New Publications Form The BDA

The British Dental Association (BDA) has published three new books: Treatment Planning in Implant Dentistry; Lasers in Dentistry; and The Internet Guide for Dentistry.

Treatment Planning in Implant Dentistry has been developed from a series commissioned for the British Dental Journal to provide a systematic approach to decision making prior to implant placement. Authored by Sajid Jivraj, a private practitioner in California, and Winston Chee, Professor of Restorative Dentistry and Director of Implant Dentistry at the University of California School of Dentistry, the book covers subjects including surgical guidance for implant placement, impression techniques and failures in implant dentistry.

Lasers in Dentistry serves as an introduction to lasers as well as outlining their many uses in dentistry. The title considers subjects including ‘fixed’ and ‘loose’ soft tissue surgery, lasers in implantology and endodontics and laser regulation and safety in general dental practice. Written by Steven Parker, a GDP who has been using lasers since 1990, the book offers a practical guide to their utilisation in modern dentistry.

The Internet Guide for Dentistry is a practical reference to the internet that offers a solid introduction to the world wide web and email as well as providing guidance on creating a website for a dental practice and profiling the dental resources available online. Written by practising GDP Paul Downes, this title is designed to appeal to both the internet novice and the more seasoned browser.

Stephen Hancocks, Editor-in-Chief of the British Dental Journal, said:

“These are three exciting additions to the range of BDJ Books. Dentistry is constantly changing. These titles will help practitioners keep up to date with the latest technologies and techniques affecting the way they work.”

The books are all published in paperback and cost ??48.75 each. BDA members pay just ??38.95 per title. All are now available via the BDA shop at bda/bdashop/.

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World’s Mental Health Care Needs Not Being Met, Global Survey Finds

Mental disorders rank among the top ten illnesses causing disability — more than 37 percent worldwide — with depression being the leading cause of disability among people ages 15 and older, according to the Global Burden of Disease and Risk Factors published in 2006. Yet, the world’s mental health care needs are largely going unmet, especially in less developed nations but also in high-income countries, according to results from a new survey of 17 countries conducted as part of the World Health Organization’s (WHO) World Mental Health Survey Initiative. The results of the initiative, partially funded by the National Institutes of Health’s National Institute of Mental Health (NIMH), were published in The Lancet September 2007.

“Good treatments are available for many mental disorders. Yet, the world continues to struggle with the very real challenge of providing these services to the people who most need them,” said NIMH Director Thomas R. Insel. “The WHO survey unmistakably reinforces the urgency that we must do better.”

Philip S. Wang, M.D., Dr.P.H., currently director of the NIMH Division of Services and Intervention Research, and colleagues analyzed data from face-to-face interviews on mental health service use with 84,848 adults across all economic spectrums in countries around the world. Respondents were asked about anxiety, post-traumatic stress, mood, and substance abuse disorders. They were also asked if they received any services in the past year for mental disorders; and if so, what types of services they had used, such as general medical professional, mental health professional, religious counselors or traditional healers.

The survey found that mental health service use varied significantly among the 17 countries. Overall, fewer people in less developed countries with mental disorders sought services compared with people in developed countries. In addition, the survey found that people in countries spending more of their gross national product (GDP) on health care used services more often. The U.S. population used services more than any other country, at 18 percent. By comparison, 11 percent of France’s population used services. The lowest rate of services use was 1.6 percent in Nigeria.

In all countries surveyed, women were more likely than men to seek mental health services. Additional results of countries surveyed found that,

* middle-aged people were more likely to receive services than those younger or older;

* people with more education were more likely to seek out services for mental problems; and

* married people were less likely to use mental health services than unmarried people

Most of those who sought care for mental disorders received help from the general medical sector (primary care doctors, nurses) rather than specialized mental health services (psychiatrists, psychologists), religious or community counselors, or complementary and alternative medicine providers (including traditional healers). Among those receiving services, a substantial number of survey respondents reported that they did not receive minimally adequate services. The survey defines minimally adequate services as at least eight visits to any service sector, or being in ongoing treatment at the time of the interview, or receiving a medication for at least one month with four or more visits to a medical professional over a 12-month period.

Inadequate services were most commonly found in low-income countries, but even in some high-income countries, people received inadequate services. For example, in the United States, only 18 percent received minimally adequate services — much lower than any other high-income country. The next lowest level of minimally adequate services in a high-income country was 32 percent, in Japan. France and Germany had the highest level of adequate services, at 43 percent each.

“Although people sought and used services more in the United States, most did not receive adequate care — evidence of a striking disconnect in the U.S. mental health care system,” said Dr. Wang, who conducted the research while he was at Harvard University. “We need to help developing countries implement more effective mental health care services, but we also need to do a better job at home. The global mental health care situation appears dire,” concluded Dr. Wang.

The National Institute of Mental Health (NIMH) mission is to reduce the burden of mental and behavioral disorders through research on mind, brain, and behavior. More information is available at the NIMH website, nimh.nih/.

The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nimh.nih/.

