Results tagged “clinical trials” from Drugs & Medicaments

BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.

With budget cuts looming at the National Cancer Institute, a publicly funded cancer cooperative has begun to shut down clinical trials and stop some research programs on a variety of cancers. Among the hardest hit areas, according to a report in The Wall Street Journal, will be rare cancers like sarcoma and head and neck cancers.

The cooperative said that it was eliminating 3,000 spots in clinical trials this year and some groups were shuttering entire trials. The groups were asked to explore ways to cut operations due to flat funding from the federal government, which has been tightening the rein on research funds as it tries to ratchet down the federal deficit. The NCI's proposed budget includes a $9 million reduction in funds--which amounts to a .2 percent slice out of its current budget--so more research cuts are anticipated.

- read the article from The Wall Street Journal (sub. req.)

source FierceBiotech 

(Ivanhoe Newswire) -- A drug researchers hoped would boost birth rates among women with one of the most common causes of infertility fell short in a new study.

Metformin (Glucophage), which is used to treat diabetes, shown promise in earlier research involving women with polycystic ovary syndrome (PCOS) because it increased the frequency of ovulation. In the new study, however, increased ovulation did not lead to increased births.

In fact, women taking metformin had the lowest birth rates in the study, which compared the drug to the standard drug used to treat infertility in PCOS, clomiphene (Clomid). About a quarter of the women taking clomiphene ended up giving birth, compared to about 7 percent of those taking metformin. Combining the two treatments did not lead to better results, with about a quarter of women again having children.

Tests of drugs on animals are not reliable in all cases, a study warns.

The British Medical Journal research looked at studies in six areas and found animal studies agreed with human trials in just three.

The high-profile London drug trial which left six men ill was carried out after animal studies showed the drug TGN1412 was effective.

This study, led by Professor Ian Roberts, suggests animal studies should be used, but not for all drug research.

Telik Inc. said on Tuesday that its experimental cancer drug failed to improve survival in patients with advanced lung cancer or in patients with ovarian cancer, sending its stock plunging nearly 70 percent.

The biotechnology company said a late-stage, or Phase III, trial of its most advanced drug, Telcyta, did not significantly improve survival in patients with advanced lung cancer who had failed other treatments, which was the main goal of the trial.

The Palo Alto, California-based company said a Phase III trial of patients with resistant ovarian cancer also failed the trial's main goal of demonstrating significant improvement in survival.

Altus Pharmaceuticals Inc. will make at least $15 million in a new development deal signed with biotechnology giant Genentech Inc. to create treatments for human growth hormone deficiency.

Cambridge, Mass.-based Altus (Nasdaq: ALTU) announced on Wednesday that it would work with Calfornia-based Genentech (NYSE: DNA) to develop, manufacture and commercialize ALTU-238, Altus' once-per week formulation of human growth hormone.

The alliance focuses on a collaboration and licensing deal in North America, and Genentech will pay Altus $15 million up front; The company gets another $15 million through a Genentech investment in Altus stock. Altus can make up to $140 million more if the collaboration produces milestones in development and commercialization.

GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq: GNVC) announced today that an independent data safety monitoring board (DSMB) has completed a planned interim analysis of safety data from the ongoing Phase II/III clinical trial with TNFerade™ in locally advanced pancreatic cancer. In addition to its recommendation that the trial continue, the DSMB supported the use of endoscopic ultrasonography (EUS) as an alternative to percutaneous tumor administration. GenVec has provided its interim safety data to the U.S. Food and Drug Administration (FDA) and is waiting for final clearance to move forward with EUS administration.

The Phase II/III clinical trial, known as PACT, is a multi-center, randomized and controlled study of 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care, versus standard of care alone (SOC) in patients with locally advanced pancreatic cancer. This interim evaluation was based on data from 40 patients, 25 of whom received standard of care plus TNFerade.

A LIVER cancer trial of a Brisbane biotechnology company's drug turned out positive results which analysts yesterday described as a "cracker".

The results from the second-round trial were also encouraging enough for Toowong-based Progen Industries to proceed with more advanced research and plans to raise funds.

The sharemarket initially seemed ambivalent, which was linked to investors potentially needing time to absorb the results or an attempt to knock down the share price. But by the afternoon a rush pushed shares up 84¢ to $4.99 – still off all-time highs of $13.18 in February 1997.

Memory Pharmaceuticals Announces Release of Clinical Hold on MEM 3454

MONTVALE, N.J., Dec. 11 -- Memory Pharmaceuticals Corp. today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the Company that the clinical hold on the development of this drug candidate has been released. The Company now plans to commence its previously-announced Phase 2a clinical trial for MEM 3454 in Alzheimer's disease during the first quarter of 2007.

"Memory has worked diligently with the FDA since this trial was placed on clinical hold in October, and we are pleased that we will now be able to move forward with the proof-of-concept trial for this important drug candidate," stated Jim Sulat, President and Chief Executive Officer of Memory Pharmaceuticals.

