Image Cranky commentary by Cynthia Robbins-Roth To continue the spirit of Halloween, we start off our monthly roundup of BioWhirled fun with this important news flash from my favorite journal, The Funny Times...FBI agent Stephanie Douglas was pretty clear about what the evidence showed in court: "Mr. Harkonen lied to the public about the results of a clinical trial and offered false hope to people stricken with a deadly disease...This all started with clinical testing for a prenatal test for Down

Restructuring Roundup: Repros Therapeutics Inc...Basilea Pharmaceutica International Ltd.'s case against Johnson & Johnson for messing up development of the antibiotic ceftobiprole got a boost when the FDA slapped J&J with a warning letter for clinical trial conduct...got smacked with another FDA clinical hold on its planned Phase I trial of human embryonic stem cell-based therapy GRNOPC1 in spinal cord injury

According to Chief Scientific Officer Marina Guillet, the company specializes in the use of blood tests on kidney transplant patients with signs of chronic humoral rejection and it aims to develop the KRej-X signature as a diagnostic tool in a prospective clinical trial...TcLand Expression, which was founded in 2002 and is based in Nantes, in western France, completed a series A funding round in December 2007 in which it raised €8.2 million from an international group of institutional and

The company has initiated seven clinical trials of IMP321 over the last four years, and in January reported positive interim results from an ongoing Phase I/II trial in metastatic breast carcinoma...Our positive results in chemo-immunotherapy have encouraged us to engage in discussions with potential partners over Immutep's plans for IMP321," he said.

BioWorld International Correspondent PARIS - Biocortech has been given the go-ahead by the Comité de Protection des Personnes (CPP), the ethical research committee that has to approve all clinical trials in France, to conduct a proof-of-concept clinical trial to validate a biological test for depression...We are very pleased to see Biocortech's test entering clinical development," said the company's CEO, Dinah Weissmann...This is a major step toward starting to assess the full clinical and

TcLand Expression, which raised €8.2 million (US$10.87 million) in a series A funding round in December 2007, also provides immuno-profiling and immunological testing services for biopharmaceutical companies conducting clinical trials in oncology, autoimmune diseases, vaccination and transplantation...Three new companies moved into the campus in 2008, increasing the total number of people employed there to 550.

BioVex said that given the clinical data generated to date, coupled with the mild side effects, OncoVex GM-CSF has the potential to become a leading treatment for many solid tumors...The funds will be used to expand the company's clinical trial programs focusing on bone and cartilage regenerative products for spinal vertebral disc disease...The placement of 15.02 million shares was oversubscribed and was made at a 10 percent discount to the closing price of the company's shares on March 25. #kicker123

Trophos is engaged in a protocol assistance procedure with the EMEA to finalize the design of the clinical efficacy study and to determine the regulatory requirements for obtaining marketing approval for olesoxime as a treatment for SMA...According to the CEO of NicOx, Michele Garufi, taking NCX 6560 into clinical development reflects the company's determination to "expand our drug discovery projects in the cardiometabolic area, where nitric oxide plays a fundamental physiological role...Coreg CR

Under the collaboration agreement between the two companies, Novo Nordisk, of Copenhagen, now has full responsibility for preclinical and clinical development for this program, as well as for filing any possible drug candidates that result from it for regulatory approval...To date, Novo Nordisk has taken three monoclonal antibodies into regulatory preclinical development: IPH 2101, now in clinical trials in cancer, and IPH 2201 and IPH 2301, which are in preclinical development in inflammation...The

He is currently head of division for European Union cooperation/microbiology at the Paul-Ehrlich-Institut, in Langen, Germany, and an expert in quality and safety of biological medicines, clinical trials and risk mitigation strategies for first-in-man clinical trials, and nonclinical development of biotechnology-derived medicines...She is responsible for marketing authorizations of biological medicinal products at the National Agency for Medicines in Finland, and associate professor in biochemistry

Innate, Vivalis Collaborate in Monoclonal Antibodies Innate Pharma SA and Vivalis signed a joint collaboration and commercial license agreement covering the use of the Vivalis EB66 cell line for developing an industrial process to manufacture clinical batches of IPH 4101, a novel cytotoxic monoclonal antibody developed by Innate Pharma for the treatment of rare cutaneous lymphomas such as Sezary syndrome and transformed mycosis fungoides...The French Innovation Promotion Agency, OSEO, has advanced

The most advanced compound to have emerged from the collaboration between the two companies so far is EHT/AGN 0001, which is nearing the end of a Phase I clinical trial in pain indications...The two companies earlier halted clinical development of LFA-1 for the treatment of systemic immuno-inflammatory diseases after hepatotoxic side-effects were observed following oral administration...We are confident that this project has a real potential for success, firstly because the compound has already showed

The interim results showed a clinical response rate of 50 percent compared to 25 percent with paclitaxel alone, as well as a robust immune response in clinically responsive patients...for the advanced development stages of IMP321, as we continue to collect data from this study at the highest dose," he said.

The company also pointed out that the change in expiry date fitted in with its decision to speed up the clinical development of inecalcitol on the strength of the encouraging results obtained from the ongoing Phase IIa trial in the indication of hormone-refractory prostate cancer, which is running ahead of schedule...Clinical trial results to date have demonstrated that it has lower toxicity than calcitriol, the natural active metabolite of vitamin D3, leading Hybrigenics to believe that

In light of these promising clinical results," said Transgene's CEO, Philippe Archinard, "our product development strategy for TG1042 has evolved to a more ambitious one...As a consequence, we are halting sole development of TG1042 and are seeking a pharmaceutical partner to undertake clinical development in a number of onco-dermatology indications...Today, we are convinced that a partnering strategy will fully optimize our adenovirus franchise, thereby creating more value for the company." #kicker123

continued to show improvements in the resolution of their signs and symptoms of treatment-failure gout with continuing pegloticase treatment, extending the positive clinical results seen in Phase III...The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proportion of patients with favorable response over time...Incyte Corp., of Wilmington, Del., reported results from a 28-day Phase IIa trial showing that its orally available janus kinase (JAK

According to staff writer Amanda Pederson, "Based on this early analysis of the two Phase III clinical trials, Allergan says it hopes to file a supplemental biologics license application (sBLA) with the FDA to use Botox in chronic migraine by the middle of next year...25's Financing Roundup that "Tobacco the killer also could become tobacco the healer under a strange-yet-not-so-strange bedfellows type arrangement between Canadian vaccine maker Medicago Inc

There is significant clinical need for a new systemic agent, and FG3622 has the potential to...Jean-Francois Labbé, SpePharm CEO, said the transactions will help SpePharm build up its sales and marketing force, launch and promote its current products and acquire the rights to additional products.

It will use the money for general operations and for a Phase I clinical trial for its lead oncology product candidate, CLR1404, which is planned to start this summer...The company said it will use the money to complete development of its instrument system, reagent kits for disease-specific clinical research, future diagnostic tests and to support research and development efforts