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Memory Loss, Safety And Confusion Top Alzheimer’s Caregivers’ Concerns, National Survey Reveals

Caregivers and loved ones of individuals with Alzheimer’s disease are most concerned about the patients personal safety, loss of memory and confusion – memory loss and confusion are examples of cognitive symptoms, which worried over two-thirds of caregivers the most, according to a national survey of non-professional caregivers involving 524 participants. The Harris Interactive Survey was carried out last month on behalf of AFA (Alzheimer’s Foundation of America), Eisai Inc., and Pfizer (the last two being pharmaceutical companies).

Eric J. Hall, president and CEO of AFA, said:

These survey results reveal the changes in cognition as the disease progresses were an important concern among caregivers. We encourage caregivers and health care professionals to discuss these changes and any others during regular visits.

Alzheimer’s disease is a progressive neurologic brain disease which eventually leads to permanent loss of neurons and cognitive/intellectual abilities, including reasoning and memory. As the disease progresses the patient’s abilities to function socially or occupationally become so undermined that they need to be looked after. Typically, there are three stages to the disease – mild, moderate and severe. Caregivers and doctors often need to consult regarding the patient’s lifestyle and treatment options.

The survey revealed that approximately three-quarters of caregivers are either “satisfied” or “very satisfied” with the therapy provided by health care professionals for their loved one. The rest of respondents who rated this as either “not at all satisfied” or “somewhat satisfied” reveal a need for improvement, the survey authors wrote.

Barry W. Rovner, M.D., director of the Division of Geriatric Psychiatry and professor in the departments of Neurology and Psychiatry at Thomas Jefferson University , Philadelphia, said:

AD (Alzheimer’s disease) caregivers are typically the first to notice when their loved one’s symptoms are becoming worse and whether the disease may be progressing to the next stage, which is why caregivers are essential partners in disease management discussions. In the face of this devastating chronic and progressive disease, it is important for AD caregivers to know about the available educational resources, support networks and treatments in order to enhance these discussions at all stages of the disease.

The survey revealed some of the problems caregivers have to cope with, as well as concerns and worries about how the disease progresses and is expected to progress, and discussions with health care professionals. 173 males and 351 female caregivers contributed towards the survey. There were some differences in priorities reported by male and female caregivers.

Highlighted below are some of the difficulties caregivers have to cope with:

55% say their caregiving duties have had a negative impact on their own health
13% of female caregivers tended to worry all the time, compared to just 3% of the male ones
60% of them said the whole thing was overwhelming
47% of female caregivers found maintaining relationships with friends and family “challenging”, compared to 31% of men
67% of caregivers of mild AD patients found their duties often stopped them from taking part in activities they liked, compared to 68% of those with a moderate AD patient and 84% of those caring for a loved one with severe AD.

Highlighted below are some of the worries caregivers have about the progression of Alzheimer’s disease:

Caregivers worried the most about: 41% memory loss, 33% personal safety, 27% confusion.
67% mentioned at least one cognitive ability loss as their main worry when thinking about AD’s progression
50% of male caregivers were concerned and worried about memory loss, compare to 37% of the female ones

Highlighted below are some of the survey results regarding caregivers’ dealings and discussions with health care professionals:

84% of male caregivers were satisfied with their health care professional communications versus 70% of the females ones
26% of males asked the doctor about support information, compared to 14% of females
53% of all caregivers who were not very involved in liaising with a health care professional were not satisfied with their loved one’s treatment
31% of all caregivers who were very involved in liaising with a health care professional were not satisfied with their loved one’s treatment Continue reading

PTC Therapeutics Announces Encouraging Preliminary Phase 2 Results Of PTC124 In Duchenne Muscular Dystrophy

PTC Therapeutics, Inc.
(PTC), a biopharmaceutical company focused on the discovery and development
of small-molecule drugs targeting post-transcriptional control processes,
today announced encouraging data from a Phase 2 clinical trial of PTC124 in
patients with Duchenne muscular dystrophy (DMD) due to a nonsense mutation.
The results imply pharmacological activity based on preliminary data that
suggest increases in dystrophin in muscle biopsies in a number of patients
and statistically significant improvements in muscle enzymes in serum. The
preliminary data were presented today at the PPUK 4th International DMD
Conference in London, England.

“These results are the first example of an oral therapy addressing the
underlying cause of DMD by restoring dystrophin production,” said Dr.
Richard Finkel, Director of the Neuromuscular Program, Children’s Hospital
of Philadelphia, PA, one of the trial’s lead investigators. “There are
limited therapeutic options for patients living with DMD, and these data
strongly indicate PTC124 warrants further clinical investigation in this
patient population, which has a great unmet medical need.”

Langdon Miller, M.D., Chief Medical Officer, PTC, stated, “These
preliminary results in patients with DMD provide confirmation of proof of
concept that PTC124 can induce ribosomal readthrough of nonsense mutations
as an approach to treating genetic disorders. Given that PTC124 was very
well- tolerated and activity was observed at lower-than-expected plasma
concentrations, we are amending this trial to evaluate higher dose levels
and the potential to further increase dystrophin expression.”

“In the first half of 2007, we expect to present the final data set
from this Phase 2 clinical trial and meet with regulatory authorities to
determine the next steps for further clinical development of PTC124.
Following these discussions, we hope to initiate longer-term clinical
trials for PTC124 in 2007,” said Dr. Miller.

