legislation.
Mason
comes to FDA after a diverse career in both regulated industry and on Capitol
Hill. Prior to joining GPhA, Mason held several other positions, including
Legislative Aide to Congressman John Ensign. In this position he directed
legislative issue management and fostered policy development on an array of
issues, including health care. He earned a Bachelor of Science, Business
Administration-Finance at
People
Genetics
researchers Jeffery Vance and Margaret Pericak-Vance will be moving from
A
group of about 20 researchers will be moving with the Vances, and is expected
to bring with it millions of dollars in annual funding from NIH.
R&D
Melior
announces research collaboration with Merck
Melior
Discovery announced on Nov.
7 that it has signed a research collaboration with Merck & Co. to evaluate the activity of select Merck
neuroscience compounds utilizing elements of Melior's in vivo Indication
Discovery platform. Under the terms of the agreement Merck will pay undisclosed
fees for priority access to aspects of Melior's exclusively licensed platform.
Melior Discovery is using its Indication Discovery platform of multiplexed
in vivo models to both build an internal pipeline of development candidates
and to share this capability with pharma and biotechnology company partners.
In the former case, the Company is identifying “privileged” compounds that have
been discontinued by other firIn its partnered arrangements,
Melior offers pharmaceutical partners an approach to expand their late-stage
pipelines with high-quality drug candidates that originated from internal R&D
efforts.
Avalon Pharmaceuticals initiate drug
discovery program for the survivin pathway
Avalon Pharmaceuticals, a biopharmaceutical company focused on the
discovery and development of small molecule therapeutics, has announced the
initiation of a drug discovery program for the survivin pathway, an important
and intractable cancer pathway. Survivin is overexpressed in multiple tumor
types, including breast, lung, prostate, pancreatic and colon cancers. Survivin
is cancer selective, as it is broadly expressed in most tumor types but
undetectable in most normal adult cells.
The company’s AvalonRx technology identifies potential therapeutics based
upon their ability to modulate pathways or targets within living cells.
Avalon's pipeline now includes AVN944, an IMPDH inhibitor in Phase I
clinical trials for hematological malignancies; Beta-catenin and
Trial
Updates
Adolor and partner GlaxoSmithKline said FDA has asked for more safety data, including an analysis of "serious cardiovascular events," from an ongoing clinical trial of Entereg, an experimental drug for treatment of postoperative ileus. FDA issued a second “approvable” letter for Entereg, but requested 12-month safety data, as well as a risk management plan to monitor the drug for serious side effects, if approved. FDA issues approvable letters when the agency wants more information on drugs it believes can be approved. For more details see: http://www.therapeuticsdaily.com/news/article.cfm?contentValue=388444&contentType=newsarchive&channelID=29
AstraZeneca announced its intention
to expand the development plan for CytoFab, a treatment for severe sepsis, with
the addition of a 480-patient Phase II study program. Consultations with regulators
in the
Elbit Medical
Imaging announced that its
subsidiary, Gamida Cell, developer
of stem cell therapeutics, has reached an agreement under a Special Protocol
Assessment (SPA) with FDA on the design of the global, pivotal, historical controlled,
registration study of StemEx for the treatment of hematological malignancies.
Gamida Cell is developing StemEx in a Joint Venture with Teva Pharmaceutical
Industries Ltd. In response to the SPA application, FDA responded that the design
and planned analysis of the study sufficiently address the study's objectives
and that this study is adequately designed to provide the necessary data that,
depending upon outcome, could support a license application submission. StemEx
may provide an alternative source of stem cells for these patients by enabling
the use of cord blood for transplantation. StemEx is composed of ex-vivo expanded
cord blood stem/progenitor cells, which are transplanted in combination with
non-expanded cells from the same cord blood unit. The Phase I/II study of StemEx
conducted at the M. D. Anderson Cancer
Center in
FlowCardia announced the enrollment of the first patient
into the 10-hospital, 85-patient PATRIOT (Peripheral Approach To Recanalization
In Occluded Totals)
Morphotek announced that FDA has granted orphan drug
status to MORAb-009, a monoclonal antibody, for the indication of pancreatic
cancer. MORAb-009 is an antibody that recognizes mesothelin, a cell surface
glycoprotein overexpressed in a number of cancers. Researchers at the National
Cancer Institute (NCI) and
Scientific Intake announced on Nov. 7 that it has completed enrollment
of 190 subjects for its multi-site clinical trial of a new weight loss device,
and will seek FDA market clearance for the device. Scientific Intake's device
simulates a physical condition linked with thinness called Torus Palatinus.
