Tag Archive | "prostate"

New cancer drug ’shows promise’

Tags: , , , , , , , , , , , ,


Researchers say a new type of cancer treatment has produced highly promising results in preliminary drug trials.

Olaparib was given to 19 patients with inherited forms of advanced breast, ovarian and prostate cancers caused by mutations of the BRCA1 and BRCA2 genes.

In 12 of the patients – none of whom had responded to other therapies – tumours shrank or stabilised.

The study, led by the Institute of Cancer Research, features in the New England Journal of Medicine.

One of the first patients to be given the treatment is still in remission after two years.

[ad]

Olaparib – a member of a new class of drug called PARP inhibitors – targets cancer cells, but leaves healthy cells relatively unscathed.

The researchers, working with the pharmaceutical company AstraZeneca, found that patients experienced very few side-effects, and some reported the treatment was “much easier than chemotherapy”.

Researcher Dr Johann de Bono said the drug should now be tested in larger trials.

He said: “This drug showed very impressive results in shrinking patients’ tumours.

“It’s giving patients who have already tried many conventional treatments long periods of remission, free from the symptoms of cancer or major side-effects.”

Olaparib is the first successful example of a new type of personalised medicine using a technique called “synthetic lethality” – a subtle way of exploiting the body’s own molecular weaknesses for positive effect.

In this case the drug takes advantage of the fact that while normal cells have several different ways of repairing damage to their DNA, one of these pathways is disabled by the BRCA mutations in tumour cells.

Olaparib blocks one of the repair pathways by shutting down a key enzyme called PARP.

This does not affect normal cells because they can call on an alternative repair mechanism, controlled by their healthy BRCA genes.

But in tumours cells, where the BRCA pathway is disabled by genetic mutation, there is no alternative repair mechanism, and the cells die.

Cancer cells with the BRCA1 or BRCA2 mutations are the first to be shown to be sensitive to PARP inhibitors.

But there is evidence that olaparib will also be effective in other cancers with different defects in the repair of DNA.

Professor Stan Kaye, who also worked on the study, said: “The next step is to test this drug on other more common types of ovarian and breast cancers where we hope it will be just as effective.”

[ad]

The researchers say the process of drug evaluation and registration may have to be revamped to take consideration of the fact that new generation cancer drugs target specific molecular defects, rather than types of cancer.

Dr Peter Sneddon, of the charity Cancer Research UK, said: “It is very encouraging to see the development of ‘personalised treatment’, tailored to the requirements of the individual patient, becoming a reality as it offers the opportunity to design new drugs that are truly selective.

“Although development of this drug is in its early stages, it is very exciting to see that it has the potential to work when other treatment options have failed.”

Source: BBC NEWS

Popularity: 3% [?]

Report shows 15-year decline in US cancer death rates

Tags: , , , , , ,


Data from the American Cancer Society’s annual cancer statistics report showed that from 1990 to 2005, death rates from cancer in the US dropped by 19.2 percent in men and 11.4 percent in women. The ACS attributed the changes to improved treatments as well as better prevention and detection practices.

[ad]

Figures showed that 80 percent of the decline for men was due to fewer deaths from colorectal, lung and prostate cancers, while 60 percent of the drop for women was due to fewer deaths from colorectal and breast cancers. The analysis also indicated that lung cancer was responsible for the highest number of fatalities, followed by colon cancer. John Seffrin, chief executive of the ACS, said a 1-percent or 2-percent yearly decline in the cancer death rate has translated into as many as 650 000 lives being spared over the 15-year period.

According to other statistics gathered by the ACS, overall cancer rates in men fell 1.8 percent per year from 2001 to 2005, and declined 0.6 percent per year in women from 1998 to 2005. In addition, the report noted that the five-year relative survival rate for all cancers diagnosed between 1996 and 2004 was 66 percent, compared to 50 percent between 1975 and 1977.

Source: FirstWord

Popularity: 2% [?]

Amgen’s submission for denosumab accepted in US

Tags: , , , , ,


Amgen announced that the FDA accepted the company’s filing for denosumab for the treatment and prevention of postmenopausal osteoporosis, and for the treatment and prevention of bone loss in patients with either prostate or breast cancer who are undergoing hormone therapy.

[ad]

Amgen said it has also made submissions to market the RANK Ligand inhibitor in the EU, Switzerland, Canada and Australia.

Source: FirstWord

Popularity: 3% [?]

Anavex Scales Up Synthesis Of Anavex 2-73 For Phase 1 Alzheimer’s Disease Study

Tags: , , , , , , , , , , , , , , , , , ,


ATHENS, GREECE – Anavex Life Sciences Corp., (“ANAVEX”) (OTCBB: AVXL) has signed an agreement with organic chemistry services provider Syntagon AB (“Syntagon”) for the scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease.  ANAVEX 2-73 is scheduled to commence Phase 1 studies in 2009.

