Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Renovis stops sciatica drug studies



31 August, 2005: Clinical studies using Renovis Inc’s new drug to treat sciatica failed to show expected results.

Announcing the phase II clinical trial results on REN-1654 in patient-volunteers with sciatica, Renovis said in a release the results indicate that, although therapy showed a positive trend in pain relief, it did not reach statistical significance in its primary endpoint of change in average daily spontaneous pain ratings at the end of a three-week treatment period compared to placebo. 

An analysis of secondary endpoints in the study showed a statistically significant reduction in maximum daily leg pain at the end of weeks one and two in subjects treated with REN-1654 compared with placebo, but the reduction in maximum daily leg pain was not statistically significant after three weeks of treatment due to a spontaneous reduction of pain in the placebo group.

The company has decided to discontinue development of REN-1654 as an oral medication and is instead exploring alternate routes of administration based on the modest effectiveness observed at the dose tested in this study, and safety findings that would limit testing of higher oral doses.

REN-1654 is a small molecule inhibitor of the release of TNF-alpha and other proinflammatory cytokines that has shown activity in animal models of neuropathic pain.

The finding that REN-1654 may provide a modest degree of relief of leg pain for sciatica patients is consistent with published data from several small open-label studies using infliximab or etanercept injections in human patients, which suggested that a reduction of TNF-alpha levels could be a potential treatment for sciatica leg pain. While the company will not continue to develop REN-1654 as an oral medication, it will continue to analyze the data from this study to consider whether there may be alternative routes for advancing this compound or mechanism of action, the release stated.

The phase II double-blinded, placebo-controlled, multi-center study enrolled 74 patient-volunteers who had developed leg pain due to lumbosacral radiculopathy of no more than 12 weeks duration prior to enrollment. Following a baseline week of no treatment during which they recorded daily spontaneous leg pain, maximum leg pain, and other factors related to activities of daily living, study subjects were randomized into two double-blind groups and received single daily oral doses of placebo or 100 mg REN-1654 for 21 days. Individuals who received treatment with an epidural or intrathecal agent, corticosteroids, antiretrovirals, other anti-TNF alpha agents, or topical analgesics within two weeks before the start of the trial were not eligible for the study. Study subjects were allowed to continue standard care with other analgesics, anticonvulsants, anxiolytics or muscle relaxants if they had been using such medications for at least four weeks prior to enrollment, received stable doses for at least two weeks prior to the study, and met all other eligibility requirements including continuing to have persistent moderate to severe pain.

Renovis is a biopharmaceutical company developing drugs to treat neurological diseases and disorders. The most advanced product candidate, Cerovive (NXY-059), is in phase III clinical trials for acute ischemic stroke with exclusive licensee, AstraZeneca AB. Cerovive (NXY-059), an investigational drug under development by AstraZeneca and licensed from Renovis, has a proposed mechanism of action of free radical trapping. It is being studied as a neuroprotectant in clinical trials based on effects seen in experimental models of acute ischemic stroke. The company has a worldwide collaboration and license agreement with Pfizer to research, develop and commercialize small molecule VR1 antagonists, and a research and development collaboration with Genentech to discover and develop anti-angiogenesis drugs and drugs that promote nerve re-growth following nervous system injury.


Pharma News Headlines

Cancer News

Cardiac News


Pharma industry news

Diseases - Alzheimer's, Parkisonson's and Obesity

Contraception and Abortion News


Anti fungal terbinafine launched in Europe: Actavis

HIV entry blocking drug data encouraging: Progenics

Allegra generic to be launched in US

Long-acting pain drug data positive: Pain Therapeutics

New kidney cancer drug seeks EU nod

Inhaled insulin may get US FDA clearance

A vaccine against fungus is on way

Enzyme stops progression of HIV in survivors, confirms study

Aclasta found faster-acting in Paget's disease treatment

Beta blocker can start therapy in heart failure: Merck

Halobetasol generic launched in US

Anemia drug darbepoetin's late-stage studies begin: Amgen

Cholesterol generic gets marketing nod in US: Par

Aricept for severe Alzheimer’s disease too: Eisai

Bone regeneration trials begin in US:Mesoblast

New dye to detect early Alzheimer's

Breast forming gene discovered

Thyroid drug to be supplied by IVAX in US

Rituxan, cancer drug can treat rheumatoid arthritis

Yasminelle, low-dose oral contraceptive approved in the Netherlands

Fluarix, anti-flu shot by Glaxo approved

Increlex, drug to treat `abnormally short’ kids approved in US

Anti-HIV drugs prices cut: Gilead

US FDA approves Takeda’s drug combo for type 2 diabetes

Novartis’ drug for breast cancer recurrence to be given priority review in US

US puts off decision on contraceptive pill again

Shire’s ADHD drug Adderall back on list in Canada

WHO calls for emergency action to halt TB in Africa

Some of the Vioxx suits may be settled: Merck

Nasdaq delists Able on bankruptcy filing

Hospira ships ceftriaxone generics to US

Renovis stops sciatica drug studies

Merck sets up generic arm Genpharm in US

Morning after pills still not within easy reach in US

New cancer combo therapy results positive:OXiGENE

Aceon approved for heart disease treatment in US

Cell Therapeutics to seek approval for lung cancer therapy in US and Europe

Anti-depressant Seroxat defended by GSK against new findings

Vioxx verdict: Merck’s defeat to trigger thousands of lawsuits from US, UK

Aspirin stops colon cancer, but may trigger bleeding

New blood test method approved in US

Skin disease drug turns into anti-tumor therapy for cancer

Step-by-Step instructions for dealing with Asthma Attacks

Potential Alzheimer's Disease drugs under investigation

New Molecule may help obese lose weight

Paxil (Paroxetine) may heighten suicide risks, finds study

"Breast cancer chances higher due to fried chips"

Safety alert on Gambro Dasco’s Prisma renal system

Merck responsible for Vioxx death: Jury

Heart disease deaths more among New Yorkers

Pfizer to offer drugs risk/benefit summary to consumers 

Merck lied to public on Vioxx: lawyer tells jurors

Novartis acquires rights of kidney dialysis drug from SeBo

J&J's Concerta approved treatment of ADHD in teenagers in Canada

US FDA stalls Roche’ Accutane use in pregnancy

Novo Nordisk, Eli Lilly remove insulin products from Australia

British drug supply chain safety questioned after another fake Lipitor find

Wyeth starts support programme for Effexor patients

P&G’s Actonel with Calcium approved for osteoporosis

Pozen gets patent on pain management product

Genmab studies new drug for rheumatoid arthritis

Painkillers may increase blood pressure: study

Nektar buys out Aerogen for $32 m

Predix records positive data on anxiety drug

Insmed files against Increlex approval

Hepatitis A vaccine for kids approved in US

Psoriasis drug data positive: Cytochroma

Novo Nordisk’s 24-hour acting insulin Levemir gets US FDA okay

US FDA approves Teva's generic for osteoporosis 


Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                        Aviation   Pharma   About Us   Feedback   Links

Latest updates    Contact Us - Feedback    About Us