CHICAGO (Reuters) -- An experimental blood clot dissolver by Nuvelo Inc. and its German partner Bayer failed to meet its main goal in two late-stage studies, sending the U.S. biotechnology company's shares down more than 79 percent Monday.

Nuvelo (down $15.50 to $4.05) shares closed at $4.05, down $15.50.

The companies said they had temporarily suspended enrollment in all trials of the alfimeprase compound pending further analysis and discussions with outside experts and regulatory agencies.

The news rattled investors, who had high hopes for the drug.

"We are very surprised by these results, given the strength of the prior (midstage) results," said CIBC analyst Bret Holley in a note to clients.

BASEL (AFX) - Roche Holding AG said an interim analysis of a Phase III study of Avastin in advanced renal cell cancer has shown that the drug significantly prolongs progression-free survival.

Due to the benefits observed, the independent Drug Safety Monitoring Board has recommended that the study be unblinded and all patients will be offered treatment with Avastin.

In addition, this early analysis indicated a trend towards an improvement in overall survival.

Renal cell cancer is the most common form of kidney cancer accounting for nine out of ten cases and treatment options are limited.

Safety was in line with what has been observed for Avastin in previous studies.

source - AFX 

BASEL (AFX) - Roche Holding AG said that its latest Phase III study of cancer treatment Xeloda with 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival.

Study results showed that the chemotherapy combination XELOX -- consisting of oral Xeloda plus oxaliplatin -- was as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

The data will be used in worldwide submissions of the drug.

After six members of a Phase I trial of TeGenero’s TGN1412 nearly died, an expert scientific group, headed by Professor Gordon Duff, was convened to investigate the incident and recommend new procedures to increase the safety of future ‘first-in-man’ trials.

The drugs, which passed standard pre-clinical trials, were supposed to subtly “retune” the immune system. Instead they sent the immune system into overload and the members of the trial suffered multiple-organ failure. The effects were so severe that fingers and toes had to be amputated.

The report called for increased communication between the drug developer and the regulatory body before application for Phase I trials. Pre-clinical trial safety information should be submitted to a database to speed-up the process. This should allow the regulators to identify potential concerns and discuss these with appropriate independent specialist experts.

A new anti-obesity drug that works in the same way as Sanofi-Aventis's Acomplia has advanced in clinical trials, triggering a $25 million payment to Belgian drugs, chemicals and plastics maker Solvay.

Solvay said on Friday it had started further Phase II clinical tests of its SLV319 drug following encouraging early results, prompting the payment from its partner Bristol-Myers Squibb Co.

"Clinical and preclinical studies involving this class of drug have shown that blocking the cannabinoid type 1 (CB1) receptor results in reduced food intake," Solvay said in a statement.

The $25 million will be booked into the fourth quarter 2006 figures but Solvay Pharmaceuticals is increasing its R&D and marketing spending by a similar amount.

LEVERKUSEN, Germany (AFX) - Bayer (nyse: BAY ) AG and Onyx Pharmaceuticals Inc said Phase III skin cancer tests of their Nexavar (sorafenib) tablets failed to meet their primary endpoint of improving progression-free survival (PFS).

'We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for whom treatment options are so limited,' Onyx chief executive Hollings Renton said in a statement.

'However, this trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumours and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity.'

source - AFX 

Pfizer Inc. said Saturday it has cut off all clinical trials and development for a cholesterol drug that was supposed to be the star of its pipeline because of an unexpected number of deaths and cardiovascular problems in patients who used it.

The world's largest drugmaker said it was told Saturday that an independent board monitoring a study for torcetrapib, a drug that raises levels of HDL, or what's commonly known as good cholesterol, recommended that the work end because of "an imbalance of mortality and cardiovascular events."

The news is devastating to Pfizer, which had been counting on the drug to revitalize stagnant sales that have been hurt by numerous patent expirations on key products. It has said it was spending around $800 million to develop Torcetrapib.

SAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.

Canadian biotech drug maker AEterna Zentaris Inc. said Monday that women enrolled in an early stage clinical trial were able to tolerate its experimental cancer treatment.

In the study, 17 women with gynecological and breast cancers were given increasing doses of AN-152, and tolerated the maximum dose of the treatment well, according to the company.

AEterna Zentaris also said that results hinted at effectiveness of the treatment.

China Biopharmaceuticals Holdings, Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

TRIALS of a potential new cancer treatment made from a noxious weed have been halted after concerns were raised by the drug regulator.

Australian manufacturer Solbec Pharmaceuticals has suspended testing of its developmental drug Coramsine, designed to work alongside chemotherapy to treat advanced cancers.

The company was about to enlist up to 120 skin cancer and kidney cancer patients for trials at 16 hospitals nationwide.

However, concerns raised by the Therapeutic Goods Administration (TGA) have put the studies on hold.