tumors

Avant shares soar on positive cancer vaccine data

Tue, 03 Jun 2008 06:59:57 -0400

On the same day that Ted Kennedy was undergoing brain surgery to remove a tumor, researchers were pouring over new data for an experimental cancer vaccine designed to combat glioblastoma multiforme tumors. In a small study directed by Duke University's John Sampson, 23 patients appear to be on track to deliver a median overall survival rate of 33.1 months where the historical median is 14.3 months. Pfizer obtained the license for CDX-110 earlier this year from Avant Immunotherapeutics, which saw its stock price soar 34 percent on the news.

"So far it's encouraging to see ACT II replicate Activate, and basically double both time-to-progression and (projected) overall survival in comparison to the historical control," said Brean Murray & Co. analyst Jonathan Aschoff.

- see Avant's release
- read the AP report
- check out the story from Forbes

Biotechs merge to form Aduro BioTech

Tue, 03 Jun 2008 06:59:54 -0400

Berkeley, CA-based Oncologic has merged with Triton BioSystems into a new developer named Aduro BioTech. The combined biotech will focus on developing iron oxide nanoparticles to attack solid tumors. The particles are heated by a magnetic field, killing tumor cells. A spokesman for Aduro told the San Francisco Business Times that Dartmouth researchers will handle much of the early research work. Stephen Isaacs, who founded Cerus, is CEO of Aduro, which has a staff of nine. The report says Aduro has completed a first round of venture capital but declined to say how much money was raised.

- see the merger release
- read the story in the San Francisco Business Times

SPOTLIGHT: $1B program catalogs cancer triggers

Tue, 29 Apr 2008 06:59:53 -0400

An international consortium of researchers has launched a billion-dollar effort to map every way that changes in DNA contributes to the development of tumors. The newly launched International Cancer Genome Consortium says that they hope to complete their work in less than 10 years as they ambitiously map out a project that is being described as the cancer equivalent of the Human Genome Project. Report

SGX shares slide on report of early-stage toxicity

Thu, 27 Mar 2008 07:59:58 -0400

Shares of SGX Pharmaceuticals were sliding this morning on the news that its lead cancer therapy produced unexpected dose-limiting levels of toxicity in early-stage trials. The company said that it was surprised by the toxicity in SGX523 after a careful evaluation of animal data revealed no such tendency. And company officials carefully noted that they're examining other dosing regimens while pursuing the development of additional cancer therapies in its pipeline.

Patients in a low-dose trial of SGX523 involving solid tumors continue to be treated while no further dosing is being provided in an interrupted dosing trial--a repeating 21 day cycle of 14 days on therapy followed by 7 days off.

"From the initial clinical data, the profile of SGX523 appears to be different than the preclinical data would suggest," said Mike Grey, president and chief executive officer of SGX Pharmaceuticals. "We may explore whether alternative doses and schedules are safe and efficacious. We continue the preclinical development of the BCR-ABL inhibitor SGX393 and the second MET inhibitor SGX126. In addition, we are targeting the identification of two development candidates this year from our drug discovery programs to further enhance our pipeline."

- check out the press release

Related Articles:
SGX Pharmaceuticals--Best Pharma Stocks of 2007. Report
SGX Initiates Phase I Trials for SGX523. Report
SGX shares tank on late-stage trial failure. Report

Pfizer snaps up Serenex in buyout

Mon, 03 Mar 2008 06:59:58 -0500

Pfizer has beefed up its prospects in the cancer arena with today's buyout of Durham, NC-based Serenex. The biotech has been developing drugs for tumors and cancers of the blood and bone marrow. But Pfizer also acquires--for an undisclosed sum of money--the company's drug discovery technology.

Serenex has raised about $81 million in venture funds to advance technology developed at Duke University. The biotech has one drug, SNX-5422, an oral Hsp90 inhibitor, in early-stage development.

- see this release for more
- check out the AP report
- here's the Dow Jones story

Related Articles:
Serenex banks $31M in latest venture round. Report
Serenex raises $30M in second venture round. Report
Speculation soars over Pfizer's interest in biotech. Report
Pfizer's future rests with biotech. Report

Novocell reports breakthrough in diabetes cure

Thu, 21 Feb 2008 06:59:57 -0500

Researchers at Novocell report a key breakthrough in their program to find a cure for diabetes. The company reports that the researchers were able to turn embryonic stem cells into insulin-producing cells in mice. And after the mice's insulin-producing cells had been destroyed, the new cells kept their blood sugar levels in check.

