Cognition Pharmaceuticals Reports its Lead Compound Statistically Significantly Improves Memory in Ills

Cognition Pharmaceuticals LLC of New York has reported very compelling results of a Phase II trial that demonstrated statistically significant results in a population of patients with cognitive decline associated with Multiple Sclerosis. The results are interesting on many levels. The trial failed to meet its primary end-points that were supposed to measure a drug effect on executive function but its secondary end-points that measured the drug’s effect on memory were significant. It seems Cognition may have had a case of asking the wrong question, but getting a better answer than they either hope for or expected. Cognition, it is time to change the hypothesis.

I tend to cast a jaundiced eye to trials with mixed results; however, the provenance of this agent is extraordinary. Its developers include Mark Bear, the Picower Professor of Neuroscience at MIT (the blog covered his pioneering work in identifying a path to curing Fragile X), Nobel Laureate, Leon Cooper and Neurosurgeon, Mel Epstein. This team represents the smartest kids in the class. The original theory of the compound’s mechanism of action was it would improve memory consolidation. This trial clearly illustrates that type of activity. The trial also confirms results from the compound's results animal models. The former CEO of the Sention, the company that originally developed the compound, commented in a recent book Can't Remember What I Forgot: The Good News from the Front Lines of Memory Research by Sue Halpern, that it, “…shot for the moon and missed.” In fact, Sention was probably on the mark and the compound was simply abandoned before broadly targeted trials were executed (Ms. Halpern, it is time to update your book before its next printing).

Central Nervous System (CNS) drug development is the Vietnam of the pharmaceutical industry. In the last year we have seen compounds from Myriad Genetics, Lexicon, Targacept (multiple indications), Memory Pharmaceuticals (multiple compounds and multiple indications), Nurochem, and Elan, all failed to meet primary end-points and almost all these compounds showed no signal in ills. Thankfully the C105 trial seems to have been well designed and executed. In a rare circumstance, a drug company maintained a mindset driven by science instead of marketing. This trial clearly demonstrates C105 is an active compound. Furthermore, the compound mechanism of action would argue a wide use across a wide variety of indications including but not limited to chemobrain, mild-Cognitive Impairment, cognitive impairment associated with Parkinson’s disease, cognitive impairment associated with Multiple Sclerosis, traumatic brain injury, and Cognition believes childhood learning disabilities.

Given that C105 is a member of the widely used amphetamine family, the development risk for this compound should be limited. Given its safety profile is good, it could be broadly prescribed. Given the dearth of compounds available to treat cognitive conditions, neurologists and psychiatrists are largely confined to offering off-label scripts that have little if any effect on memory improvement such as modafinil (fatigue), anti-depressants and ADHD drugs (attention); this agent demands to be put into multiple trials across a range of illnesses as the patient community not only will desire it but they deserve it. This drug may address a range of underserved illnesses for patients with unmet needs. Time is of the essence.

I will follow-up on this trial once more information is available.

Happy Holidays from The Healing Project

Everyone at the The Healing Project wishes that everyone in our community have the happiest and healthiest of Holidays.

Donations may be made online by following this link to make a donation.

If you don’t care to make an online donation, please feel free to send a donation by mail to:

The Healing Project Inc. (THP)
5 Laurel RdSouth Salem, NY 10590
http://www.thehealingproject.org/
EIN: 20-4345105
E-mail: - info@thehealingproject.org

THP is 501 (c) 3 not-for-profit organization; all donations are tax-deductible.

If your employer has a giving program, please be kind enough to apply for a matching donation.

Finally, if your company wishes to donate, please have its giving officer contact Melissa Marr, melissa@thehealingproject.org to discuss sponsorship.

Thank you so much for your generous support

May you also have a healthy, happy and prosperous New Year.

Change Is Coming to the Veterans Administration

President-elect Obama has announced his new Secretary of Veterans Affairs and it is Gen. Eric Shinseki. He was severely wounded in Vietnam and spent 11 months in the hospital General Shinseki was the US Army Chief of Staff and was forced to retire by Donald Rumsfeld because he was not acting like part of the team. He dissented vigorously regarding the prosecution of the invasion of Iraq. His resolve cost him his job, and he has since been proven right.