Patients with DMD lack dystrophin, a protein that is critical to the
structural stability of muscle fibers. This Phase 2 multi-site, open-label,
dose-ranging clinical trial is evaluating muscle dystrophin expression in
patients with nonsense-mutation-mediated DMD. Blood levels of
muscle-derived creatine kinase are being measured as assessments of muscle
integrity. PTC124 safety, compliance, and pharmacokinetics are also being
evaluated.

Patients included in the interim analysis were enrolled at three
clinical sites in the United States: Children’s Hospital of Philadelphia,
Philadelphia, Pennsylvania; Cincinnati Children’s Hospital Medical Center,
Cincinnati, Ohio; and the University of Utah, Salt Lake City, Utah. In the
study, patients received 28 days of PTC124 treatment at one of two dose
levels. All patients were boys with a nonsense mutation in the dystrophin
gene, substantially elevated serum creatine kinase, and symptoms associated
with DMD.

Assessment of the in vitro effects of PTC124 on dystrophin expression
showed dose-dependent production of full-length dystrophin in myocytes
obtained from multiple study subjects; these data suggest the potential for
response across a range of early to late nonsense mutations within the
dystrophin gene. Evaluation of the in vivo effects of PTC124 over the
28-day treatment course suggest an increase in dystrophin expression in
muscle biopsies in a number of the boys participating in the trial,
although quantitative analysis is not yet complete. Statistically
significant reductions in the concentrations of muscle-derived creatine
kinase levels in the blood were observed during PTC124 treatment. Although
no formal questionnaire was used to collect data on changes in DMD-related
symptoms, several parents and teachers reported that boys participating in
the study had improvements in terms of greater activity level and increased
endurance during treatment.

PTC124 was well tolerated among the 26 patients included in the study.
Potentially drug-related adverse events were infrequent, mild to moderate
in severity, did not result in therapy interruptions or discontinuations,
and were reversible. There were no safety concerns based on physical
examinations, vital sign measurements, electrocardiograms, or laboratory
parameters. Compliance was excellent at both dose levels.

“These preliminary results are very encouraging and add to the growing
body of clinical evidence supporting the potential of PTC124 as a treatment
for genetic disorders due to a nonsense mutation,” said Stuart W. Peltz,
Ph.D., President and Chief Executive Officer of PTC Therapeutics. “The
findings in the DMD trials are consistent with the results observed in
Phase 2 clinical trials of PTC124 in patients with cystic fibrosis. We
intend to extend this concept into other nonsense-mediated genetic
disorders.”

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a progressive muscle disorder that
causes the loss of both muscle function and independence. DMD is perhaps
the most prevalent of the muscular dystrophies and is the most common
lethal genetic disorder diagnosed during childhood today. Each year,
approximately 20,000 children worldwide are born with DMD (one of every
3,500 male children). More information regarding DMD is available through
the Muscular Dystrophy Association (mdausa) and the Parent
Project Muscular Dystrophy (parentprojectmd).

About PTC124

PTC124 is an orally delivered product candidate in Phase 2 clinical
development for the treatment of genetic disorders due to nonsense
mutations. Nonsense mutations are single-point alterations in the genetic
code that prematurely halt the translation process, producing a shortened,
non- functional protein. PTC124 has demonstrated activity in preclinical
genetic disease models harboring nonsense mutations allowing the
restoration of the production of full-length, functional proteins. In Phase
1 clinical trials, PTC124 was generally well tolerated, achieved target
plasma concentrations that have been associated with activity in
preclinical models, and did not induce ribosomal readthrough of normal stop
codons. PTC is currently conducting Phase 2 clinical trials of PTC124 in
nonsense-mutation-mediated cystic fibrosis (CF) and Duchenne muscular
dystrophy (DMD).

It is estimated that 10% of the cases of CF and 13% of the cases of DMD
are due to nonsense mutations. PTC believes that PTC124 is potentially
applicable to a broad range of other genetic disorders in which a nonsense
mutation is the cause of the disease. The FDA has granted PTC124 Fast-Track
designations and Orphan Drug designations for the treatment of CF and DMD
due to nonsense mutations. PTC124 has also been granted orphan drug status
for the treatment of CF and DMD by the Committee for Orphan Medicinal
Products (COMP) of the European Medicines Agency (EMEA). PTC124′s
development is supported by grants from the Muscular Dystrophy Association
(MDA), Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), Parent Project
Muscular Dystrophy (PPMD), FDA’s Office of Orphan Products Development
(OOPD), and by General Clinical Research Center grants from the National
Center for Research Resources (NCRR).

About PTC Therapeutics, Inc.

PTC is a biopharmaceutical company focused on the discovery and
development of orally administered, proprietary small-molecule drugs that
target post-transcriptional control processes. Post-transcriptional control
processes regulate the rate and timing of protein production and are of
central importance to proper cellular function. PTC has assembled
proprietary technologies and extensive knowledge of post-transcriptional
control processes that it applies in its drug discovery and development
activities. PTC’s current pipeline of clinical and preclinical product
candidates addresses multiple indications, including genetic disorders,
oncology, and infectious diseases.

PTC Therapeutics, Inc

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Largest Ever Clinical Trial On Stroke Recovery Medication To Be Initiated In Singapore And Philippines

NeuroAid™, a Traditional Chinese Medicine (TCM) to aid stroke recovery, is set to undergo the largest clinical trial ever conducted on a stroke recovery medication. The trial targets stroke patients, who will be recruited within 48 hours of stroke incidence at participating hospitals.