The device contains a wireless microsensor linking patients and providers for
remote monitoring of compliance, behavior change and progress. The mode of action
of the investigative product physically increases savoring, reduces bolus size,
slows intake and allows the body's built-in defense mechanism, the satiety response,
to trigger. Device users in earlier studies reported feeling satisfied while
food intake was reduced by 23%. Study completion is scheduled for spring of
2007, Longley said, and will be followed by 510(k) de novo submission to FDA.
For more details see: http://media.prnewswire.com/en/jsp/latest.jsp?resourceid=3334952&access=EH
VaxGen announced that FDA has notified the biopharmaceutical company
that its second round of Phase II trials for an investigational anthrax vaccine
must be postponed. Brisbane-based VaxGen said CBER issued a “hold” notice because
the company's data is insufficient to show the product is stable enough to resume
clinical testing. In the notification, the agency expressed concerns that the
vaccine's potency could decline during the immunization phase of the trial.
VaxGen said it will meet with FDA to discuss ways to satisfy requirements and
resume testing. The company earlier won an $877.5 million contract by the U.S.
Department of Health and Human Services to provide 75 million doses of a modern
anthrax vaccine for civilian biodefense. For more details see: http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1143000&contenttype=sentryarticle&channelID=31
Trial
Briefs
Allos Therapeutics
announced the presentation of updated results from its Phase II multi-center
study of Efaproxyn (efaproxiral) in patients with unresectable non-small cell
lung cancer (NSCLC) receiving sequential chemoradiotherapy (S-CRT). Results of a five-year survival analysis
indicated that patients in the Efaproxyn study exhibited superior survival to patients with similar
characteristics in the RTOG 94-10 study. Median survival of patients treated in
the Efaproxyn study was 20.6
months as compared to a median survival of 13.3 months for matched cases in the
S-CRT arm of the RTOG 94-10 study and 16.9 months in the concurrent
chemoradiotherapy (C-CRT) arm of the RTOG 94-10 study. The Kaplan- Meier
estimates of five-year survival rates for matched cases were 19% in the Efaproxyn study and 10% in both the S-CRT and C-CRT
arms of the RTOG 94-10 study. Allos is currently conducting a Phase I study of Efaproxyn in patients with locally advanced,
unresectable (Stage III) NSCLC receiving C-CRT. Efaproxyn is the first synthetic small molecule
designed to sensitize hypoxic areas of tumors during radiation therapy by
facilitating the release of oxygen from hemoglobin and increasing the level of
oxygen in tumors, an essential element for the effectiveness of radiation
therapy. For more details see: http://media.prnewswire.com/en/jsp/latest.jsp?resourceid=3333598&access=EH
Bayer
reported findings of a new study showing that when persons with diabetes
use miscoded blood glucose meters to determine how much insulin to take,
significant errors in insulin dose can result, leading potentially to short-
and long-term health complications. The results were presented at the Sixth Annual Diabetes Technology Meeting in
http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3333413
Biopure
announced that the independent Data and Safety Monitoring Board (DSMB) for
the company's Phase II clinical trial of Hemopure [hemoglobin glutamer - 250
(bovine)] in trauma patients has completed its first scheduled interim analysis
of blinded study data and recommended that the trial continue without
modification. The DSMB reviewed
mortality and other safety data from the first 21 patients enrolled in this
single-center trial at Johannesburg Hospital Trauma Unit in
http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3334263
Boston Scientific
presented a four-year update of its key randomized, controlled clinical trials
(TAXUS II, IV, V and VI) in 3,445 patients, including 840 diabetic patients,
comparing the Taxus stent to bare-metal control stents. The diabetic patient subset
accounts for more than one-quarter of all coronary interventional procedures in
the
Callisto Pharmaceuticals
announced the first dosing of patients in a multi-center, open-label Phase II
clinical trial of Atiprimod to treat low- to intermediate-grade neuroendocrine
carcinomas, including advanced carcinoid cancers. The primary objective of the trial is to evaluate efficacy of
Atiprimod in patients with metastatic or unresectable cancer and who have
either symptoms, despite standard therapy (octreotide) or progression of
neuroendocrine tumors. Patients are required to complete two weeks of a
symptoms diary to establish their symptoms baseline before commencing Atiprimod
dosing. A maximum of 40 evaluable patients will be enrolled in this trial.
