Phase I

BMS inks $710M development deal with PDL

John Carroll — Wed, 20 Aug 2008 10:20:13 -0400

Bristol-Myers Squibb is paying $30 million upfront in a licensing deal for PDL BioPharma's experimental blood cancer vaccine elotuzumab. And will it pay up to $680 million more if the Phase I cancer therapy hits all of its development and sales milestones. The anti-CS1 antibody binds to a protein that plays a key role in multiple myeloma, flagging it for destruction by the human immune system. BMS agreed to cover 80 percent of the development costs with PDL putting up 20 percent. The two plan to share profits in the U.S. And the deal includes an option to collaborate on PDL241 after it completes preliminary testing.

"Consistent with our company's strategy to integrate external innovation and to expand our capabilities, this collaboration will further strengthen our pipeline of agents targeting hematologic malignancies, which includes SPRYCEL and tanespimycin, an Hsp90 inhibitor from our recent acquisition of Kosan Biosciences," said Francis Cuss, M.D., senior vice president, discovery and exploratory clinical research, Bristol-Myers Squibb.

--read the AP report
--read the Bristol-Myers Squibb release

BioVascular raises $10.87M

Fri, 08 Feb 2008 06:59:57 -0500

With the help of lead investor BB Biotech Ventures, BioVascular rounded up $10.87 million in series C financing. The San Diego, CA-based company plans on using the money to complete clinical trials of its two compounds, Saratin and BVI-007. Saratin--which is currently in Phase I/II--is being developed to reduce the failure of vascular grafts due to intimal hyperplasia. BVI-007 reduces platelet production without affecting platelet function, and is being studied in a Phase Ib dose selection clinical trial.

- see BioVascular's release for more

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ALSO NOTED: Tacere gains Pfizer deal; InterMune reports positive hep C results; ArQule CEO resigns; and much more...

Tue, 08 Jan 2008 06:59:50 -0500

> Tacere Therapeutics has inked a development deal with Pfizer for its preclinical hepatitis C drug. The deal is worth up to $145 million in potential milestones and Pfizer is paying an undisclosed upfront fee. Release

> Shares of InterMune jumped after the company announced that the Phase Ib trial of a new hepatitis C therapy delivered positive results. Report

> U.S. regulators have canceled an advisory board meeting regarding Jerini's icatibant, removing a possible obstacle to its approval. Release

> The CEOs of ArQule and Isolagen have announced plans to leave their respective companies. Report | Report

> Watson Pharmaceuticals says that its experimental gel therapy for overactive bladder met its goal in a late-stage trial. Release

> NextGen Sciences and Paragon Bioservices announced a marketing deal for their development services. Release

> NicOx signed an extension of its March 2006 collaboration agreement with Pfizer covering the exclusive right to apply its proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology. Release

> China's biotech sector is small compared to its pharma activities, but it's growing fast. Report

> The very drugs prescribed to strengthen bones can spark stabbing limb and joint pain, according to a reminder from the FDA. Report

> A peptide produced by the brain to ward off the effects of fatigue could be the key to combating sleep disorders such as narcolepsy, according to new research. Report

> Looking to boost New York's reputation as a thriving center of scientific research, Gov. Eliot Spitzer has handed out the first series of grants from a new $600 million fund designed to support stem cell research programs. Report

> Prescription drug spending surged in 2006 as the government's benefits for the elderly kicked in, according to a federal study. Report

And Finally... House Democrats are investigating whether consumers are being misled by commercials in which Dr. Robert Jarvik (photo) endorses of Pfizer's Lipitor. Though Jarvik invented the artificial heart, he has never practiced medicine. Report

Novacea slows down development program for AQ4N

Thu, 03 Jan 2008 06:59:55 -0500

Novacea, which is burning through $17 million to $19 million this year, says it will scale back on the development of AQ4N, shelving a clinical trial in acute lymphoblastic leukemia and delaying a clinical trial in B-cell lymphoma. The news was included in a strategic review of its plans for 2008. An ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme will continue.

"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," says Novacea CEO John Walker.

- see Novacea's release
- read the report from Trading Markets

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Medarex shares dive after a cancer trial failure

Tue, 11 Dec 2007 06:59:56 -0500

Shares of Medarex took a dive in after-hours trading after the biotech announced that the cancer drug ipilimumab--being developed in collaboration with Bristol-Myers Squibb--had failed one of the studies in patients with advanced melanoma. The trial failure hasn't shaken researchers resolve to move forward with the drug, though. The companies are saying that all of the data combined with the lack of options for patients should make a good case for approval. Investors weren't as confident, shaving about 18 percent off of Medarex's stock price on the news.

