Pharmos Corp. (Nasdaq: PARS) today announced preliminary results from its Phase 2a study evaluating intravenous (i.v.) cannabinor, a CB2-selective synthetic cannabinoid compound, in a capsaicin-induced pain model. The drug candidate did not meet the primary endpoint defined by analgesic effects compared to placebo, but confirmed safety and tolerability observed in previous studies. All subjects completed the treatment with no serious adverse events or significant cardiovascular effects.
The randomized, double-blinded, two-way crossover study enrolled 24 healthy male volunteers to compare 48mg of cannabinor delivered intravenously versus placebo on capsaicin-evoked allodynia (pain resulting from a non- noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).
"While we are disappointed that cannabinor did not show efficacy in this pain model, we have a newly developed oral formulation of cannabinor targeting chronic neuropathic pain with repeated administration," said Dr. Haim Aviv, Chairman & CEO. "We plan to move forward with the program for orally administered cannabinor, and our next step is to conduct a Phase I safety trial in healthy volunteers. Based on preclinical results of oral cannabinor, its prospects as a potential treatment for neuropathic pain are promising." Pharmos recently completed preclinical toxicology and safety pharmacology studies of oral cannabinor, the data from which support initiation of Phase 1 testing.
The Company expects to complete its separate, ongoing Phase 2a clinical trial of cannabinor as a treatment for nociceptive pain in the first quarter of 2007. The single-center, randomized, double-blinded, single-administration study compares different i.v. doses of cannabinor with placebo. The completed study will involve 100 healthy male subjects experiencing pain following third molar dental extraction.
About Cannabinor and CB2-Selective Cannabinoids
Cannabinor has demonstrated efficacy in a number of preclinical animal models of pain, inflammation and autoimmune disease. Analgesic activity has been documented in nociceptive, neuropathic, visceral and inflammatory pain in rodents and in post-operative pain in a porcine surgery model. The magnitude of analgesia was generally equivalent or greater than that of accepted comparator agents, including morphine, non-steroidal anti-inflammatory drugs and Gabapentin. In a number of models where duration of analgesia was measured, cannabinor remained effective at reducing pain significantly longer than morphine. Preliminary evidence from preclinical studies also suggests that tolerance to the therapeutic effect of cannabinor might not occur. A drug that remains effective without increasing dosage would be a valuable advance in treating severe pain.
Pharmos' cannabinoid research focus has been geared toward the development of selective and specific CB2 receptor agonists. Because they range from having little (CB2-selective) to barely detectable (CB2-specific) affinity for the central nervous system-located CB1 receptor, CB2-selective and -specific agonists lack the unwanted psychotropic side effects of many natural cannabinoids. CB2 agonists bind to CB2 receptors, which are located on immune and inflammatory cells. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders. Pharmos is developing its CB2 agonists as treatments for chronic pain and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. Cannabinor is the first lead candidate to emerge from this body of Pharmos' proprietary technology.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (gastrointestinal/irritable bowel syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, with positive effect on the primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor and other CB2 agonist compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders. Pharmos is also working to commercialize its unique proprietary NanoEmulsion drug delivery system, which is in clinical stage development for topical application of analgesic and anti-inflammatory agents.
Pharmos Corp.
http://www.pharmoscorp.com
May 7, 2007
Long-Term Narcotics Use For Back Pain May Be Ineffective And Lead To Abuse
Narcotic drugs (opioids) are commonly prescribed for short-term relief of chronic back pain, but their effectiveness long-term has been questioned in a review article by researchers at Yale School of Medicine, who also found that behaviors consistent with opioid abuse was reported in 24 percent of cases.
"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."
Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.
The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.
"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.
###
In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.
Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)
Yale News Releases are available via the World Wide Web at http://www.yale.edu/opa
For further information please go to:
Yale University
"Patients with chronic back pain commonly request pain medication, and opioid medications are used despite the concerns clinicians have with patients developing an addiction to these medications," said first author Bridget Martell, M.D., assistant clinical professor of general internal medicine at Yale School of Medicine. "Our findings suggest that clinicians should consider other treatments with similar benefits but fewer long-term adverse effects."