[ad]

“The agreement with Syntagon is another important and tangible step towards the further development of ANAVEX 2-73 and commencement of Phase 1 clinical trials,” said Harvey Lalach, President of ANAVEX.  “We are very pleased with our progress to date with the compound, which shows enormous potential to modify and reverse the effects of Alzheimer’s disease.  We look forward to continued success as we move into our scheduled Phase 1 trials.”

ANAVEX plans to engage a Contract Research Organization (CRO) shortly to carry out the Phase 1 clinical trials.

During pre-clinical studies (in vitro and in vivo in mice), ANAVEX 2-73 demonstrated powerful neuroprotective, anti-amnesic, anti-apoptotic, anti-oxidative and anti-convulsive properties.  It also exhibited an excellent safety profile and therapeutic activity at very low doses.  The compound is a novel tetrahydrofuran that exhibits high affinity and selectivity to sigma-1 receptors and synergistic action with muscarinic receptors.  Additional beneficial effects have been demonstrated on NMDA receptors.

Syntagon is a provider of synthetic organic chemistry services headquartered in Sodertalje, Sweden.  The company has produced candidate drugs for use in clinical trials for a number of major pharmaceutical clients. Syntagon works in accordance with current industry quality standards, and is inspected and approved by the relevant regulatory authorities with respect to the development and manufacturing of material for use in clinical trials.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.

ANAVEX’s SIGMACEPTOR™-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compounds have performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of the company’s new alternative approach to the disease.

ANAVEX SIGMACEPTOR™-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Source: ANAVEX Life Sciences Corp.

Popularity: 6% [?]

Anavex presents potent neuroprotective effects of Anavex 1-41 at Neuroscience 2008

Tags: , , , , , , , , , , , , , , , , , , , ,


Anavex Life Sciences Corp. (“ANAVEX”) (OTCBB), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, was selected to present its latest results with ANAVEX 1-41 at Neuroscience 2008, the 38th annual meeting of the Society for Neuroscience, which took place November 15-19, 2008 in Washington, DC.

In a scientific poster abstract, ANAVEX detailed the outstanding neuroprotective potential of ANAVEX 1-41, evidenced by its ability to block the manifestation of the earliest toxic effects in a validated mouse model of Alzheimer’s disease. Currently in the late pre-clinical stage, ANAVEX 1-41 has shown synergistic potential for anti-amnesic and neuroprotective efficacy at extremely low doses. This is the first time these results have been attained by any pharmacological agent in an Alzheimer’s mouse model involving the injection of the amyloid-beta (25-35) peptide.

“We are excited by our ongoing progress in the development of ANAVEX 1-41 as it continues to demonstrate powerful neuroprotective action at extremely low doses with no toxicity,” said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. “In addition, we believe that our latest findings have relevance for ANAVEX 2-73, another lead Alzheimer’s compound, as 1-41 and 2-73 have a common origin and similarities in mechanism of action.”

[ad]

The earliest toxic effects of Alzheimer’s disease mouse models were measured by the expression of the caspase-12 marker. Caspase 12 is a recently discovered enzyme that indicates these early toxic effects. Non-transgenic Alzheimer’s mouse models are created by injecting amyloid-beta peptide (amyloid-beta 25-35) into mouse brains to bring on histological and biochemical changes, oxidative stress and learning deficits.

The neuroprotective potential of ANAVEX 1-41 is hypothesized to act by the compound’s ability to modulate sigma receptors which regulate calcium mobilization in neuronal cells. Calcium is regulated through the Inositol Triphosphate receptors “IP3R” and the sarcoendoplasmic reticulum “Ca2+/ATPase” pump.

The major effect of ANAVEX 1-41 occurs at the membrane of neuronal cells, in the endoplasmic reticulum (ER). The novel profile of ANAVEX 1-41, which is a mixed sigma-1, muscarinic and sodium-channel candidate drug, accounts for its ability to fight ER stress and thereby prevent apoptosis of the neuronal cells. This neuronal apoptosis is the prominent pathophysiological effect of brain degeneration in Alzheimer’s disease.

The neuroprotective effects of ANAVEX 1-41 were assessed in the hippocampus, the area of the brain that regulates learning, emotion and memory and which is highly implicated in Alzheimer’s disease. As recently discovered in pre-clinical testing, through its sigma-1 activity, ANAVEX 1-41 targets neuron structures (ER, mitochondria), as well as disturbed biochemical pathways and channels (UPR,IP3R,Bcl-2,apoptosis). Organizations involved in sigma receptor research, including ANAVEX, have determined that these are crucial factors in Alzheimer’s disease and in many other neurodegenerative diseases.