The study will be carried out by the CHIMES Society, a non-profit multinational academic society comprising doctors and stroke specialists, which aims to study the efficacy of NeuroAid™ on stroke recovery at acute stage. Members include renowned neurologists from Europe and Asia. This trial will roll out progressively at several hospitals beginning in Singapore in October 2007.

The CHIMES Stroke Study is ground-breaking for the medical industry as the largest clinical trial on stroke recovery and the first time any TCM product has been assessed on this wide a scale outside China. The two-year study is a unique collaboration between stroke centres across Southeast Asia, including the University of Santo Tomas hospital in the Philippines, and a number of leading hospitals in Thailand.

In Singapore the study is supported by a grant from the National Medical Research Council (NRMC).

Professor Marie-Germaine Bousser, Head of Neurology at Lariboisiere Hospital in Paris, France, and Vice Chairman of the CHIMES society, commented, “Recent drug trials in the acute treatment of stroke have unfortunately all been negative. It is thus very exciting to take a completely new approach and to scientifically test in different populations a compound that has long been used in TCM.”

David Picard, CEO of Moleac, the Singapore-based biopharmaceutical company that develops and markets NeuroAid™ outside of China, said, “We are delighted at the interest NeuroAid™ has generated among the medical community worldwide. Over 200,000 patients in China are using NeuroAid™ every year, and we get positive feedback from individual patients internationally. Nevertheless we still need to generate accepted Western data from the early stages of stroke to further validate its use, and to encourage the international medical community at large to prescribe it to their patients.

“Our ultimate goal is to see NeuroAid™ established within accepted treatment guidelines for stroke sufferers, making its benefits available to all patients who need it,” he added.

NeuroAid™ is marketed internationally by Moleac, which identified the product in China as the first medicine that can help bring about faster and fuller recovery of motor and cognitive functions in stroke patients during rehabilitation. It is available in Singapore as a Chinese proprietary medicine, and in other countries in the region as a food supplement. Doctors and patients from as far as the United States have also started using NeuroAid™ regularly with positive results.

More information about the CHIMES study can be obtained at chimes-society.

About NeuroAidTM

NeuroAid™ is a Traditional Chinese Medicine (TCM) product first developed in China. Targeting stroke patients, it helps patients achieve better recovery of motor and cognitive functions. It is a combination of fourteen all-natural ingredients from the Chinese medicinal pharmacopoeia, formulated according to international Good Manufacturing Practice (GMP) standards.

NeuroAid™’s efficacy and safety was tested in a multi-centre double blind randomized clinical trial conducted on 605 patients in China from 1999-2000. Patients taking NeuroAid™ were shown to be 2.11 times more likely to reach functional independence and 1.7 times more likely to reduce their neurological deficit of at least 55% than patients who did not take the product. It helped improve stroke patients’ ability to recover even when treatment was started several weeks after the onset of stroke.

NeuroAid™ is currently marketed in Singapore as a Chinese proprietary medicine to support neurological functions, and in other countries as a food supplement or a natural medicine. It is also sold internationally by Moleac via the website neuroaid. With the CHIMES study under way, it is the first traditional medicine in the world to undergo a large scale evidence-based medical trial.

About Chimes Society

CHIMES is a Singapore-based non profit society formed by a group of key international opinion leaders in stroke, Southeast Asia regional experts and clinicians.

The society was founded to implement a clinical trial on NeuroAid™’s efficacy in aiding stroke recovery. Conducted in compliance with standard Western clinical trial methodology, the study represents an innovation in bridging Eastern and Western medicine.

The CHIMES study, a multi-centre double blind controlled randomised trial, will compare NeuroAid™ with a matched placebo in its ability to reduce neurological deficit and improving independence in patients who have suffered from a moderately severe stroke. It will recruit 1,100 participants. These patients will be recruited within 48 hours after suffering a stroke attack, and will be periodically assessed for three months.

In 2007, CHIMES received a landmark study grant in 2007 from the Singapore National Medical Research Council. The trial will begin in October 2007, at sites in Singapore and in the Philippines. In the ensuing months, leading hospitals in Thailand will also join the trial.

For more information on CHIMES, please visit chimes-society.

About Moleac

Moleac is a biopharmaceutical company that brings together the best of Asian and Western medicinal traditions. It identifies promising medicine discovered in China and develops them into Western mainstream medicine. Conversely, it develops and markets in Asia innovative technologies and medical products that it in-licenses from Europe.

Its first drug, NeuroAid™, focuses on brain stroke recovery and is derived from Traditional Chinese Medicine (TCM). NeuroAid™ is sold in Singapore, Philippines, Thailand, South Africa and China, and is also available worldwide via neuroaid, and Moleac’s website, moleac

Moleac is headquartered in Singapore. Its operations and research are located in Biopolis, a world-class purpose built complex for biomedical sciences research.

biopolis.sg
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TRACON Pharmaceuticals And Micromet Announce The Initiation Of Phase 1 Clinical Trial With TRC093 (D93), A Humanized Antibody For Cancer Treatment

TRACON
Pharmaceuticals, Inc. (TRACON), a biopharmaceutical company focused on the
development of products for oncology and ophthalmology treatment, and
Micromet, Inc., (Nasdaq: MITI), a biopharmaceutical company focused on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases, announced today that TRACON has
started the treatment of the first cancer patient in a Phase 1 clinical
trial with TRC093.