"For those who say there is not much evidence that embryonic stem cells can cure diabetes, there you go," Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami told The New York Times. Dr. Ricordi was not involved in the research program. The research did raise red flags, though. Some of the mice in the study developed tumors and there were questions raised whether the cells were characterized well enough for use in humans. Human trials are still several years away.

- read the article in The New York Times

Related Articles:
Novocell garners $25M for stem cell work. Report
Novocell scientists create insulin-producing cells. Report
ESC therapies in race to the clinic. Report

Mixed data from two Threshold cancer trials

Fri, 18 Jan 2008 06:59:55 -0500

California-based Threshold Pharmaceuticals has released an update on its glufosfamide program. According to the company's release, a Phase II trial of the drug for soft tissue sarcoma "provided evidence of clinical activity." Threshold will continue trials of the drug for this indication, but said that dosing will have to be adjusted in later studies. The news was not so good from the ovarian cancer trial. The company has decided to drop glufosfamide due to a lack of efficacy and enrollment challenges.

In October, Threshold cut its staff and expenses after reporting disappointing data from Phase II trial of glufosfamide for small cell lung cancer. The drug is also undergoing Phase III trials for pancreatic cancer, and is in Phase I trials for the treatment of solid tumors.

- see this release from Threshold for more

Related Articles:
Threshold slashes staff in effort to cut burn rate. Report
Threshold halts lung cancer study. Report
Threshold delays release of glufosfamide analysis. Report
Threshold slashes staff in wake of quarterly loss. Report
Threshold shares drop after Phase III suspension. Report

Idera shares surge on Merck KGaA pact

Wed, 19 Dec 2007 06:59:58 -0500

Idera is pocketing a $40 million up front fee from Merck KGaA and hopes to make an additional $381 million in milestones from licensing its technology for cancer therapies. The German Merck gains exclusive rights to Idera's two most advanced Toll-like Receptor 9 (TLR9) agonists for cancer--IMO-2055 and IMO-2125--for all uses with the exception of cancer vaccines. These Toll-like receptors are sentinels for chemicals in pathogens for cancer, infectious diseases, respiratory and autoimmune disorders. IMO-2055 has been involved in Phase I studies for solid tumors that have been unresponsive to standard therapy. Shares of Idera surged on the news.

- see the release
- here's the AP's report on the deal

Related Articles:
Idera inks $455M pact for Merck vaccines. Report
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Merck KGaA buying control of Serono. Report

Delcath shares hammered on trial enrollment suspension

Tue, 23 Oct 2007 06:59:57 -0400

Shares of Delcath Systems went into free fall this morning, losing about two thirds of their value after the company announced that regulators from the FDA asked researchers to temporarily suspend enrollment for Phase II and Phase III trials of a delivery system used for treating liver cancer. The FDA wants to see an analysis on side effects before it meets with Delcath to discuss safety concerns. Two deaths were among the four serious adverse events reported from a late-stage study. The trials involved the use of the Delcath System with a drug used to treat tumors in the liver. Patients already enrolled in the trial will continue to be treated.

"We are prepared to meet with the FDA as soon as possible, and will present a thorough analysis of these GI episodes. We will update our investors promptly on resolution of this issue," said Richard L. Taney, president and CEO of Delcath.

- check out the release
- here's the AFX report for more

Introgen reports biomarker link to new therapy

Thu, 27 Sep 2007 06:59:55 -0400

Introgen Therapeutics says that their researchers have found a statistically significant link between an abnormal p53 biomarker and response to their experimental therapy for head and neck cancer. The researchers plan to use that knowledge in analyzing data from a late-stage trial of Advexin. The company had already amended its INDA to include an analysis of the response to the drug by patients with the abnormal p53 biomarker. According to Introgen: "Tumor response after Advexin monotherapy was observed in 35 percent of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group. The majority of these patients had recurrent disease after receiving standard therapies."