The company expects to complete pre-clinical trials on ANAVEX 1-41 in early 2009.

ANAVEX 1-41 and ANAVEX 2-73 share a common origin and related profile (congeners). ANAVEX is currently planning to prepare the Investigational New Drug (IND) (or IMPD) file to advance 2-73 to Phase 1 human clinical trials, which are expected to begin in 2009.

A copy of the poster abstract, titled “The neuroprotective action of ligands acting at the sigma-1 chaperone protein involves regulation of the expression of IP3 receptor subtypes and SerCa pumps,” can be viewed on the company’s web site at http://www.anavex.com/sfn08.html. The authors are Vanessa Villard, Fanny Malhaire-Ferreux, Francois Monnet, Alexandre Vamvakides and Tangui Maurice.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.

ANAVEX’s SIGMACEPTOR(TM)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compounds have performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of the company’s new alternative approach to the disease.

ANAVEX SIGMACEPTOR(TM)-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

Source: Anavex Life Sciences Corp.

Popularity: 5% [?]

Some breast cancers may clear up without treatment: study

Tags: , , , , , , , , , , , , , , , , , ,


A significant portion of invasive breast cancers may regress on their own without treatment, a new study that is bound to provoke controversy suggests.

The study, published Monday in the journal Archives of Internal Medicine, suggests breast cancer screening may be leading to over diagnosis of cancer, with upwards of 22 per cent of cases likely to resolve themselves without treatment.

Once a breast cancer is found, it wouldn’t currently be considered ethical not to treat. So — if the theory is correct — large numbers of women may be having surgeries, radiation, chemotherapy and other treatments that would never have been needed if their cancers hadn’t been detected.

[ad]

“If we are right, then this is a kind of paradigm shift,” said lead author Dr. Per-Henrik Zahl, a senior statistician with the Norwegian Institute of Public Health.

Zahl, who admitted he has been trying to get the study published for about four years, said the risks of over diagnosis of breast cancer are real.

Radiation can do significant and permanent damage to the heart and coronary arteries. Chemotherapy can cause cognitive confusion. And surgery that involves the removal of lymph nodes can cause lymphedema, the painful swelling of the arm closest to the involved breast.

Dr. Patrick Remington has been studying the idea of self-limiting breast cancers since the early 1990s, when the introduction of breast screening programs showed a sharp and sustained increase in the incidence of the disease in the United States. He is convinced some invasive breast cancers do regress; they have become known as LMPs or cancers of “limited malignant potential.”

“I would say a very good guess would be about one out of three women have cancers detected today that would not have progressed otherwise,” said Remington, a professor of population health sciences at the University of Wisconsin. Remington was not involved in this study.

He notes some other types of cancers — prostate and recently lung — have been shown to spontaneously regress in some patients.

In the case of prostate cancer, some physicians urge an approach known as watchful waiting, where patients are monitored to see if their disease is progressing; only then is it treated. That approach is not currently an option with breast cancer.

Several journals refused to publish study

Zahl’s findings are likely to spark heated debate. In fact, he acknowledged several journals refused to publish the study before it was accepted by Archives of Internal Medicine, a journal published by the American Medical Association.

An editorial in the journal stressed that the findings are consistent with several observations about breast cancer that have troubled investigators for years.

And the editorial’s authors, Dr. Robert Kaplan of the UCLA School of Public Health and Dr. Franz Porzsolt of Germany’s Clinical Economics University of Ulm, said the hypothesis of breast cancer regression, while counterintuitive, is “difficult to rule out.”

“We know from autopsy studies that a significant number of women die [from other causes] without knowing that they had breast cancer,” they noted.

Dr. Steven Narod, a leading breast cancer researcher at Toronto’s Sunnybrook Health Sciences Centre, agreed the findings are persuasive.

Some breast cancers disappear on their own

“I do agree with them that the best explanation of the findings is that about 10 to 20 per cent of the breast cancers … disappeared on their own,” he said.

“I’m still a bit skeptical and there’s alternative explanations, but I think this one is worth paying attention to.”

In what Narod described as an “elegant” study design, Zahl and his colleagues used the introduction of a breast cancer screening program in Norway to explore the question.

They compared breast cancer rates among nearly 120,000 women who had three rounds of mammography between 1996 and 2001 to those among nearly 110,000 women of the same age range (50 to 64) in the five-year period preceding the start of the breast cancer screening program. Those women, known as the controls, had one mammogram.

