SuperGen Receives Clearance to Begin Clinical Trials With SGI-1776, a PIM Inhibitor

From International Business Times:

SuperGen, Inc. a pharmaceutical company dedicated to the discovery anddevelopment of novel cancer therapies, today announced that it has receivedclearance to initiate clinical trials with SGI-1776, an inhibitor of Pimkinases. The clearance of its Original Investigational New Drug Application("IND") triggers a $5.2 million milestone payment to the former stockholdersof Montigen Pharmaceuticals, Inc. The milestone payment will consist of $2.8million in cash payments and the issuance of approximately $2.4 million inequity, representing approximately 1.5 million shares of SuperGen commonstock.
SuperGen will initiate a Phase I clinical trial to evaluate the safety,tolerability and pharmacokinetic profile of SGI-1776, a novel, orallyadministered, small molecule anticancer compound. The first in human clinicaltrial program will enroll patients with solid tumors with specific emphasis onhormone refractory prostate cancer and refractory non-Hodgkin's lymphomas.These solid tumor types have been reported to overexpress the Pim kinasefamily of proteins at a high frequency. Overexpression of Pim-1 kinase hasbeen shown to be a marker of poor prognosis in these tumors. A second PhaseI/II study is being planned in patients with refractory leukemias in which Pimkinases are also overexpressed, and correlated with poor prognosis and drugresistance.

Web 2.0 ... Health 2.0 ... Research 2.0?

Web 2.0 showed us how social networking, communities, and collaboration could make the Internet a more engaging and interactive experience – think Facebook, Flickr, and YouTube.

Health 2.0 takes a page from the Web 2.0 playbook to enable the health consumer (formerly known as "patient") to also become engaged in their health and wellness. Here we have on-line support groups and condition-specific forums. We have our health information becoming accessible with tools to make it actionable (via personal health record offerings from Google Health, Microsoft HealthVault, and others). We even have on-line forums for medical professionals, enabling physicians to have peer-to-peer social networking (Sermo).

Health 2.0 brings great potential for improving individual wellness as well as public health, but what are the implications for clinical research? Should we anticipate “Research 2.0”?

In its most primal form, Research 2.0 could mean new ways to find patients that may be interested and eligible for clinical trials. Inspire builds strong on-line communities of patients around specific conditions and diseases, then makes clinical trial matching available to these communities.

At another level, PatientsLikeMe.com has demonstrated the willingness of patients to share personal health information and experiences for the benefit of their patient communities. Registered users (and there are several thousand) share functional status, medication and supplement use, and other interventions. As a result of this information sharing, PatientsLikeMe has found a novel Research 2.0 tool – patient-initiated research.

The patients in this community wanted better data to understand if Lithium is of benefit to patients with ALS. In the spirit of “Research 2.0”, these patients are now sharing their experience – via structured, quantitative data – and creating a dataset including the clinical experience of several thousand ALS patients.

A future with Research 2.0 brings opportunity and risk. Patients may be recruited for trials through communities, but patients may also freely create a discussion forum within a community to discuss experience within a particular trial. Imagine a significant percent of the subjects in your randomized and blinded trial virtually “talking” with one another and exchanging experiences and observations. This is a reality one needs to anticipate.

Physicians have long been concerned about Web 2.0, with patients seeking health information on-line and the risks of user-generated content. But there is more to worry about than whether Google can get a diagnosis correct.

Pharma has its own fear of patients in a world of Web 2.0, with concerns over inappropriate identification of safety signals (FYI, any known adverse experience linked to a specific drug that can be traced to an identifiable patient with an identifiable reporter must be reported to FDA).

The dialogue can not be stopped, and so risks (and potential benefits) must be understood. Some (see BMS and Novartis unrestricted grants for social networking) are already seeing this potential . Our patients are talking and the waiting room chatter is now global – are we ready to listen?

Co-posted from www.pharmasherpa.com

Images: Flickr

Access to Clinical Trials Under Fire

From News4Jax.com

Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.

For the rest of this article, please click here.

What do you think should be the process of getting access for individuals to particpate in clinical trials or for the approval rates for new medications from the FDA?

We'd love to hear your thoughts.

Will Change in Washington Bring Change in Clinical Research?