- see this release on the trial
- check out the AP report for more

ALSO: Kosan Biosciences also saw its stock price plunge after reporting that Phase Ib data for its blood cancer treatment tanespimycin appears to be worse than initially reported. Report

Related Article:
BMS misses a beat in cancer comeback. Report

Astellas inks $537M deal for Agensys

Tue, 27 Nov 2007 06:59:58 -0500

Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. The deal gives Astellas new antibody technology for combating cancer. Agensys has a Phase Ib trial underway for one antibody plus several more preclinical candidates. Astellas is betting that antibodies will play an ever-growing role in cancer treatments, which are expected to command a $32 billion market by 2015.

"Agensys will be the cornerstone of our biologics efforts and an integral component of building our oncology efforts within our franchise," explained Masafumi Nogimori, CEO of Astellas.

- see this release for more
- check out the report on the deal

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Synta outlines cash flow from Glaxo pact

Tue, 13 Nov 2007 06:59:56 -0500

Synta Pharmaceuticals' new, $1 billion pact with GlaxoSmithKline for the cancer drug elesclomol (code named STA-4783) is expected to open a spigot of cash for the drug developer. In its quarterly report, Synta says that Glaxo is expected to hand over milestone payments of $40 million to $50 million next year as the therapy advances in clinical trials. That's on top of the $80 million upfront provided by Glaxo.

"At the start of this year, we set an ambitious agenda for Synta in 2007: complete an initial public offering; initiate a global, pivotal trial for elesclomol; sign a major partnership agreement; initiate a Phase 1 trial for our Hsp90 inhibitor, STA-9090; and continue to build support for our oncology programs in the scientific community, including presenting survival data from our Phase 2b trial for elesclomol as well as mechanism of action and combination activity results," said Safi Bahcall, Ph.D., CEO of the Lexington, MA-based Synta. "I am pleased to say that we have successfully achieved each of these goals."

- check out the release for more info

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Memory's Alzheimer's drug aces Phase II

Fri, 02 Nov 2007 07:59:55 -0400

Memory Pharmaceuticals has announced a positive Phase II roof-of-concept trial of MEM 3454 in 80 patients with Alzheimer's disease over an eight week treatment period. The primary endpoint of the trial was the change from baseline in the Quality of Episodic Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR) battery. This is good news for Memory, which announced in mid-October that another drug, MEM 1003, failed a Phase IIa study.

"This data is consistent with our preclinical and Phase 1 results and reinforces our belief that MEM 3454 warrants continued development. We look forward to commencing our Phase IIa trial of MEM 3454 in cognitive impairment associated with schizophrenia in the near term."

- check out this press release for more

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ALSO NOTED: Renovis' CEO steps down; Isis gains $5M milestone; and much more...

Tue, 02 Oct 2007 06:59:50 -0400

> Chutes & Ladders: Corey Goodman is stepping down as CEO of Renovis as the company completes its planned merger with Evotec. Release

> Isis Pharmaceuticals has pocketed a $5 million milestone payment from partner Ortho-McNeil. Isis initialized a Phase 1 clinical trial of ISIS 325568, which triggered the payment. Release

> NicOx is touting the results of its collaboration with Spain's Ferrer Grupo International. In particular, the company is crowing about Phase I results for NCX 1022, a potential dermatology product. Release

> In an interview with Investor's Business Daily, Kevin Starr of VC firm Third Rock explains that a "giant void" has developed in biotechnology, with Big Pharma and VC firms looking to invest in late-stage products. Report

> Using mesenchymal stem cells taken from bone marrow, researchers at Massachusetts General Hospital have been able to spur the livers of rats to generate new tissue, raising the possibility that they can repair liver damage without resorting to a transplant. Report

> Counterfeit drugs and outright theft cost the pharmaceuticals industry some $71 billion a year, according to a new study from a consumer advocacy group known as America's Watchdog. Report

And Finally... A new approach to synthesizing natural compounds could significantly speed research and manufacturing processes for these therapeutics. Report

Roche halts Phase I trial

Fri, 21 Sep 2007 06:59:55 -0400

Roche has halted a trial of MAXY-alpha, also known as R7025, due to an unanticipated reduction of the pharmacodynamic and pharmacokinetic effects in patients who received the drug. Roche and development partner Maxygen are conducting Phase I trials of R7025 for Hepatitis C and Hepatitis B.

"We don't yet know how this will impact the future timing or advancement of the program. Roche has now started additional work to assess the meaning and significance of these results. We will provide an update once all relevant information is collected and evaluated," said Russell Howard, Maxygen's CEO. Back in March Roche opted out of another co-development deal with Maxygen for acute bleeding indications.