In statistical terms, the two groups of women were identical. Their educational profile was closely matched, they had roughly the same average family income and the same average number of children. So the rates of cancers in the two groups should have been equal.

In fact, the women who hadn’t been regularly screened had 22 per cent fewer breast cancers.

The authors explore a number of arguments about why that might be. They noted for instance that use of hormone replacement therapy in the part of Norway where the women lived increased substantially between 1996 and 2001, the period when the screened women were undergoing regular mammograms. HRT use is linked to increased risk of breast cancer.

Looking for an explanation

But the authors conclude none of the potential other explanations could account for such a large difference between the two groups.

“All the caveats that could be explored have been explored in terms of accounting for the things that people would call … weaknesses” of the study, agreed Dr. Cornelia Baines, a professor in the University of Toronto’s school of public health and co-principal investigator of a landmark study into mammography, the Canadian National Breast Screening Study.

Baines, who has been diagnosed with breast cancer that was earlier missed in a mammogram, said the findings are important.

But she added that even if Zahl and his co-authors are correct, there’s no way currently to put the findings into application.

“The incontrovertible truth is that once you’ve screened a woman and you find an abnormality, you have to biopsy,” she said.

“If you biopsy, you have to follow through with surgery if the biopsy reveals malignant tissue. You can’t stop that. You can’t say: ‘Well, I’ve been screened and there is a chance that this is over diagnosis.’ You can’t do that.”

No scientific reason for why cancers regress

Finding ways to answer the questions raised by the study will be difficult, experts said. Remington noted even if doctors could differentiate, women and-or their health-care professionals might still opt for treatment to play it safe.

He suggested, though, studying women whose cancers regress on their own could teach scientists how to trigger the same response in women whose cancers aren’t self-limiting, and maybe even to prevent breast cancer from developing.

In the meantime, Baines said, this study may serve as an important reminder to women and the medical community.

“What is important and it seems to me it’s been ignored for a long, long time is that …screening doesn’t only have upsides. It has downsides,” she said.

“And if women want to accept the downsides and proceed with screening, then that’s great. But I personally believe that they should only make that choice when they are fully informed. And a lot of them have not been fully informed about the over diagnosis scenario.”

Source: cbcnews.ca

Popularity: 4% [?]

Oxford BioMedica’s cancer vaccine TroVax

Tags: , , , , , , ,


Oxford BioMedica reported that data from a cross-trial analysis of investigational therapeutic vaccine TroVax suggest that there is a positive correlation between immune response to the 5T4 tumour antigen, targeted by the vaccine, and increased survival in patients with colorectal, renal and prostate cancer. TroVax is being developed in partnership with sanofi-aventis.

[ad#post]

The analysis was based on data from nine Phase I and Phase II studies involving a total of 189 evaluable patients. The results showed that 88 percent of those who received the injection produced antibodies for the 5T4 antigen, and that there was a statistically significant association between the immune responses and overall survival. Specifically, a doubling of antibody response was associated with a reduction of 16 percent in the relative risk of death, with the effect being strongest in patients with colorectal cancer, who exhibited a 19-percent reduction in relative risk of death.

Richard Harrop, vice president of clinical immunology at Oxford BioMedica, commented that “while it is essential that these observations are confirmed in large, randomised studies, collectively the data suggest that TroVax could provide some clinical benefit to cancer patients.” He also noted that “the data show the vaccine is well tolerated by patients.”

The vaccine is currently undergoing Phase III trials in renal cancer, and Oxford BioMedica said that it plans to conduct two late-stage studies of the compound in patients with colorectal cancer.

Source: FirstWord

Popularity: 2% [?]

Scientists develop new cancer-killing compound

Tags: , , , , , ,


Researchers at University of Washington have updated a traditional Chinese medicine to create a compound that is more than 1,200 times more specific in killing certain kinds of cancer cells than currently available drugs, heralding the possibility of a more effective chemotherapy drug with minimal side effects.

The new compound puts a novel twist on the common anti-malarial drug artemisinin, which is derived from the sweet wormwood plant. Sweet wormwood has been used in herbal Chinese medicine for at least 2,000 years, and is eaten in salads in some Asian countries.

[ad#post]

The scientists attached a chemical homing device to artemisinin that targets the drug selectively to cancer cells, sparing healthy cells. The compound kills 12,000 cancer cells for every healthy cell, meaning it could be turned into a drug with minimal side effects. The results were published in the latest issue of journal Cancer Letters.

“The compound is like a special agent planting a bomb inside the cell,” said Tomikazu Sasaki, chemistry professor at UW and senior author of the study.