Published in the January 16 Annals of Internal Medicine, Martell and co-authors conducted a systematic literature review and meta-analysis that addressed the prevalence and effectiveness of opioid prescriptions for patients with chronic back pain, and the incidence of substance abuse disorders among patients receiving opioid medications for chronic back pain.
The study populations consisted of non-obstetric patients over age 18 with non-malignant chronic back pain lasting for at least three months. The research focused on efficacy of oral, transdermal, or topical opioids, where there was no pre-existing diagnosis of opioid dependence. According to the report, opioids may be effective for the short-term (less than four months) treatment of chronic low back pain, but long-term effectiveness was not conclusive.
"Our results also demonstrate that the quality of the literature on these topics is generally weak and more studies need to be done before firm conclusions can be made," said Martell.
###
In addition to Martell and corresponding author David Fiellin, M.D., associate professor of general internal medicine at Yale, other authors on the study included Patrick G. O'Connor, M.D., Robert D. Kerns, William C. Becker, M.D., Knashawn H. Morales and Thomas R. Kosten, M.D.
Citation: Annals of Internal Medicine, Vol. 146, No. 2 (January 16, 2007)
Yale News Releases are available via the World Wide Web at http://www.yale.edu/opa
For further information please go to:
Yale University
Childhood Obesity Linked To Foot Pain
January 17, 2007) Doctors with the American College of Foot and Ankle Surgeons (ACFAS) say they're noticing more and more overweight and obese children with foot and ankle pain in their examining rooms, mirroring a national epidemic of childhood obesity.
An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.
"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.
The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.
Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to FootPhysicians.com, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.
Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.
"The numbers are definitely increasing. I treat four to five overweight children a week," he says.
Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.
Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.
"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.
For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site, http://FootPhysicians.com.
The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website, http://www.footphysicians.com.
American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States
http://www.acfas.org
An estimated 16 percent of U.S. children ages six to 19 are overweight. Poor diet, lack of exercise and genetics can play a role. A "vicious cycle" of foot pain and obesity traps some children.
"You want overweight children to exercise and lose weight, but because of their weight, their feet hurt and they can't exercise," says Thanh Dinh, DPM, FACFAS, a foot and ankle surgeon in Boston.
The foot is a complex structure consisting of 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. Last November, researchers in Britain reported "alarming new evidence that childhood obesity changes foot structure and results in instability when walking." Being overweight flattens the foot, straining the plantar fascia, a band of tissue which runs from the heel to the base of the toes, causing heel pain.
Because the heel bone is not fully developed until age 14 or older, overweight children are more prone to Sever's disease. Although not an actual disease, according to FootPhysicians.com, it involves an inflammation of the heel's growth plate due to muscle strain and repetitive stress. Walking makes the pain worse. Being overweight may also cause stress fractures, or hairline fractures (breaks) in a child's heel bone.
Arch pain afflicts many of the children treated by Darryl Haycock, DPM, FACFAS. The northwest Ohio foot and ankle surgeon says the average age of these boys and girls ranges from eight to 12, but he's treated some as young as four.
"The numbers are definitely increasing. I treat four to five overweight children a week," he says.
Haycock notes some overweight children suffer foot pain from congenital or inherited foot conditions, such as bunions, hammertoes, pediatric flatfoot and tarsal coalition, an abnormal connection between two or more bones in the back of the foot. Children with these deformities may be less active because of pain. Sometimes a child will complain of calf or arch pain. This results from a flatfoot that is flexible. The collapsing of the arch can require more energy, making it more difficult for a child to walk and run.
Foot and ankle surgeons treat many overweight children with custom orthotic devices (shoe inserts), physical therapy and other conservative measures to reduce or eliminate pain. But treating painful feet and ankles is only part of the childhood weight loss equation, says Samuel Nava, DPM, FACFAS. The suburban Dallas surgeon has treated weight-related foot problems in toddlers to teenagers.