TRC093 is a first-in-class humanized monoclonal antibody that inhibits
angiogenesis and tumor cell growth by binding cleaved collagen, a component
of the extracellular matrix of tumors that serves as the scaffold for new
blood vessel and tumor growth. TRC093 has shown activity, as monotherapy or
when combined with chemotherapy, in pre-clinical studies of melanoma,
breast and pancreatic cancer.

TRC093 is currently being developed by TRACON in oncology and
Age-Related Macular Degeneration (AMD), following execution of a license
agreement with Micromet, Inc. in March 2007, granting TRACON worldwide
rights to develop and commercialize D93 (now TRC093). TRC093 (D93) was
generated and developed by Micromet up to the filing and acceptance of the
IND.

“TRACON’s management team is cohesive and focused on execution. These
qualities, combined with our excellent working relationship with Micromet
and top-notch Phase 1 sites, have allowed us to initiate dosing within four
months of execution of the license agreement,” said Charles Theuer, M.D.,
Ph.D., President and Chief Executive Officer of TRACON Pharmaceuticals,
Inc. “Moving a humanized antibody into the clinic, that has the potential
to treat multiple solid tumors in combination with chemotherapy and
targeted agents, is a major milestone for TRACON in what will be a busy
year for the company. We anticipate dosing two additional first-in-class
cancer treatments later this year.”

The Phase 1 trial is designed to assess the safety, tolerability and
pharmacokinetics, as well as preliminary anti-tumor activity, of TRC093 in
patients with advanced cancer.

“We are very pleased to see that TRACON has initiated a broad
development program very shortly after receiving the license from us in
March of this year. The initiation of the Phase 1 study is an important
milestone for the product and we are looking forward to the expansion of
the program into age- related macular degeneration,” said Jens Hennecke,
Vice President Business Development of Micromet.

About TRACON Pharmaceuticals

TRACON Pharmaceuticals (traconpharma) is a privately held
biopharmaceutical company focused on the development of products for
oncology and ophthalmology treatment, including agents that inhibit
angiogenesis. TRACON addresses unmet needs in these areas with
first-in-class product candidates that will complement existing therapies.
TRC093 is a monoclonal antibody that binds to cleaved collagen to inhibit
angiogenesis and tumor growth. TRC105 is a monoclonal antibody that binds
CD105 to inhibit angiogenesis (IND expected in 2007). TRC102 is a small
molecule that reverses resistance to chemotherapeutics that is currently
being evaluated in a Phase 1 trial and TRC101 is a nanoliposome embedded
with ceramide used to improve the activity and delivery of
chemotherapeutics. TRACON Pharmaceuticals was founded by Paramount
BioSciences, LLC.

About Paramount BioSciences

Paramount BioSciences, LLC is a global drug development and healthcare
investment firm that conceives, nurtures, and supports new biotechnology
and life-sciences companies. For additional information about Paramount
BioSciences, visit paramountbio.

About Micromet Inc.

Micromet, Inc. is a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases. Three product candidates are
currently in clinical trials. MT103/MEDI-538, which is the first product
candidate based on Micromet’s novel BiTE(R) product development platform,
is being evaluated in a phase 1 clinical trial for the treatment of
patients with non-Hodgkin’s lymphoma. The BiTE product development platform
is based on a unique, antibody-based format that leverages the cytotoxic
potential of T cells, widely recognized as the most powerful ‘killer cells’
of the human immune system. Adecatumumab (MT201), a recombinant human
monoclonal antibody which targets EpCAM expressing tumors, has completed
two phase 2a clinical trials, one in patients with breast cancer, which has
shown activity in patients with high EpCAM expression, and the other in
patients with prostate cancer. In addition, a phase 1b trial evaluating the
safety and tolerability of MT201 in combination with docetaxel is currently
ongoing in patients with metastatic breast cancer. Micromet has established
collaborations with MedImmune, Inc. for MT103/MEDI-538 and Merck Serono for
adecatumumab (MT201). Our third clinical stage product candidate is D93,
also known as TRC093, a first-in- class humanized monoclonal antibody that
inhibits angiogenesis and tumor cell growth by binding cleaved collagen, is
being developed by TRACON Pharmaceuticals, Inc. in oncology and Age-Related
Macular Degeneration (AMD) pursuant to a license agreement under which we
have granted TRACON worldwide rights to develop and commercialize
D93/TRC093. In addition, Micromet has established a collaboration with
Nycomed for the development and commercialization of MT203, Micromet’s
human antibody neutralizing the activity of GM-CSF, which may be important
in the treatment of inflammatory diseases, such as rheumatoid arthritis.