His resolve will be tested again as the Bush Administration filled the VA with hacks, incompetents and apologists. James Nicholson followed the Bush party line right off a cliff. Then, General James Peake became Secretary. General Peake when in uniform, as the US Army Surgeon General, failed to acknowledge, prepare and deal with either Traumatic Brain Injury and mental health issues. As a civilian, he continued the policy as it might expose his incompetence. Hopefully, he will quickly retire from the practice of medicine, his tenure has been a disgrace.

General Shinseki should first resolve to clean-up the VAs administrative mess that fails to screen, admit and treat our wounded warriors. The VA would make Soviet apparatchiks blush with its indifference and ineffeciency. Second, he should immediately demote and fire the entire senior management of VA in mental health and traumatic brain injury. The signature injuries of OIF/OEF can be acknowledged and treated. The very capable staffs of many VA sites can be supplemented with civilian resources to get these service members squared away. The policy of denying benefits based on phony science and mindless research by both the DoD and VA can quickly come to an end. Finally, he must seek to chart an independent path; the DoD has an agenda quite seperate from treating and honoring our warriors.

Hopefully this action will signal to Military Health Systems that it is time to clean its house.

MILITARY PERSONNEL WITH TRAUMATIC BRAIN INJURY AT RISK FOR SERIOUS LONG-TERM

The Institute of Medicine reported this week Military personnel who suffer severe or moderate traumatic brain injury (TBI) face an increased risk for developing several long-term health problems. This evidenced based study reported that conditions include Alzheimer's-like dementia, aggression, memory loss, depression, and symptoms similar to those of Parkinson's disease. Even mild TBI is associated with some of these adverse consequences, noted the committee that wrote the report.

In addition, the report notes that brain injuries sustained as a result of exposure to the force of an explosion without a direct strike to the head -- one of the most common perils for soldiers in Iraq and Afghanistan -- may be underdiagnosed due to the lack of research on blast injury. It calls for the U.S. Department of Defense and the U.S. Department of Veterans Affairs to step up clinical and animal studies of blast-induced neurotrauma (BINT).

The Healing Project would go further and immediately screen and database the 300,000 to 400,000 service members exposed to blasts.

"Explosive devices and other weaponry have become more powerful and devastating throughout the wars in Iraq and Afghanistan, and we are seeing much higher rates of nonpenetrating traumatic brain injury and blast-induced injury among military personnel who have served in these countries than in earlier wars," said George W. Rutherford, professor of epidemiology and preventive medicine and vice chair, department of epidemiology and biostatistics, School of Medicine, University of California, San Francisco, and chair of the committee that wrote the report. "It is important to identify and understand any long-term health effects of these injuries so that wounded service members do not lose valuable time for therapy and rehabilitation."

Studies conducted in Iraq by the Air Force Medical Service with the Headminder system would argue that up to 5% of exposures, that is 15,000 to 20,000 m-TBI injuries, would require additional follow-up. The DoD is only reporting 5,500 injuries total traumatic brain injuries. Furthermore, while animal studies are useful, replicating injuries in animals models are unlikely to provide necessary data to provide human clinical guidance. It is time to implement a web-centric longitudinal screening technology to track the evolution of these injuries in an epidemiologically sound fashion.

While we agree with the Institute in broad strokes, scientists and clinicians have been aware of the injuries and the likely outcome of these injuries since 2004. Neither the DoD or the VA has demonstrated any real interest in identifying or treating M-TBI dealing with its attendant co-morbidities. Both organizations have used research to delay the identification of and/or deny the very existence of the injuries. The report makes it clear blast concussion is not like a sports injury nor is it PTSD (two of the DoDs and VAs favorite excuses why they do nothing). Now that we have a change of government, it is time for Secretary of Defense Gates to clean out DoD HA and US Army Medcom. The delayers, the deniers and the dinosaurs need to be quickly cashiered and replaced by people who will get the job done now.

December 1st through the 7th is National Aplastic Anemia and MDS Awareness Week

Aplastic anemia (a-PLAS-tik uh-NEE-me-uh) is a rare and serious blood disorder in which bone marrow stops making enough new blood cells. Bone marrow––the spongy material inside bones—makes new blood cells called stem cells. Stem cells normally develop into three main types of blood cells: red blood cells, white blood cells, and platelets. Each type of blood cell has its own functions in the body.