- see this release from Maxygen

Cancer therapy gets accelerated review at Exelixis

Thu, 23 Aug 2007 06:59:55 -0400

Exelixis and GlaxoSmithKline say they're hitting the gas on their program to develop XL880 as a "leading" MET inhibitor for cancer. Exelixis will review the therapy before proof-of-concept, accelerating Glaxo's decision on whether or not it will accept XL880 for further development and commercialization.

"We are extremely pleased that GSK has asked us to expedite its review process for XL880. This request reflects the high level of excitement around both the compound and the therapeutic potential of MET inhibition," said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. "Our recently reported data from the XL880 Phase 1 trial at the 2007 ASCO Annual Meeting underscore our belief that XL880 is the most advanced MET inhibitor in clinical development, and we and GSK are committed to building upon this leadership position."

- see the release from GSK

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ALSO NOTED: Rosetta expands U.S. operations; DOV announces Phase I results; and much more...

Fri, 10 Aug 2007 06:59:50 -0400

> Rosetta Genomics is expanding its U.S. operations. Release

> DOV Pharmaceutical announced Phase Ib results for DOV 21,947, its lead triple reuptake inhibitor for the treatment of depression and obesity. Release

> Pfizer is paring down its Ann Arbor campus. FiercePharma

> New insights into the way the brain operates are opening up a new therapeutic target to control fever as well as many of its symptoms like fatigue and loss of appetite. FierceBioResearcher

And Finally... J&J is suing the Red Cross. FiercePharma

KaloBios gains $20M in third round

Mon, 23 Jul 2007 06:59:56 -0400

KaloBios Pharmaceuticals has garnered $20 million in its third round, with much of that earmarked to advance its clinical development work. Lehman Brothers led the round with MPM Capital, Sofinnova Ventures, Alloy Ventures, 5AM Ventures, Singapore Bioinnovations, and Lotus BioScience Ventures taking part. Palo Alto, CA-based KaloBios has an ongoing clinical program for KB002 in rheumatoid arthritis. The company also recently initiated Phase 1 studies of KB001, which will be investigated for the treatment of Pseudomonas aeruginosa infections.

"We expect these new funds to support the development of our two lead product candidates, KB001 and KB002 into Phase II development, as well as the advancement of a third therapeutic program into clinical trials," said KaloBios CEO David Pritchard.

- here's the release for more information

ALSO: Nuon Therapeutics raised $5 million and named Ronald Pearlman, former CEO at Saegis, as its new CEO. Release

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Genaera abandons two studies in pipeline switch

Thu, 05 Jul 2007 00:01:38 -0400

Genaera has changed gears on its pipeline strategy after shuttering two mid-stage studies--one for Lomucin as a therapy for cystic fibrosis and the other for squalamine to treat prostate cancer. The Lomucin study was abandoned for "reasons of futility" while squalamine was shelved due to trouble restarting the cancer trial. Genaera will now focus on trodusquemine for obesity and the anti-IL-9 asthma program licensed to MedImmune.

"We continue to be very encouraged by the progress of the MEDI-528 Phase II program in asthma," said CEO Jack Armstrong. "This is an asset that is below the radar screen of many, and we believe has greater present and future value than is currently recognized by the market. Separately, our trodusquemine Phase 1 study in obesity is progressing nicely through the initial cohorts in Study 101 to test safety and PK.

- see the release
- check out the AP report

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Press Release: Sangamo BioSciences Announces Presentation of Phase 1 ZFP Therapeutic Data

Maureen Martino — Mon, 25 Jun 2007 10:07:30 -0400

Sangamo BioSciences Announces Presentation of Phase 1 ZFP Therapeutic Data at American Diabetes Association Meeting

CHICAGO, June 22 -- Sangamo BioSciences announced today the presentation of encouraging Phase 1 clinical data from its ZFP Therapeutic(TM) program at the 67th Scientific Sessions of the American Diabetes Association (ADA). As disclosed in an oral presentation entitled, "Improved Neurologic Exam and Nerve Conduction Velocities in Diabetic Neuropathy Patients Treated with Vascular Endothelial Growth Factor (VEGF) Zinc Finger Protein Activator (SB-509)," results of Sangamo's Phase 1b clinical trial demonstrated statistically significant improvements in subjects with diabetic neuropathy. SB-509 is a formulation of a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)) designed to upregulate the expression of the gene encoding vascular endothelial growth factor (VEGF-A). Sangamo is currently evaluating SB-509 in two ongoing Phase 2 clinical trials for the treatment of diabetic neuropathy.