Forward-Looking Statements

This release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be materially
different from historical results or from any future results expressed or
implied by such forward-looking statements. Such forward-looking statements
include statements regarding the observation of activity of D93/TRC093 in
preclinical studies, and the company’s and TRACON Pharmaceutical Inc.’s
current and planned clinical development activities. Factors that may cause
actual results to differ materially from any future results expressed or
implied by any forward-looking statements include the risk that product
candidates that appeared promising in early research, preclinical studies
or clinical trials do not demonstrate safety and/or efficacy in subsequent
clinical trials, the risk that encouraging results from early research,
preclinical studies or clinical trials may not be confirmed upon further
analysis of the detailed results of such research, preclinical study or
clinical trial, the risk that additional information relating to the
safety, efficacy or tolerability of our product candidates may be
discovered upon further analysis of preclinical or clinical trial data, the
risk that we or our collaboration partners will not obtain approval to
market our product candidates, the risks associated with reliance on
outside financing to meet capital requirements, and the risks associated
with reliance on collaboration partners, including MedImmune, Merck Serono
and Nycomed, for the funding or conduct of further development and
commercialization activities relating to our product candidates. You are
urged to consider statements that include the words “ongoing”, “may”,
“will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”,
“potential”, “expects”, “suggests”, “plans”, “anticipates”, “intends”,
“continues”, “forecast”, “designed”, “goal”, or the negative of those words
or other comparable words to be uncertain and forward- looking. These
factors and others are more fully discussed in our periodic reports and
other filings with the SEC.

Any forward-looking statements are made pursuant to Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, and, as such, speak only as of the date
made. Micromet, Inc. undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information, future
events or otherwise.

Micromet, Inc.
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New Data Confirm Efficacy And Favourable Safety Profile Of Resolor(R) For Patients With Severe Chronic Constipation

New data presented at the United European Gastroenterology
Week (UEGW) confirm the efficacy and safety of prucalopride, a novel
enterokinetic compound, in patients with chronic constipation for whom
laxatives do not provide adequate relief.

Prucalopride was evaluated in a large double-blind (n=231),
placebo-controlled, phase II dose-finding trial (USA-3) that supports the
choice of 2 mg as the lowest effective dose. Both the 2 mg and 4 mg dosing of
prucalopride were superior to the 0.5 mg and 1 mg dosing with 4 mg showing a
marginal benefit over 2 mg but a less favourable AE profile. There was no
rebound effect during the run-out phase. Prucalopride was well tolerated at
all doses tested.

In a phase III trial (USA-28) aimed at studying the effects of
retreatment with prucalopride, the product demonstrated rapid and sustained
symptom relief in patients with chronic constipation. The efficacy findings
during 4 weeks of treatment were comparable to those during 4 weeks of
re-treatment. It was also shown that episodic use of 4 mg prucalopride was
well tolerated.

From a safety perspective, prucalopride is well tolerated at
repeated doses up to 5 times the anticipated therapeutic dose for treatment
of chronic constipation. In a randomized, double-blind, placebo-controlled,
cross-over trial (GBR-9) focusing on cardiovascular safety of prucalopride in
healthy subjects, no significant difference versus placebo was noted on a
variety of CV parameters including BP, QT and HR.

Furthermore, at UEGW, data from a small double-blind,
placebo-controlled, cross-over trial (GBR-7) to evaluate the effects of
prucalopride in patients with chronic intestinal pseudo-obstruction (CIP) due
to visceral myopathy or neuropathy, were presented that demonstrated the
favourable effect prucalopride had a on pain, nausea, vomiting, bloating and
analgesic intake.

The pharmacokinetic (PK) profile of prucalopride was
documented in a trial involving male and female subjects. The product has a
predictable PK profile and can be taken with or without meals. Its half-life
allows for once daily (o.d.) dosing. Prucalopride has a low potential for
metabolic drug-drug interactions, including CYP 450 iso-systems. This further
confirms the wide safety margin of the product.

. Dirk Reyn, CEO of Movetis, commented: “We are pleased with
the presentation of these data at UEGW because it reinforces the strength of
our dataset after recent publications in peer reviewed journals like the New
England Journal of Medicine (NEJM).” Lieve Vandeplassche, VP late clinical
development for Resolor at Movetis continues: “There is a serious unmet need
for a well tolerated, efficacious treatment for chronic constipation. For
years, the impact of chronic constipation has been underestimated and
research relating to this condition has been much less than in other medical
areas. In Europe alone, approximately 10 million patients visit their doctors
seeking help after unsatisfactory results with over-the-counter medications.
We hope that prucalopride will help to improve the lives of these patients
both in Europe and worldwide.”

About prucalopride

Prucalopride is a novel enterokinetic treatment, and the first
compound in a new generation of selective, high-affinity 5-HT4 receptor
agonists, specifically designed to restore impaired bowel motility and help
patients with chronic constipation for whom laxatives do not provide adequate
relief. By direct action on the wall of the gut, prucalopride offers a novel
approach to a debilitating disease. Prucalopride has completed three
identically designed Phase III studies and has been tested in more than 3,000
patients. Movetis filed for marketing approval in May 2008 in Europe and is
currently under review by the EMEA and Swissmedic.

About chronic constipation

Chronic constipation is a general disorder of the
gastrointestinal tract that affects an estimated 80 million people worldwide
and at least 37 million in Europe(1). It is a prevalent and debilitating
condition with a clear impact on quality of life. The ROME III guidelines
define chronic constipation as two or more of the following symptoms at least
a quarter of the time for at least six months: straining, lumpy or hard
stools, a sensation of incomplete evacuation, a sensation of anorectal
obstruction or blockage, and/or less than 3 defecations per week(2). In many
cases available prescription or over the counter drugs, offer inadequate
treatment. There is need for an alternative and novel approach to help
chronic constipation patients.