- see the release on the data

Related Articles:
Introgen touts cancer data. Report
Reactivated p53 gene plays role in fighting tumors. Report

SPOTLIGHT: Hollis-Eden skyrockets on preclinical cancer data

Fri, 07 Sep 2007 06:59:53 -0400

At the 2007 ASCO Breast Cancer Symposium, Hollis-Eden reported impressive data for HE3235, a preclinical candidate for breast cancer. HE3235 significantly inhibited the incidence of new tumors and stopped the growth of existing tumors in a preclinical model of breast cancer. The company's stock shot up 30 percent on the news. Last week, Hollis-Eden was featured in FierceBiotech's weekly series on emerging drug developers. Release

Adnexus outlines $86M IPO to advance adnectins

Wed, 22 Aug 2007 06:59:57 -0400

With its lead therapy poised to begin mid-stage trials early next year, Adnexus Therapeutics has filed papers with the SEC for an IPO designed to raise $86.3 million. The company is developing adnectins, which relies on a protein engineering system. Angiocept, its lead adnectin, has been in an early stage study to prevent the formation of blood vessels in tumors. And most of the money is hopes to raise on the market would fund that trial and other pipeline studies. Adnexus--which is in a partnership with Bristol-Myers Squibb, says that it lost $11.9 million in the first half of this year.

- see the release form Adnexus
- check out the AP report for more info

Related Article:
Adnexus raises $15.5M. Report

FDA approves Enzon's IND for cancer therapy

Thu, 25 Jan 2007 19:01:34 -0500

The FDA has approved Enzon Pharmaceuticals' IND for its HIF-1 alpha antagonist for various cancer types, including common solid tumors. The company plans to initiate a Phase I trial in the first half of 2007. "This marks an important milestone for Enzon as we continue to focus our efforts on important oncology therapies," said Jeffrey Buchalter, chairman and chief executive officer of the company. "The continued advancement of the HIF-1 alpha program demonstrates our commitment to developing a differentiated cancer portfolio."

- check out the press release for more

ALSO: Denmark's Santaris Pharma won a $5 million milestone from the acceptance of the IND. Release

Related Articles:
Santaris inks $200M collaboration with Enzon. Report

Press Release: Molecular Insight Pharmaceuticals Acquires Drug Candidate From Bayer Schering Pharma

Maureen Martino — Wed, 17 Jan 2007 11:46:25 -0500

Molecular Insight Pharmaceuticals Acquires Malignant Melanoma Radiotherapeutic Drug Candidate From Bayer Schering Pharma

CAMBRIDGE, Mass. -- Molecular Insight Pharmaceuticals, Inc. announced today that it has entered into a worldwide, exclusive licensing agreement with Bayer Schering Pharma to acquire ZK-BA, a compound in development for the treatment of malignant melanoma. ZK-BA (Solazed(TM)) joins Azedra(TM) (Ultratrace(TM) iobenguane I 131) and Onalta(TM) (an yttrium-90 radiolabeled somatostatin peptide analog) in Molecular Insight's portfolio of targeted radiotherapeutic product candidates.

Under terms of the agreement, Molecular Insight Pharmaceuticals will pay Bayer Schering Pharma a licensing fee and additional payments upon completion of certain regulatory milestones, with royalties payable to Schering upon commercialization of the product. Further terms of the agreement were not disclosed.

Solazed is a proprietary, small molecule, benzamide compound that targets melanin, an oxygenated form of the amino acid tyrosine, which is over-expressed in approximately 40 percent of melanoma tumors. The compound can be labeled with Iodine-131 for use as a targeted radiotherapeutic and with Iodine-123 for imaging. In preclinical studies in xenograft mouse models, Solazed demonstrated a reduction in tumor volume and a survival benefit. The compound has also been evaluated in a small, investigator sponsored trial in Europe in which the compound displayed significant and prolonged accumulation in melanoma tumors.

There are approximately 48,000 new cases of melanoma in the United States annually and about 15,000 deaths. Molecular Insight plans to develop Solazed initially for patients with advanced disease.

About Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve patient healthcare by addressing significant unmet needs. The company is focused on discovering, developing and commercializing innovative and targeted radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Molecular Insight's lead radiotherapeutic product candidates, Azedra and Onalta, are under development for the treatment of cancer. The company's lead molecular imaging pharmaceutical product candidate, ZemivaTM (iodofiltic acid I 123), is in development for the diagnosis of cardiac ischemia, an insufficient blood flow to the heart. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts. The company's website is: www.molecularinsight.com.

Contact: Molecular Insight Pharmaceuticals, Inc. Priscilla Harlan, 617-492-5554 Vice President, Corporate Communications

SPOTLIGHT: Progen axes royalty pact

Mon, 15 Jan 2007 19:01:33 -0500

Progen Industries has killed a pact to share royalties on the experimental tumor drug PI-88, believing it can gain greater value for the therapy as it moves into late-stage trials. Terminating the agreement with Taiwan's Medigen could cost Progen more than $15 million. Medigen will lose its rights to 15 percent of the royalties from PI-88, in exchange for shares, options and some cash. Report

SPOTLIGHT: Genentech licenses Exelixis therapy

Tue, 02 Jan 2007 19:01:33 -0500

Genentech and Exelixis have agreed to a global development pact for XL-518, an MEK-inhibitor for tumors. Exelixis stands to gain up to $40 million in milestones and an upfront fee. Exelixis is responsible for Phase I development. Release

Press Release: Telik Reports Preliminary Results on Phase 3 Clinical Trials

Maureen Martino — Tue, 26 Dec 2006 12:23:41 -0500

Telik Reports Preliminary Results on ASSIST-1, ASSIST-2 and ASSIST-3 Phase 3 Clinical Trials

PALO ALTO, Calif., Dec. 26 -- Telik, Inc. announced preliminary results from three separate Phase 3 clinical trials of its investigational drug TELCYTA (TLK286, canfosfamide HCl).

Non-Small Cell Lung Cancer

ASSIST-2 Trial

The ASSIST-2 trial, a 520 patient multinational, randomized study designed to evaluate TELCYTA as compared to gefitinib in the third-line therapy of advanced non-small cell lung cancer, did not achieve a statistically significant improvement in overall survival, the primary endpoint.

Platinum Refractory or Resistant Ovarian Cancer

ASSIST-1 Trial

The ASSIST-1 trial, a 440 patient multinational, randomized study designed to evaluate TELCYTA as compared to the active control agents liposomal doxorubicin or topotecan in the third-line therapy of platinum resistant ovarian cancer, did not achieve its primary endpoint of demonstrating a statistically significant improvement in overall survival for TELCYTA as compared to the active controls. While the preliminary analysis revealed a number of internal inconsistencies that need to be further investigated, resolution of these inconsistencies may not change the preliminary results.

ASSIST-3 Trial

The ASSIST-3 trial, a 244 patient randomized trial conducted in the U.S., was designed to demonstrate a statistically significant improvement in overall tumor response to the combination of TELCYTA plus carboplatin compared to liposomal doxorubicin in the second-line treatment of platinum resistant ovarian cancer. Under the trial protocol, patients were to have received treatment until tumor progression or unacceptable toxicity. However, a major discordance was observed between the clinical review of the tumor scans and the independent radiology review. Approximately 25% of the patients were discontinued prematurely from the assigned study treatment as judged by the independent review of the scans. Therefore, the company believes the trial was compromised and may not be suitable for a regulatory submission. The company plans to meet with advisors to review the results and also to determine if any changes should be made to the protocol and/or trial conduct procedures for the ongoing ASSIST-5 trial.

Objective tumor responses were observed on the investigational arms containing TELCYTA in all three trials based on the prospective central blinded independent radiology review.

TELCYTA Safety

Preliminary analysis of the safety data from the ASSIST-1 and ASSIST-2 TELCYTA monotherapy trials indicates that TELCYTA was, as expected, generally well-tolerated. TELCYTA treatment was associated with mild to moderate nausea, vomiting and fatigue, mostly Grade 1 or 2. There were few Grade 3 or Grade 4 toxicities observed among the TELCYTA-treated patients on the ASSIST-1 and ASSIST-2 trials. Preliminary analysis of the safety data from the ASSIST-3 trial, combining TELCYTA plus carboplatin, demonstrated toxicities expected of each drug alone and no unexpected or cumulative toxicities were reported.