"We are very excited by the significant improvements that we observed in several measurements of nerve health in subjects with mild to moderate diabetic neuropathy over six months after a single administration of SB-509," commented the presenter, Mark Kipnes, M.D., lead investigator on the Phase 1 trial and an endocrinologist at the Diabetes and Glandular Disease Clinic, San Antonio, Texas. "The data obtained in this clinical trial demonstrate that SB-509 appears to have not only a neuroprotective but possibly also a neuroregenerative effect. Currently, the only treatment options are analgesics and antidepressants to control pain symptoms. In contrast, SB-509 is designed to address the actual nerve damage and therefore could have a profound impact on the lives of patients suffering with diabetic neuropathy."

In addition, Sangamo announced today that two zinc finger nuclease (ZFN) pre-clinical therapeutic programs -- modification of the CCR5 gene in human primary T-cells for the treatment of HIV/AIDS and a novel therapy for the treatment of glioblastoma -- were reviewed and unanimously approved by the National Institutes of Health Recombinant DNA Advisory Committee (RAC) earlier this week. Sangamo filed applications for both programs with the RAC earlier this year, and a unanimous decision was made during the RAC's public review process which took place from June 19-21.

"This is an important step toward our goal of initiating Phase 1 clinical trials of both ZFP Therapeutic programs by the end of this year," said Edward Lanphier, president and CEO of Sangamo. "The fact that the RAC unanimously approved both programs is very gratifying and a testimony to the hard work and tireless preparation by the research and development groups at Sangamo."

Clinical Results Presented at ADA Conference

The data presented at ADA were collected from subjects with mild to moderate diabetic peripheral neuropathy enrolled in Sangamo's Phase 1b study of SB-509. Subjects received a single treatment in both legs of either placebo (6 subjects) or SB-509 (6 subjects who received 60 mg total dose or 30 mg per leg). All of the subjects completed 6-month follow-up testing. Clinicians observed statistically significant clinical improvements in quantitative sensory testing (QST) which quantifies perception of vibration and in nerve conduction velocity (NCV), a measure of the ability of a nerve to transmit an applied electrical signal. Specifically, mean QST testing compared to baseline in SB-509 treated patients showed a 42% improvement compared to 13% worsening in the placebo group and the mean sum of improvement of all lower extremity motor NCVs was 1.9 Meters/sec with SB-509 treatment compared to -2.3 Meters/sec with placebo. Clinicians also observed a trend for improvement in SB-509 treated patients in a composite measure of nerve health, the Total Neuropathy Score or TNS. The TNS is a comprehensive approach to evaluating changes in nerve health and includes assessment of several factors, including neurologic exam, QST, electrophysiologic studies and neurologic symptoms.

In addition, data were presented from a subject with a "blocked nerve" in the leg. "Blocked nerves" are nerves, that in response to electrical stimulus, have no measurable induced nerve conduction velocity or NCV but are still functional. Typically, diabetics with blocked nerves have more severe symptoms of neuropathy. Following a single treatment with SB-509, recovered and improved NCV were observed in this subject over a six-month follow-up period.

Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer, stated, "In addition to improvement in TNS and QST, three subjects in our Phase 1b study with 'blocked nerves' showed recovered and improved NCV during a six-month follow-up period after a single treatment with SB-509. This suggests that SB-509 may have a role in nerve regeneration, which is consistent with preclinical observations in a spinal cord paralysis model of statistically significant improvement in hind limb function. To further investigate and confirm this finding of a potential nerve regeneration activity of SB-509 in DN we have initiated a repeat-dosing, single-blind Phase 2 trial in subjects with moderate to severe DN."

From a safety perspective, the Phase 1b data were consistent with previous observations that a single treatment of SB-509 was well tolerated and that no severe adverse events were observed. Importantly, subjects in the study were treated within the pharmacologically effective dose range that was demonstrated to be efficacious in preclinical animal studies. Injection site reactions were the most common adverse events reported and were mild and reversible.

"We are pleased that our SB-509 diabetic neuropathy program Phase 1 update was selected for an oral presentation at the most significant US diabetes meeting of the year," said Edward Lanphier, Sangamo's president and CEO. "We believe that SB-509 represents a new therapeutic approach for diabetic neuropathy, designed to directly protect and possibly restore nerve function, in contrast to the current standard of care designed to address the pain associated with this condition. We expect to provide an additional update on the progress of this trial later in the year. We are encouraged by the data so far and are swiftly moving forward to the next stage of clinical development with our two ongoing Phase 2 clinical trials."

About the SB-509 Clinical Program

SB-509 is an injectable formulation of plasmid DNA that encodes a ZFP TF, designed to upregulate the VEGF-A gene.