About Movetis

Through a clear focus on gastroenterology (GI), Movetis seeks
to improve the lives of millions of patients – both adults and children – by
discovering, developing and ultimately commercializing innovative treatments
targeting GI conditions with a high unmet medical need. Movetis NV – founded
in Belgium in December 2006 – aims to become a leading European specialty
pharmaceutical organization focused on GI diseases. Movetis has a broad GI
portfolio with one product for which the marketing application was filed, two
products in clinical development, one product ready to move into clinical
development and four in preclinical, all addressing important GI areas
including chronic constipation, ascites, paediatric reflux in infants,
diabetic gastroparesis, specific subgroups of patients with severe forms of
irritable bowel syndrome or dyspepsia. In addition, Movetis has rights to a
large library of qualified lead compounds with potential for development in
different GI indications and access to know how for compounds in secretory
diarrhoea. The current portfolio has been licensed from Janssen Pharmaceutica
NV, Belgium and Ortho-McNeil Pharmaceutical Inc., two Johnson & Johnson (J&J)
companies.

The current portfolio includes:

– Prucalopride, which has completed clinical development for
chronic constipation and has been filed with the EMEA and Swiss health
authorities.

– M0002 is in Phase II clinical development for ascites

– M0003 is in clinical development for gastroparesis and
paediatric reflux.

– M0004 is ready to go into clinical development for refractory GORD
and/or non erosive reflux disease (NERD);

– four compounds in preclinical development;

– two compound libraries, each with more than 600 ligands.

(1) Reyn. D. Opportunities in gastroenterology. Drug Discovery World -
Winter 2007/8.

(2) Drossman (2006) Rome III: The new criteria. Chinese Journal of
Digestive Diseases 7 (4) , 181-185

Source
Ingrid Jansen
Movetis NV
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Modulated Radiotherapy Can Cut Treatment Time For Cancer Of The Rectum Without Increasing Toxicity

Application of modulated radiotherapy in the treatment of bowel cancer can enhance the results obtained by means of other conventional therapies. The technique has managed to apply the radiation in a way most adapted to the tumoral volume and risk areas, while minimising irradiation to healthy tissue. This radiotherapy procedure involves the administration of higher daily doses of radiation but with a total dose equivalent to conventional ones. In this way the treatment time is cut by 30%, without a rise in side effects and with very high rates of pathological response.

These were the results of the study undertaken by a team of doctors at the University Hospital of Navarra, recently published in the specialist scientific journal, nternational Journal of Radiation Oncology, Biology, Physics of the American Society for Therapeutic Radiotherapy and Oncology. Involved in the research was a medical team from the area of digestive system tumours, led by Doctor Jos?© Javier Aristu, specialist at the Oncological Radiology Service. The article in the North American journal is the first published in the world giving clinical results from the application of preoperational modulated radiotherapy in tumours of the rectum.

Novelty for cancer of the rectum

IMRT (Intensity-Modulated Radiation Therapy) is a radiotherapy technique in which the administration of the radiation doses for the patient is effected by means of a lineal accelerator equipped with a system of multilaminas. Depending on the characteristics of the region that has to be irradiated, the planning system is capable of adapting high radiation doses to the shape of the target volume, enabling adjustments to be made to the morphology of the area to be treated in an individualized manner.

To date, the application of this procedure had been fundamentally limited to tumours located in the head, neck and prostrate gland. “This technique had been used in more confined tumours, more limited and smaller. We have now also begun to apply it to tumours of the rectum given that the conventional treatment, combining chemotherapy and radiotherapy, may cause high levels of toxicity”, explained Doctor Aristu.

The main goal in administering modulated radiotherapy in the treatment of cancer of the rectum, lies in excluding the greatest possible proportion of healthy tissue from the field of radiation, mainly the intestines, bladder and the healthy section of the rectum. We have shown that treatment using conventional radiotherapy and chemotherapy simultaneously causes about a 30% enteritis rate (inflammation of the intestine). However, in the study, we observed that the application of modulated radiotherapy reduces the rate of enteritis practically to the minimum in the patient who is being treated for bowel cancer. Moreover, on limiting the radiation to the tumoral mass and thus affecting healthy tissue less, it was possible to increase the daily dosage and cut the overall treatment time by approximately 30%, while the total dose administered is equivalent to two conventional treatments.

Study in phase I-II

This research, initially undertaken with 20 patients with cancer of the rectum, is in study phase I-II, the main purpose of which is to find the highest dose that can be applied using modulated radiotherapy in combination with chemotherapy. According to Doctor Aristu, the research showed for the first time that a radiation dose equivalent to that administered using conventional techniques can be applied using IMRT – in less time and with very promising rates of pathological response.

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Seattle Genetics And Agensys, An Affiliate Of Astellas, Announce Initiation Of Phase I Clinical Trial Of ASG-5ME For Pancreatic Cancer

Seattle Genetics, Inc. (Nasdaq:SGEN) and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of metastatic pancreatic cancer. ASG-5ME is an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors.