"We acknowledge and thank the patients and investigators who participated in these trials, and the entire Telik team for their efforts," said Michael Wick M.D., PhD Chairman and Chief Executive Officer. "These results are extremely disappointing. We are conducting additional, detailed analyses of the data from these three trials and plan to discuss those results with our advisors to determine the next development steps. We plan to present data from these trials at a scientific meeting."

Conference Call and Webcast

Telik management will host a conference call to discuss the ASSIST trial results today at 8:30 am Eastern time (5:30 am Pacific time). To access the conference call by telephone, contact 800-230-1085 or 612-332-0228. The conference call will also be available via webcast on the Telik website, www.telik.com . The archived webcast and teleconference replay will be available approximately 2 hours after completion of the event through January 9, 2007. The replay will be available by telephone at 800-475-6701 or 320-365-3844, access code 857115.

About Telik

Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on discovering, developing and commercializing novel small molecule drugs to treat serious diseases. The company's most advanced drug development candidate is TELCYTA, a prodrug believed to be activated within cancer cells. A second drug development candidate, TELINTRA(TM) (TLK199), is in clinical development in myelodysplastic syndrome. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(TM), which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com .

This press release contains "forward-looking" statements, including statements regarding the potential for TELCYTA to treat one or more types of cancer. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, that none of Telik's product candidates have been determined to be safe or effective in humans or been approved for marketing, and ongoing clinical trials of Telik's product candidates may take several years to complete and may not be successful. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its quarterly report on Form 10-Q for the quarter ended September 30, 2006. Telik does not undertake any obligation to update forward-looking statements contained in this press release.

Press Release: Helsinn to Discontinue Becatecarin Trial Program

Maureen Martino — Mon, 20 Nov 2006 11:51:38 -0500

Helsinn to Discontinue Becatecarin Trial Program

SOUTH SAN FRANCISCO, Calif., Nov. 16 /PRNewswire/ -- Exelixis, Inc. (Nasdaq: EXEL) today announced that its licensee Helsinn Healthcare SA has discontinued enrollment of new patients in the becatecarin (XL119) Phase III clinical trial program in biliary tract tumors. Exelixis in-licensed becatecarin from Bristol-Myers Squibb in 2001 and subsequently out-licensed it to Helsinn in June 2005. Helsinn reported that despite some evidence of becatecarin activity, preliminary analysis of the Phase III data by an Independent Data Monitoring Committee indicated that the comparator agent 5-fluorouracil (5-FU) demonstrated a greater than expected survival benefit, making it statistically improbable that the final study results could achieve the planned objectives for the trial.

About Becatecarin

Becatecarin is a small molecule, anticancer compound for the treatment of hepatobiliary duct tumors, a rare and aggressive form of cancer with a high medical need and very limited survival. Becatecarin was granted orphan drug designation in the United States and the European Union.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in Phase II and Phase I clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Sankyo. For more information, please visit the company's web site at www.exelixis.com.

Exelixis shares sink after Helsinn halts study

Thu, 16 Nov 2006 19:01:37 -0500

Shares of Exelixis took a hit after the biotech reported that Helsinn Healthcare had shelved a late-stage trial for the anti-cancer therapy becatecarin (XL119). Helsinn had licensed the therapy from Exelixis, which in turn, had licensed it from Bristol-Myers Squibb. Helsinn halted enrollment after concluding that the therapy was proving less effective than chemotherapy. The drug was aimed at tumors of the biliary tract.

- here's the AP report on the trial

Regeneron wins rich pact for VEGF trap

Wed, 18 Oct 2006 20:01:38 -0400

Bayer has agreed to pay Regeneron $75 million up front and up to $245 million more in milestone payments in a licensing pact for an experimental VEGF trap therapy for eye diseases. A VEGF trap belongs to the category of drugs known as angiogenesis inhibitors. This therapy blocks the action of vascular endothelial growth factor and prevents the growth of new blood vessels into a tumor. Researchers will develop the therapy for wet age-related macular degeneration and other conditions. The pact includes a profit-sharing arrangement for all countries outside the U.S. Regeneron retains full U.S. commercialization rights.

- read the AFX report for more information