Phase 1

Phase 1b study to assess the safety and clinical effects of a single administration of SB-509 to subjects is ongoing. Subjects were randomized and administered either SB-509 or placebo in both legs by intramuscular injection. Two dose levels of SB-509 have been tested. At the first dose level, three subjects were administered placebo and three subjects were treated with a total of 30 mg of SB-509, 15 mg per leg. Accrual of these subjects is complete. A further twenty-two subjects have been treated at the second dose level with either placebo or a total dose of 60 mg of SB-509, administered as 30 mg per leg. Subjects in this Phase 1b study will be monitored for both the safety and tolerability of SB-509 treatment as well as evaluation of pain and clinical effects on lower limb diabetic neuropathy at one, two, three and six months post-treatment.

Phase 2

Sangamo has two ongoing Phase 2 studies in diabetics with sensory/motor neuropathy:

Phase 2 study of SB-509 for mild to moderate DN

The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites.

Approximately 100 subjects will be enrolled into the trial. Subjects will be randomized to one of two groups in a 2:1 ratio. The larger group (approximately 66 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 2 months. The remaining group (approximately 33 subjects) will receive an equal volume of placebo on the same schedule. Each subject will receive a total of three treatments (Day 0, 60 and 120). Subjects will receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

The symptoms of diabetic peripheral neuropathy and any changes that occur during the trial will be evaluated based on neurological examination data, electrophysiological testing data, subject neurological questionnaire, and subject pain assessment. Specifically, investigators will use the following tests: the visual analog scale for pain intensity (VASPI), total neuropathy score (TNS) to assess signs and symptoms of the condition. A composite scoring system is widely regarded by neurologists as the most comprehensive approach to evaluating changes in nerve health. In addition to qualitative assessment of symptoms, the TNS includes electrophysiological testing using nerve conduction velocity (NCV) to assess the rate at which a nerve can conduct an electrical signal, and quantitative sensory testing (QST) with the Vibratron II instrument, to assess the threshold of detection of vibration. In addition, skin biopsies will be taken to evaluate the direct therapeutic effect of SB-509 on nerve regrowth. This test is a very sensitive marker of DN severity and may provide an important mechanistic marker for efficacy.

The trial is expected to take approximately 12 months to screen and enroll subjects, four months for subject treatment and a further 8 months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.gov/ or the Sangamo website at http://www.sangamo.com/.

Phase 2 study of SB-509 for moderate to severe DN

The clinical trial is a single-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with moderate to severe diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites.

Approximately 45 subjects will be enrolled in the trial. Subjects will be randomized to one of two groups in a 2:1 ratio. The larger group (approximately 30 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 3 months. The remaining group (approximately 15 subjects) will receive an equal volume of placebo on the same schedule. Each subject will receive a total of two treatments (Day 0 and 90). Subjects will receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

For each subject the trial is expected to take approximately fourteen months: two months for screening, three months for subject treatment and a further nine months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.gov/ or the Sangamo website at http://www.sangamo.com/.

About SB-509

SB-509 is administered as an injectable formulation of plasmid DNA that encodes a ZFP TF, designed to upregulate the VEGF-A gene. VEGF-A has been demonstrated to have direct neurotrophic and neuroprotective properties. In preclinical animal efficacy studies in a diabetic rat model (Diabetes, June 1, 2006; 55(6): 1847-1854), SB-509 has proven effective in protecting motor and sensory nerve function from disease-induced nerve damage.

About Diabetic Neuropathy

Diabetic peripheral neuropathy is one of the most frequent complications of diabetes. Symptoms include numbness, tingling sensations and pain particularly in the toes or feet. This gradually evolves to loss of sensation and motor function as nerve damage progresses. Ulcers and sores may appear on numb areas of the foot because pressure or injury goes unnoticed. Despite adequate treatment, these areas of trauma frequently become infected and this infection may spread to the bone, necessitating amputation of the leg or foot. More than 60 percent of non-traumatic lower-limb amputations in the United States occur among people with diabetes. In the period from 2000 to 2001, this translated to approximately 82,000 amputations. The American Diabetes Association estimates that there are approximately 20.8 million people with diabetes in the United States and that of those about 60 percent to 70 percent have mild to severe forms of neuropathy. According to the Centers for Disease Control, diabetes is becoming more common in the United States. From 1980 through 2002, the number of Americans with diabetes more than doubled.

About Sangamo

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on cancer and HIV/AIDS, neuropathic pain, nerve regeneration, ischemic heart disease and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company's web site at http://www.sangamo.com.

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the clinical trials of SB-509, research and development of novel ZFP TFs and ZFNs and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the initiation and completion of stages of the SB- 509 clinical trials, whether the SB-509 clinical trials will validate and support tolerability and efficacy of SB-509, technological challenges, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent 10-Q. Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking information contained in this press release.