Efficacy evaluations will include the measure of target lesions (per RECIST),
and the quantization of symptom relief. Further details of this trial can be
found at www.clinicaltrials.gov For more details also see: http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3334550
CardioDynamics announced
the publication of a study in the Fall 2006 edition of the “American Heart
Hospital Journal” showing that use of impedance cardiography (ICG) was
cost-effective in both the short- and long-term when compared to standard care
treatment of patients with uncontrolled hypertension. In the previously published
CONTROL trial, use of ICG in the treatment of uncontrolled hypertension
resulted in an 8mm Hg greater systolic blood pressure reduction and a 7mm Hg
greater diastolic blood pressure reduction than standard care. The short-term
cost-effectiveness analysis demonstrated that ICG care’s incremental cost per
mm Hg reduced was $20 for systolic blood pressure (44% less than standard care's
$36 cost per mm Hg reduced) and $23 for diastolic blood pressure (71% less than
standard care's $79 cost per mm Hg reduced). The long-term cost-effectiveness
analysis showed that even if only a fraction of the short-term blood pressure
advantages with ICG were sustained, patients treated with ICG would likely
experience fewer cardiovascular events. To obtain copies of the publication,
please access the following link: http://www.lejacq.com/downloads/3rdPartyLinkOut/CrdDyn-HH5728-Ferrario.pdf
For more details see: http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3333749
Cellgate announced the initiation of a Phase II clinical trial of its lead compound, CGC-11047, a polyamine analog designed to halt cell growth and induce apoptosis. The Phase II clinical trial will enroll approximately 40 patients with metastatic hormone refractory prostate cancer who have not received prior chemotherapy. The primary endpoint for the study is efficacy based on PSA response. Safety, tolerability and time to progression will also be evaluated as part of the Phase II study. CGC-11047 will be administered intravenously as a single-agent by infusion once weekly for three weeks over a four-week cycle at a dose of 200 mg. In two separate Phase I clinical trials, a total of 20 patients (with a variety of advanced solid tumors) have been treated with CGC-11047 to date. CGC-11047 has been well tolerated with no dose-limiting toxicities reported. Preclinical in vitro studies have shown that CGC-11047 is cytotoxic to several standard tumor cell lines. For more details see:
Cordis announced that studies support the long-term
safety and efficacy of the Cypher Sirolimus-eluting coronary stent in a variety
of coronary conditions, including those with diabetes. Data from the ARTS II trial,
which compared the use of the Cypher stent to bypass surgery, showed comparable
mortality rates among diabetic patients treated with either bare metal stents
or the Cypher stent. For more details see:
http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3333259
Digene
reported that a Danish Cancer
Society study has found that for women age 40 and older, testing for
human papillomavirus (HPV) is more effective in predicting cervical cancer risk
than the traditionally used Pap smear.
The study, which followed more than 10,000 women for 10 years, was published in
the Nov. 1 issue of “Cancer Research.” Researchers used Digene’s Hybrid Capture
2 (hc2) High-Risk HPV DNA Test, the only FDA-approved test for potentially
cancer-causing types of HPV. The study
revealed that while HPV infection in younger women is more frequent, it is
usually transient, while HPV infection in women age 40 or older is less common
but more persistent, putting them at higher risk of developing abnormal cells.
As many as 21% of older women whose Pap smears were initially normal but who
were found to have HPV later developed significant abnormal cells on their
cervix. In contrast, only 1.7% of women whose HPV and Pap tests were normal
later developed abnormalities. For more details see:
http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3333505
EntreMed
announced commencement of a multi-center, Phase II clinical trial with its
clinical-stage drug candidate, Panzem NCD (2ME2 or 2-methoxyestradiol), in
patients with recurrent or resistant epithelial ovarian cancer. The Hoosier Oncology Group,
headquartered in
Hana Biosciences
announced the initiation of a multi-center Phase II clinical trial with
Talvesta (talotrexin) for injection in adult patients with relapsed or
refractory acute lymphoblastic leukemia (ALL). The primary objective of this
portion of an ongoing Phase I/II open-label study is to evaluate the complete
remission rate (CR/CRp) of Talvesta in relapsed or refractory ALL patients.
Secondary objectives are to evaluate the safety and tolerability of Talvesta in
this setting as well as duration of complete remission and overall survival.
Talvesta is a novel, nonpolyglutamable antifolate drug that targets DHFR.