On January 20, 2009 change will come to Washington. Will a new resident in the White House have implications for drug development? Here are a few areas of possible impact:

Investments in Health Information Technology
Both Obama and McCain featured increasing investments in Health Information Technology as part of their healthcare reform proposals, and the recent Max Baucus reform proposal continues the trend. While the intent from the politicians is to decrease medical costs, reduce errors, and improve quality, there is great potential for clinical research as a by-product. The proliferation of electronic medical records and personal health records can bring transformation in the conduct of clinical research -- new opportunities to find patients, integration of EMRs and electronic data capture (EDC), running virtual trials, identifying biomarkers, the list goes on.

Personalized Medicine
Obama demonstrated awareness of the potential for personalized medicine back in 2006 when he introduced the Genomics and Personalized Medicine Act. And while the act never became law, the passage of GINA earlier this year did bring some protection around the use of genetic information. Outgoing HHS secretary Michael Leavitt has left a note to Obama emphasizing personalized medicine as a potent tool for repairing the healthcare system, which should be a good reminder to the new president that there is still work left undone. Increased investment in personalized medicine will bring more companion diagnostics into clinical development with each new drug, affecting everything from sample size to study logistics.

Continuing Focus on Drug Safety
Most feel the pendulum has swung and the FDA is focusing on safety over accelerating drugs for efficacy. With the media focusing on everything from safety of drug imports (including ingredients used to manufacture drugs) to what seems like every anecdotal report, there is no sign of this trend changing. For clinical development, sponsors will continue to aspire to accelerated approvals -- but will plan for the realities of studies large enough to demonstrate safety (to prove that every needle has been found in the haystack).

Beyond Safety and Efficacy -- Comparative Effectiveness
Once upon a time it was sufficient to run a development program to demonstrate safety and efficacy. Lessons learned from the UK's National Institute for Health and Clinical Excellence (NICE) have taught us the future adds a third endpoint -- comparative effectiveness. In fact, recent healthcare plans in Washington suggest creating an independent "Comparative Effectiveness Institute" for the United States, tasked with head-to-head comparisons of quality and cost for one drug vs. another. Be sure to have a few more voices at the table when writing that next registration study protocol (outcomes research, evidence-based medicine, etc).

Autism and Vaccine Safety Research
Obama and McCain were both enjoying the response of crowds on the campaign trial when raising the potential link between autism and vaccines. Assuming this campaign themes travel from Chicago to Washington in January, there is certainly the suggestion of additional research for vaccines new and old.

Stem Cell Reversal
Most seem to be anticipating an Obama reversal of the Bush restrictions on stem cell research. If this happens and if this research is successful, it would still be several years before one would see any heightened impact of stem cells in clinical research. But clinical trials of stem cells would certainly bring heightened planning -- from dose setting to safety monitoring.

New FDA Leadership
Other far more qualified political sources have taken educated guesses at naming the next FDA commissioner (including Scientific American's proposal of Stephen Colbert). We will need to wait and see in a few weeks, but the new leadership will certainly be expected to bring change within the agency -- which in turn will bring it's impact on clinical research.

Doing More with Less (and less and less...)
We have heard it time and time again. Big pharma are being hit by loss of patent protection to generics coupled with a weak pipelines and the growing risk of reimportation. And now small biotechs are expected to see challenges in raising capital to maintain their development work due to the credit crisis. This conspires to mean a familiar message for clinical development -- the need to do more (more products, more trials) with less. Except the "more" seems to keep growing and the "less" keeps shrinking.


What will come to fruition? Time will tell. But at last check we still have an aging population in this country, and plenty of unmet medical need to go around. (Personally, I am going to make sure I know what HIT, EMR, and PHR all stand for...)

Co-posted from www.pharmasherpa.com
Image: Flickr

India Times: Recession not to hit clinical trials: CROs

The Economic Times

The $200-million Indian clinical research outsourcing market will reach up to $600 million by 2010, according to a joint study done by research firm KPMG and the Confederation of Indian Industry (CII) in September this year. “Credit restrictions will prompt global biotech companies to see greater favour in outsourcing clinical trials to India,” Partner- Healthsciences Practice, Ernst & Young India, Ajit Mahadevan said. While the cost of clinical trials vary on the basis of complexity and disease segment, a simple trial in India can cost 15-20% of the US price, while a more sophisticated trial—involving imaging systems—may be 50-60% of the US price. Studies suggest that R&D expenditure is increasing by 15% per year, making global biopharmaceutical companies look for cheaper options. India scores high due to faster enrollments, speed of completion, large and diverse patient pool as well as increasing private healthcare network.