Press Release: Adnexus Therapeutics Announces Presentation of Phase I Results for CT-322

Maureen Martino — Fri, 02 Feb 2007 12:54:00 -0500

Adnexus Therapeutics Announces Presentation of Interim Phase I Results for CT-322, First Adnectin Therapeutic in Humans

WALTHAM, Mass. -- Feb 2, 2007 - Adnexus(TM) Therapeutics, Inc. today announced interim results of an ongoing Phase 1 open-label, dose-escalation study of its novel anti-angiogenic biologic, CT-322, in patients with advanced cancers. These results were presented at the 9th International Symposium on Anti-Angiogenic Agents in San Diego, CA by Anthony W. Tolcher, M.D., FRCP of the Institute for Drug Development Cancer Therapy and Research Center in San Antonio, Texas. CT-322 is a proprietary Adnectin(TM) protein therapeutic that, in preclinical studies, specifically binds to vascular endothelial growth factor receptor 2 (VEGFR-2), which regulates the primary tumor angiogenesis pathway. As a result, CT-322 blocks all known ligands for VEGFR-2.

The phase 1 study was designed to assess the safety, tolerability, and pharmacokinetics of CT-322 in cancer patients, as well as to evaluate preliminary evidence of biological and antitumor activity. The maximum tolerated dose has not yet been reached.

CT-322 demonstrated promising evidence of biological activity in patients within four hours of drug administration as evidenced by elevated plasma levels of biomarkers of VEGFR-2 pathway, and these biomarkers remained elevated significantly above baseline throughout the multi-dose treatment period. In addition, CT-322 administration resulted in predictable, consistent pharmacokinetics that could support every-other-week dosing in humans.

"These initial results are very encouraging both for CT-322 as well as for the Adnectin class," commented Dr. Tolcher. "CT-322 has the potential to become an important cancer therapeutic due to its unique mechanism of action. More broadly, the emergence of a new category of drugs with such broad potential is rare and is very exciting for the clinical community."

"The first administration of an investigational Adnectin therapeutic to people, along with highly favorable and consistent drug properties that were observed in humans, propels our novel class of biologics ahead of other new targeted biologics paradigms such as siRNA, aptamers, nanobodies and other new antibody based approaches," commented John Mendlein, Ph.D., CEO of Adnexus Therapeutics. "Our preliminary human data for CT-322 support competitive drug-like qualities for the Adnectin class in many therapeutic areas. As a leader among companies developing new biologics, we believe medicines based on our Adnectin product class represent the next wave of vital medicines."

About CT-322

CT-322 specifically inhibits VEGFR-2 activation by its ligands VEGF-A, VEGF-C, and VEGF-D. In preclinical studies, this cell-surface receptor drives angiogenesis (growth of new blood vessels) in solid tumors, and CT-322 inhibits the tumorgenic effect of VEGFR-2 in preclinical models. CT-322 was designed using the PROfusion(TM) System, Adnexus' patented product design engine.

About the New Adnectin Product Class and the PROfusion System

Adnectins are an emerging protein therapeutic class that can be designed to treat a broad range of diseases. They are based on human fibronectin, an extracellular protein that is naturally abundant in human serum. The intrinsic properties of an Adnectin align with properties of successful drugs, including high potency, specificity, stability, favorable half life, favorable IP profile and high yield E. coli production.

Adnectins are designed using the PROfusion System, Adnexus' patented protein design engine, to achieve high potency and specificity for a therapeutic target while simultaneously selecting for ideal pharmaceutical product characteristics. PROfusion enables Adnexus to screen over 1 trillion unique Adnectins for each drug discovery program to "redirect" naturally occurring human fibronectin to act as a protein therapeutic. This greatly accelerates Adnectin drug discovery and development.

Adnexus is the exclusive developer of Adnectins. Adnexus solely owns the Adnectin patent estate that controls issued and pending patent properties to fundamental Adnectin forms. In addition, Adnexus exclusively controls its patented PROfusion protein design engine. Adnexus has over 100 issued and pending patent properties relating to Adnectins and PROfusion.

About Adnexus Therapeutics

Adnexus Therapeutics is focused on generating vital medicines through the discovery, development, and commercialization of its broadly applicable new therapeutic class, Adnectins. Adnexus' lead product candidate, CT-322, is in Phase 1 clinical development in oncology in the United States. The company also has a pipeline of other Adnectin products in preclinical research across multiple therapeutic areas. Adnectins are designed and optimized using PROfusion, the company's patented protein design engine that uniquely enables rapid optimization of protein therapeutics. The company is funded by four leading venture capital firms: Atlas Venture, Flagship Ventures, Polaris Venture Partners, and Venrock Associates.