Talvesta has demonstrated enhanced anti-tumor activity in a broad spectrum of
preclinical studies by targeting the enzyme DHFR to prevent DNA synthesis in
tumor cells and inhibit tumor growth. In May 2006, FDA granted orphan drug
designation for Talvesta in patients with ALL. Talvesta is also being studied
in a Phase I trial in solid tumors and a Phase I/II trial in non-small cell
lung cancer (NSCLC). For more details see:
http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1134367&contenttype=sentryarticle&channelID=28
ImClone Systems and Bristol-Myers Squibb reported mixed results from a pair of randomized Phase III trials of Erbitux (cetuximab) in 572 patients with metastatic colorectal cancer. A randomized, multi-center, Phase III trial of Erbitux and best supportive care versus best supportive care alone met its primary efficacy endpoint by showing a statistically significant improvement in overall survival in metastatic colorectal cancer whose disease was refractory to all available chemotherapy. But a second Phase III trial of Erbitux plus irinotecan versus irinotecan alone did not meet its primary endpoint of overall survival, though secondary endpoints of progression-free survival and response rate “strongly favored” the Erbitux combination. The study was conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) in collaboration with the Australasian Gastro-Intestinal Trials Group (AGITG). A second Phase III, randomized study, known as the Erbitux Plus Irinotecan in Colorectal Cancer (EPIC), compared irinotecan to irinotecan plus Erbitux in approximately 1,300 patients whose disease was not responding to first-line oxaliplatin-based chemotherapy. Secondary efficacy endpoints (progression free survival, response rate) strongly favored the combination of Erbitux plus irinotecan over irinotecan alone; however, the primary endpoint (overall survival) was not met. Efforts to interpret these confounded results are ongoing. For more details see:
Infinity Pharmaceuticals
announced preliminary results from an open-label Phase I clinical study of
IPI-504 in patients with Gleevec-resistant metastatic gastrointestinal stromal
tumors (GIST). IPI-504, Infinity's lead
oncology drug candidate, is a proprietary small molecule inhibitor of Heat
Shock Protein 90 (Hsp90) that is being jointly developed by Infinity and MedImmune. This trial is being
conducted at the Dana-Farber Cancer
Institute in
Kaiser Permanente reported that its
study of 24,600 patients in
Karolinska Institute in Stockholm announced that a study of seven years of patient data in
the United Kingdom general practice database indicates that the use of drugs
that reduce stomach acid, such as H2 blockers (Zantac, Tagamet) and proton pump
inhibitors (Prilosec), do not increase the risk of cancer of the esophagus or
stomach. The study reported was reported in the November 2006 issue of the
journal “Gut.” The research team compared 287 patients with esophageal cancer
and 522 with stomach cancer with 10,000 randomly selected subjects without
cancer. The authors found some conditions such as acid reflux disease, hiatal
hernia and Barrett’s esophagus were associated with an increased risk of
stomach and esophagus cancer. However, no apparent cancer risk was seen with
other conditions, including peptic ulcer, gastritis and indigestion. They found
no evidence that the drugs themselves increased the risk. For more details see:
Maxygen
announced that Roche has initiated a Phase Ia clinical trial in New
Zealand to evaluate the safety, tolerability, pharmacokinetic and
pharmacodynamic profile of Maxy-alpha, a next-generation interferon alpha for
the treatment of hepatitis C virus infection. The trial is a double-blind, dose-escalation, controlled study of a
single subcutaneous administration of Maxy-alpha in healthy volunteers with
both placebo and Pegasys (peginterferon alfa-2a (40KD)) control groups.
Maxy-alpha, also known as R7025, is a novel PEGylated interferon alpha variant
created through the use of Maxygen's proprietary MolecularBreeding directed
molecular evolution technologies. Maxy-alpha has been designed to have more
anti-viral activity against the hepatitis C virus and be more effective in
stimulating immune responses to help combat the infection. For more details
see:
http://media.prnewswire.com/en/jsp/latest.jsp?beat=BEAT_HEALTHCARE&view=LATEST&resourceid=3334295
MedImmune announced preliminary results from a Phase III pivotal study showing that Numax met its primary endpoint of non-inferiority by reducing the incidence of hospitalizations caused by respiratory syncytial virus (RSV) in infants at high risk for serious RSV disease by 26% when compared to Synagis (palivizumab). The data also indicate that Numax showed superiority over Synagis in a secondary endpoint by reducing the incidence of RSV-specific medically attended outpatient lower respiratory infections (LRI) by approximately