“There is significant need for new pancreatic cancer therapies, demonstrated by the fact that most patients with advanced disease die within one year from diagnosis,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “We believe ASG-5ME, which is an ADC designed to deliver the potent cytotoxic agent MMAE directly to tumor cells, has the potential to provide a new therapeutic option for this aggressive disease.”

The single-agent, phase I, open-label, dose-escalation study will evaluate the safety and tolerability of ASG-5ME in patients with pancreatic cancer and identify the maximum tolerated dose. Secondary objectives include assessing the pharmacokinetics and antitumor activity of ASG-5ME and identifying a recommended dose and regimen for future clinical trials. The study is designed to enroll up to approximately 50 patients at multiple centers in the United States.

Dr. David Stover, Vice President and Head of Research at Agensys, noted that ASG-5ME is an ADC composed of a fully human monoclonal antibody directed to SLC44A4 (AGS-5), a novel cancer target identified by Agensys to be upregulated in a number of epithelial tumors.

The antibody is attached to a highly potent, synthetic agent, monomethyl auristatin E (MMAE), via an enzyme-cleavable linker using Seattle Genetics’ proprietary technology. The novel linker system is designed to be stable in the bloodstream and release the potent cell-killing agent once inside antigen-expressing cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. Preclinical data demonstrate that SLC44A4 (AGS-5) is expressed on more than 80 percent of samples derived from patients with pancreatic, prostate and gastric cancers. In addition, ASG-5ME induced long-term regressions in preclinical models of established pancreatic, prostate and colon cancers.

About Pancreatic Cancer

Pancreatic cancer is a fast-growing and difficult to detect form of cancer that affects the pancreas. According to the American Cancer Society, the annual incidence of pancreatic cancer is estimated to be greater than 43,000 cases, and more than 36,000 people are expected to die from the disease in 2010. Pancreatic cancer is the fourth leading cause of cancer-related death for both men and women. The 1- and 5-year survival rates for people diagnosed with any stage of pancreatic cancer are 25 percent and 6 percent, respectively.

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ABRAXANE For Metastatic Breast Cancer Approved In Australia

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, today announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market ABRAXANE® (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol® in the approved indication. With this approval, ABRAXANE is now cleared for marketing in 36 countries.

“Along with recent approvals in China and South Korea in the Asia-Pacific region, this approval provides an important treatment option for women in Australia with metastatic breast cancer,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “In the US, ABRAXANE has rapidly grown to become the taxane treatment of choice in its approved indication. We are pleased to make ABRAXANE available in the Australian market.”

Abraxis will market ABRAXANE in Australia through a strategic relationship with Specialised Therapeutics Australia, Pty Ltd. Based in Melbourne, Specialised Therapeutics Australia plans to launch ABRAXANE in the fourth quarter of 2008. A reimbursement application to the national Pharmaceutical Benefits Scheme has been submitted.

Breast cancer is the most common cancer experienced by women in Australia. Each year, over 13,000 Australian women are diagnosed with breast cancer. By 2011, it is estimated that nearly 14,800 Australian women will be diagnosed with breast cancer each year.

Abraxis has made significant progress in 2008 in expanding the market reach of ABRAXANE in the Asia-Pacific region. In March 2008, Abraxis’ partner, Taiho Pharmaceutical Co., Ltd., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare in Japan to market ABRAXANE for the treatment of breast cancer. The Korean FDA (KFDA) granted marketing approval in April 2008 for ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. Green Cross Corporation, the company’s partner in Korea, expects to launch ABRAXANE in that country in the first half of 2009. In June Abraxis received approval in China from the China State Food and Drug Administration to market ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is expected to be launched in China in the first half of 2009. In July Biocon Limited and Abraxis launched ABRAXANE in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

ABRAXANE was approved in the European Union in January 2008 for the treatment of metastatic breast cancer after failure of first-line treatment for metastatic disease and in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease.

In 2005, the U.S. Food and Drug Administration (FDA) approved ABRAXANE for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study on which approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit abraxane

In the U.S., ABRAXANE is co-marketed in collaboration with AstraZeneca Pharmaceuticals LP.

In addition to the review by Ministry of Health, Labour and Welfare in Japan, ABRAXANE is currently under active review in Russia.

About ABRAXANE®

ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience’s proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Because solvents are eliminated, ABRAXANE allows for the delivery of a 49% higher dose compared to solvent-based paclitaxel (Taxol®) without compromising safety and tolerability. In a previous randomized Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumor response rate compared to solvent-based paclitaxel.i

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.

About Specialised Therapeutics, Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify and license innovative anti-cancer therapies which may benefit Australians and New Zealanders suffering from this disease. Abraxane is the first of such anti-cancer therapies. Based in Melbourne, Australia, the company is currently negotiating the rights to several more important therapeutic agents for distribution in Australia and New Zealand.

About Abraxis BioScience

Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company’s portfolio includes the world’s first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company’s proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit abraxisbio

FORWARD-LOOKING STATEMENTS

The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the approval and launch of ABRAXANE in Australia. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.

The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.

Taxol® is a registered trademark of Bristol-Myers Squibb Company.

i Abraxane [package insert]. Los Angeles, Calif: Abraxis BioScience, Inc., August 2007.

View drug information on Taxol. Continue reading