This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the timing of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not obtain approval to market its products.

Adnectin(TM), Adnexus(TM) Therapeutics and PROfusion(TM) are trademarks of Adnexus(TM) Therapeutics, Inc. Adnexus(SM) Therapeutics is a service mark of Adnexus(TM) Therapeutics. For more information, please visit www.adnexustx.com

Press Release: AmpliMed Secures $8.5 Million in Additional Series B Financing

Maureen Martino — Mon, 27 Nov 2006 12:51:04 -0500

AmpliMed Secures $8.5 Million in Additional Series B Financing

Oncology Drug Development Company to Use Funds to Achieve Milestones in Clinical Development

TUCSON, Ariz.-- AmpliMed® Corporation today announced a second closing of its Series B Preferred private placement of $8.5 million, raising the total invested in the round to approximately $14.6 million. The Series B was led by Biotech Insight Ventures and included InvestBio Ventures, Valley Ventures and Solstice Capital, all of whom were previous investors. To date, AmpliMed has raised more than $24 million in financing.

“AmpliMed continues to achieve significant milestones in the development of its anticancer drugs,” said Joel R. Smolen, Managing General Partner at Biotech Insight Management, L.L.C., which manages Biotech Insight Ventures L.P. “We are very excited about the Company’s accomplishments over this past year and look forward to the outcomes of several key clinical trials in melanoma and pancreas cancer scheduled to be completed early next year.”

AmpliMed’s multi-center studies using a combination of Amplimexon® and common chemotherapeutic agents in Stage IV metastatic melanoma (Phase II) and advanced pancreatic adenocarcinoma (Phase Ib) are scheduled to be completed early next year. An additional trial in patients with breast, lung and prostate cancer is also underway.

“Our investors’ support underscores their commitment to our clinical development program and our growing pipeline of anticancer therapies,” said Robert A. Ashley, Chairman, President and Chief Executive Officer of AmpliMed. “These new funds will enable us to complete our current Phase I and II trials of Amplimexon and position the Company to launch into the next phase of our clinical development program.”

About Amplimexon

Amplimexon is the name of AmpliMed’s formulation of imexon for injection. Imexon is a cyanoaziridine compound which showed tantalizing evidence of activity in limited studies in lung cancer, melanoma and breast cancer that were documented in publications in the 1980s. The potential of imexon as a cancer drug was never fully explored, until 1994, when AmpliMed co-founding scientists Drs. Evan Hersh, David Alberts, Robert Dorr and William Remers initiated a program to decipher Amplimexon’s novel mechanism of action. This led to the initiation in 2003 of a Phase I clinical study of the drug as a stand-alone therapy in late-stage cancer patients. Further preclinical research revealed that the combined use of Amplimexon and certain other chemotherapeutics resulted in a significant increase in efficacy compared to either drug alone. These findings are now being translated into a series of Phase I/II clinical studies of combination therapy in patients with various types of cancer.

About AmpliMed Corporation

AmpliMed Corporation was founded in 1989 with the support of the University of Arizona Technology Development Corporation and is focused on the clinical development of chemotherapeutic agents for cancer. AmpliMed’s strategy is to develop anti-cancer drugs with novel mechanisms of action designed to overcome some of the limitations, such as myelosuppression (suppression of blood cell counts), multi-drug resistance (treatment-induced resistance to many cancer drugs) and cardiac toxicity, frequently associated with current cancer therapy. The company’s lead product, Amplimexon (imexon for inj.), is in Phase II clinical trials. Other products in the company’s portfolio include benzimate which entered the clinic in 2006, Amplizone™, expected to enter the clinic in 2007, and a portfolio of derivatives of each of the lead compounds for future development. AmpliMed Corporation is based in Tucson, Arizona and is on the Web at http://www.amplimed.com.

Press Release: Organon continues with the development of asenapine

Maureen Martino — Mon, 27 Nov 2006 12:25:08 -0500

Organon continues with the development of asenapine

Tuesday, November 28, 2006 (Arnhem, The Netherlands)

Organon has decided to continue with the development of asenapine. This follows on from the decision taken by Organon and Pfizer to discontinue their collaboration in the further development of asenapine, a new drug candidate for the treatment of schizophrenia and acute mania associated with Bipolar I Disorder.

The results of the final Phase III clinical trial with respect to schizophrenia, which were recently received, were positive. This is in addition to the previous positive data on safety and tolerability for this indication. Organon will now assess if further clinical trials are necessary. Organon has data on efficacy, safety and tolerability for the treatment of Bipolar I Disorder and the positive data on the treatment of schizophrenia.