For the rest of the article, please click here.
We'd love to hear your thoughts on this!

From CNNMONEY

The Independent Data Monitoring Committee (IDMC) constituted to oversee the conduct of the Phase III OVArian TUmor REsponse (OVATURE) Trial, yesterday recommended continuation of the study.
The OVATURE trial is a major multi-center international Phase III clinical trial of orally-administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin.
Read more here.

AHA Meeting 2008

According to MedPage today, the American Heart Association said that lipid studies have caused a surge in discussion about clinical trial bias.

Large multinational clinical trials require a "global set of standards of conduct and behavior" to ensure that outcomes reflect objective, unbiased evidence, a prominent cardiology researcher said here.

Because pragmatic clinical trials provide the foundation for clinical practice, a global imperative exists to develop internationally recognized and accepted "rules of conduct," Robert Califf, M.D., of Duke in Durham, N.C., said during a plenary session at the American Heart Association meeting.

The first step in developing those standards should be to bolster the independence of data monitoring committees, he said.

Read more here.

Science Daily: National Call For Cancer Clinical Trial System To Be More Responsive To Community Needs

The United States has seen poor performance in recruiting individuals for cancer clinical trials--especially individuals of lower socioeconomic status. According to this article in Science Daily, new efforts are going to be made in the marketing, design and overall outreach approach to particpation by this population in the cancer clinical trials. A landmark report just released yesterday by the Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy will aid and map out this effort.

Read more here.

Medtronic reveals results of clinical study done in the United States

Results from 66 patients from across the country participating on a study in transcatheter pulmonary valve for congenital heart disease resulted in:

... a high acute procedural success rate of 98 percent. At six-months follow up, maintenance of excellent valve competence was demonstrated as was a corresponding, clinically-significant, reduction of more than 18 percent in right ventricular volume. Valve competence was assessed by median pulmonary regurgitation fraction, which was down to 0 percent from a baseline of 30 percent.

Read more here.

Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit

Health Minister Mary Harney has officially opened the Oncology Clinical Trials Unit in Cork University Hospital (CUH). The unit provides access to research studies designed to test new treatments in cancer care. A clinical trial is set up at the end of a long and careful clinical research process in order to test a newly developed drug or procedure which shows promise. Patients who participate in clinical trials may be the first to benefit from the latest cancer treatments.

Their care is closely monitored during and after the trial. Clinical trials also offers patients an opportunity to make a contribution to cancer research.

Read more here.

Medical News Today: Researchers Find Relationship Between Brain Fluid And Adult Seizures

According to a new study published early online and in the December issue of Lancet Neurology, researchers better understand the disease mechanisms behind brain seizures that are due to the tapeworm-derived parasitic infection called neurocysticercosis. Their finding that the seizures are frequently associated with fluid or perlesional oedema (PO) around dead calcified cysticercal granulomas (immune cells) may lead to better possible treatment targets.

For more information on this study please visit: Medical News Today

New clinical trial for eye device

Doheny has partnered with Second Sight Medical Inc to develop a device that could help people suffering from night blindness and blindness caused by old age.

Rajat Agrawal, an assistant professor at Doheny commented, “We are creating an artificial retina. We are creating an artificial device where that function (is) to be superseded so that you are able to simulate the impluses to go on to the optical nerve and to the brain.” For more information, read here.

Sanofi-Aventis SA halts clinical trial

Sanofi-Aventis SA halted all clinical trials involving Acomplia, an obesity medicine after authorities in several countries requested them to stop the trials. According to Bloomberg, this comes after European regulators stated last month that the drug was too dangerous for sale. The trials were global, including 500 patients in France. According to FierceBiotech, patients who were taking the medicine experienced a doubled risk of psychiatric disorders.

E-governance for Indian clinical trials

The Economic Times recently announced that the Indian government could be using e-governance for clinical trials in India as soon as 2013. This would allow companies to file online applications for approval of their clinical trials. They would be the first country to approve clinical trials electronically. Read more here.

Study Optimizer gets an upgrade

DecisionView has upgraded its software that increases the efficiency of clinical trials. It's designed to help improve the patient recruitment process during clinical trials. The new version of the software has features that included improved user experience, performance, scalability and reliability. Find out more here.

Do you use this software in your clinical trials? How has it improved your performance?