Aplastic anemia is a rare condition. In the United States, about 500–1,000 people develop this type of anemia each year. It is two to three times more common in Asian countries.

The two main types of aplastic anemia are acquired and hereditary. Acquired means a person develops the condition during his or her lifetime. Hereditary means a person is born with the condition. Acquired aplastic anemia is the most common type, and it is sometimes a temporary condition. It can be triggered by exposure to:

• Toxic chemicals
• Chemotherapy drugs
• Radiation
• Virus infections

However, the cause of acquired aplastic anemia is often not known.

Hereditary aplastic anemia is rare. It occurs with some inherited conditions, such as Fanconi anemia.

Aplastic Anemia & MDS International Foundation, Inc.
P.O. Box 310
Churchton, MD 20733-0310
(800) 747-2820
(410) 867-0242
(410) 867-0240 Fax
mail%20to:help@aamds.org
www.aamds.org
Materials available
Contact: John Huber

December 1st is World AIDS Day

Joint United Nations Programme on HIV/AIDS

Quick Facts on AIDS in the United States

UNAIDS Secretariat:
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Telephone: +41.22.791.3666
Fax: +41.22.791.4187
mail%20to:unaids@unaids.org
http://www.unaids.org/en/default.asp
Materials available
Contact: None designated

Happy Thanksgiving From The Healing Project

The Healing Project wishes that everyone in our US community has wonderful holiday.

Given this is a celebration on America's bounty, please take a moment to reflect on those that are less fortunate and make a donation to extend our reach to those that have unmet medical needs.

Again have a happy, healthy and enjoyable holiday.

November 20th is Great American Smokeout

It is time to pack it in. The Healing Project knows it isn't easy to go cold turkey but newer drugs like Chantix have demonstrated amazing results in smokers with manageable side-effects. Check for Great American Smokeout programs in your local communites and give it a shot.

Great American Smokeout
American Cancer Society
250 Williams Street NW
Atlanta, GA 30303
(800) ACS-2345 (227-2345)
http://www.cancer.org/

Materials available
Contact: National Office

November is Pulmonary Hypertension Awareness Month

What is PH?
Pulmonary hypertension is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening.

Pulmonary Hypertension Awareness Month
Pulmonary Hypertension Association
801 Roeder Road, Suite 400
Silver Spring, MD 20910
(800) 748-7274 Helpline
(301) 565-3004 x109
(301) 565-3994 Fax
pha@phassociation.org

http://www.phassociation.org/

Materials available
Contact: Katie Kroner

November is National Hospice Palliative Care Month

The Healing Project strongly advocates the pateints and caregivers consider hospice care as the end-of-life approaches. These facilities offer a kind and compassionate place to come to terms with one's mortality.

1.3 million people with life-limiting illness received care from the nation’s 4,500 hospice providers last year. This represents continued growth in both patients served and number of providers. Approximately 35 percent of all deaths in the US were under the care of a hospice program.

Additionally, the top five diagnoses among hospice patients reported by NHPCO show the continued trend of less cancer patients among those served. The top five diagnoses seen in hospice for 2006 are as follows:

Cancer 44.1 percent
Heart Disease 12.2 percent
Debility 11.8 percent
Dementia 10.0 percent
Lung Disease 7.7 percent

Throughout the month of November, hospice and palliative care organizations across the nation are hosting activities to educate the public and other healthcare professionals about the benefits of hospice and palliative care.

Hospice is not a place but a philosophy of care created to help people live with dignity, comfort, and compassion at the end of life. Palliative care works to bring this philosophy of care to people earlier in the course of a serious illness.

Hospice and palliative care programs provide pain management, symptom control, psychosocial support, and spiritual care to patients and their families. They also serve as valuable community resources about care options.

Additional information about hospice, palliative care, advance care planning, and talking with loved ones about these important issues is available from NHPCO’s Caring Connections. For information, to find a local hospice, or to get a free state-specific advance directive form, visit
http://www.caringinfo.org/ or call the HelpLine at 800/658-8898.

National Hospice Palliative Care Month
National Hospice and Palliative Care Organization
1700 Diagonal Road, Suite 625
Alexandria, VA 22314
(703) 837-1500 or (703) 837-3139
(703) 837-1233 Fax
jradulovic@nhpco.org
http://www.nhpco.org/
Contact: Jon Radulovic