Pfizer’s decision to discontinue its participation in the asenapine development program is an outcome of a commercial analysis of the compound as a part of its overall portfolio.

The interim assessment of the Phase III trial results made available in October led to the caution that the results might not be sufficiently conclusive to warrant an NDA filing with the FDA in 2007. This has not changed.

Toon Wilderbeek, the Akzo Nobel Board member responsible for Pharma, who is also President of Organon, said today: “The satisfactory results of the final Phase III clinical trial – in the context of the complete Phase III clinical trial data set for asenapine – is an important milestone in the development of asenapine. We have now completed a crucial phase of the program and we will assess if further trials might still be required in order to be able to submit a strong NDA file.“

He continued: “We are pleased to now have the opportunity to pursue a go-to-market strategy for asenapine which is more closely aligned with our planning and positioning for this product candidate. We will evaluate whether we need a partner to commercialize asenapine in selected geographic areas in due course. Although Organon is disappointed with the withdrawal, the company appreciates the positive contribution Pfizer has made to the development of asenapine.”

Willem de Laat, Organon’s Executive Vice-President Medical Affairs, added: “Patients treated for schizophrenia and bipolar disorder are frequently faced with significant unmet needs. Compliance remains an issue for the majority and many switch to other medication for a variety of reasons – including tolerability, side effects and administration forms. Therefore it is important to offer other options that address a patient’s real-life needs and that will bring relief to those seeking alternative treatment.”

The Phase III trial program for the initial NDA submission consisted of schizophrenia and bipolar mania trials involving more than 2,000 and 950 patients, respectively. Asenapine, a fast-dissolving, novel psychopharmacologic agent with a unique human receptor signature, was shown to be effective in two out of four short-term schizophrenia studies, two short-term bipolar mania studies with a nine- week extension. One schizophrenia study failed (both asenapine and the active comparator did not differentiate from placebo) and one study was negative for asenapine on its primary endpoint (asenapine did not discriminate at end point from placebo, while the active comparator did).

The safety profile of asenapine, derived from a long-term 1,200 patient safety study and efficacy studies, is in line with the profile as found in phase II studies, i.e. minimal effects on weight gain, QTc, metabolic parameters and liver parameters, and is considered to be adequate for the treatment of schizophrenic and bipolar patients. Details of the efficacy and safety results will be communicated during scientific meetings in due course.

Pfizer will return all product rights, intellectual property and data to Organon and make orderly transitions during 2007.

Somaxon touts latest Phase III results for Silenor

Sun, 19 Nov 2006 19:01:34 -0500

Another Phase III trial of Somaxon's insomnia drug Silenor has produced more data supporting its statistically significant results in patients. In a late-stage trial of 255 elderly volunteers with a minimum three-month history of insomnia, the drug met its primary and secondary endpoints. The primary endpoint was total sleep time. Silenor also proved a winner in a Phase III trial last April. Somaxon was a 2005 Fierce 15 company.

"With this positive Silenor data we are nearing completion of our Phase III clinical development program. We look forward to the results of our final Phase III clinical trial, which we expect in December, the continuation of ongoing strategic collaboration discussions and a New Drug Application filing targeted for the third quarter of 2007."

- see the release on the trial results

Related Article:
Somaxon touts mid-stage data on smoking cessation. Report

ALSO NOTED: Lilly reports positive Arxxant data; Favrille drug misses secondary goal; and much more...

Sun, 12 Nov 2006 19:01:30 -0500

> Eli Lilly has released late-stage data showing that Arxxant reduces the loss of vision from diabetes by 40 percent. Report

> Favrille says its experimental therapy for non-Hodgkin's lymphoma missed a secondary endpoint but that researchers are still examining its results for a primary endpoint in a late-stage trial. Report

> Shares of the UK's SR Pharma surged on the news that early testing on an RNAi therapy delivered encouraging results. Report

> A Maryland biotech upstart has garnered $4 million in angel backing to launch its commercial work in developing a new stem cell therapy for cardiology. Report

> ZymoGenetics and Serono released positive data from their Phase Ib trial of atacicept for lupus. Release

> Shares of Denmark's LifeCycle Pharma jumped 10 percent during its market debut. Report

> Nordic Biotech and pSivida have inked a $26 million pact for funding the eye therapy Medidur. Release

> The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. Report

> Pharmaceutical industry vendors are suing to get a New Hampshire law thrown out which they claim unconstitutionally restricts their use of physician-identifiable prescription information. Report

And Finally... One in three U.S. hospitals, including top cardiac centers, do not follow recommended procedures in caring for heart attack victims. Article