"As foot and ankle surgeons, we can reduce the aches and pains so these children can run around and play like all the other kids, but parents need to watch their childrens' lifestyles and diets," he says.
For more information on pediatric foot and ankle conditions, or to find a foot and ankle surgeon, visit the ACFAS patient information Web site, http://FootPhysicians.com.
The American College of Foot and Ankle Surgeons (ACFAS) is a professional society of more than 6,000 foot and ankle surgeons. Founded in 1942, the College's mission is to promote research and provide continuing education for the foot and ankle surgical specialty, and to educate the general public on foot health and conditions of the foot and ankle through its consumer website, http://www.footphysicians.com.
American College of Foot and Ankle Surgeons
8725 W. Higgins Rd., #555
Chicago, IL 60631
United States
http://www.acfas.org
Leading Radiofrequency Manufacturer Introduces A New Product For Treating Heel Pain
NeuroTherm, Inc., a global leader in radiofrequency generators for chronic pain management, announces the introduction of an RF product specifically for the podiatric market: The PodiaTherm RF Generator, designed to treat chronic heel pain, which often is associated with plantar fasciitis.
Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.
"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."
The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.
"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.
"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.
According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.
Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.
NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.
NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at http://www.neurotherm.com.
Additional information about the PodiaTherm RF Generator can be found on the Internet at http://www.podiatherm.com.
NeuroTherm, Inc.
http://www.neurotherm.com
Plantar fasciitis, or inflammation of the plantar fascia, is considered the most common cause of heel pain. The plantar fascia is a ligament connecting the heel bone to the toes and supporting the arch of the foot. If strained, it can develop small tears and be weakened, swollen or irritated, thus resulting in pain while walking or standing.
"As many as two million Americans are affected by plantar fasciitis each year," says William Rittman, NeuroTherm's Chief Technology Officer. "Of those, approximately 10 percent require advanced treatment because conventional therapies, such as over-the-counter medications, splints and rest, haven't alleviated the pain. That's where PodiaTherm can help."
The PodiaTherm employs radiofrequency therapy to block the pain by affecting the nerve causing the pain, Rittman says. Basically, the physician isolates the sensory nerve, which is a branch of the lateral plantar nerve, and inserts an RF electrode. The PodiaTherm then transmits a signal through the electrode, creating a lesion on the nerve in a process called thermoneurolysis.
"Once conventional therapies have been exhausted, patients have had fewer treatment options other than surgery. This will be a minimally invasive, office-based procedure," says Laurence Hicks, NeuroTherm CEO and President. Previously, advanced, non-surgical therapies either required bruising the tendons with shockwaves or making an inch-long incision to treat the tendon internally. The PodiaTherm requires only a local anesthetic and a needle's width incision. The RF therapy can be performed in a physician's office, at a hospital or in a surgery center.
"RF therapy with the PodiaTherm will become the treatment of choice for many podiatrists and patients, particularly because it's a simple, effective and safe procedure," Hicks states.
According to Rittman, radiofrequency therapy has been used successfully for many years to treat chronic pain. The RF procedure is commonly reimbursed through insurance. It also will cost less than other non-conventional therapies.
Moreover, the PodiaTherm is a small machine, so it can be transported easily from one facility to the next as the physician requires.
NeuroTherm, Inc. is a leading manufacturer of radiofrequency generators and related consumables used in the treatment of chronic pain. The company recently introduced the NT1000, the world's first RF generator capable of producing three lesions simultaneously. NeuroTherm also pioneered the development and use of disposable electrodes in the U.K. market.
NeuroTherm is based in Middleton, MA., with another facility outside London, England. The company was formed in September 2005, as a concurrent acquisition of RDG Medical in the U.K., and RF Medical and Precision Medical Engineering in the U.S. by Cortec Group Fund III, L.P., an affiliate of Cortec Group, Inc. Additional information about NeuroTherm can be found on the Internet at http://www.neurotherm.com.
Additional information about the PodiaTherm RF Generator can be found on the Internet at http://www.podiatherm.com.
NeuroTherm, Inc.
http://www.neurotherm.com
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