A cancer drug with low side effects would be more effective than currently available drugs, since it could be safely taken in higher amounts, he said.

In the study, the UW researchers tested their artemisinin-based compound on human leukemia cells. It was highly selective at killing the cancer cells.

The researchers also have preliminary results showing that the compound is similarly selective and effective for human breast and prostate cancer cells, and that it effectively and safely kills breast cancer in rats, Sasaki said.

Source: Xinhua

Popularity: 2% [?]

Cell Genesys Announces Termination of VITAL-1 Phase 3

Tags: , , , , , , , , ,


Cell Genesys, Inc. (Nasdaq:CEGE) today announced its decision to terminate the VITAL-1 Phase 3 clinical trial of GVAX immunotherapy in patients with asymptomatic metastatic hormone-refractory prostate cancer. The trial was fully enrolled in 2007 with 626 patients and compared GVAX immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone. The Company terminated the trial based on the results of a previously unplanned futility analysis conducted by the study’s Independent Data Monitoring Committee (IDMC) which indicated that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in survival. Read the full story

Popularity: 3% [?]

Poniard Announces Positive Incremental Efficacy and Safety Data

Tags: , , , , , , , , , , ,


Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced positive incremental data from its ongoing Phase 2 clinical trial of picoplatin in combination with docetaxel and prednisone as first-line therapy for metastatic hormone-refractory prostate cancer (HRPC). The expanded and updated results continued to show that picoplatin can be safely administered with full-dose docetaxel and prednisone, the standard treatment for HRPC, with no neurotoxicity observed. In addition, reductions of prostate specific antigen levels (PSA) of at least 50 percent were achieved in 78 percent of evaluable patients. Normalized PSA levels were achieved in 26 percent of patients.

“These data are very encouraging as they suggest that picoplatin can be safely administered with full doses of docetaxel as first-line therapy in the treatment of hormone-refractory prostate cancer,” said E. David Crawford, M.D., professor of surgery and radiation oncology, and head of the Section of Urologic Oncology at the University of Colorado Denver and associate director of the University of Colorado Comprehensive Cancer Center in Denver. Dr. Crawford also is a member of Poniard’s Clinical Advisory Board. “I believe these early Phase 2 results may potentially support a Phase 3 trial. A therapy with an improved safety and efficacy profile would be important for patients with advanced prostate cancer, who have a very poor prognosis and few effective treatment options.”

The data were presented in a poster session (abstract # 211/poster #211) during the 20th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer” in Geneva, Switzerland. Picoplatin, the Company’s lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations for the treatment of multiple solid tumor indications.

Phase 2 HRPC Trial Design and Preliminary Results

In the ongoing Phase 2 trial, the efficacy and safety of intravenous picoplatin (120 mg/m squared) administered every three weeks (21 days) in combination with full-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a first-line treatment are being evaluated in 30 patients with metastatic HRPC who have not received prior chemotherapy. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.

Results presented at the Symposium showed a PSA response of at least 50 percent in 78 percent of the 27 evaluable patients and also showed that the combination of picoplatin and full-dose docetaxel can be safely administered. Manageable and reversible neutropenia were the main hematologic toxicities. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent in combination with docetaxel. To date, no neurotoxicity has been observed in this study. These findings confirm and extend earlier Phase 2 results presented at the 44th Annual Meeting of the American Society of Clinical Oncology in May and results from the Phase 1 trial presented earlier this year.

“We are encouraged by the PSA decreases observed with picoplatin in combination with docetaxel to date and with the finding that picoplatin continues to be well tolerated in this Phase 2 proof-of-concept trial,” said Robert De Jager, M.D., chief medical officer of Poniard. “Additional data from this ongoing study may support the advancement of picoplatin into a Phase 3 clinical trial for HRPC. Our growing body of safety and efficacy data also supports the potential for additional uses of picoplatin as a combination therapy in the treatment of non-small cell lung and ovarian cancers where platinum and taxane combinations are currently used.”

About Picoplatin

Picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It is being studied in multiple cancer indications, combinations and formulations. Picoplatin has been evaluated in more than 750 patients and has demonstrated anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs.

In addition to the ongoing Phase 2 clinical trial in HRPC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registration trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. Picoplatin is also being evaluated in a Phase 2 clinical trial in patients with metastatic colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. The oral formulation of picoplatin has the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by any regulatory authority for use in humans.

About Poniard Pharmaceuticals

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. For additional information please visit http://www.poniard.com.

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, timing and results of clinical trials and the potential safety and efficacy of its products in development. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007 and its Quarterly Report on Form 10-Q for the period ended June 30, 2008. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

SOURCE Poniard Pharmaceuticals, Inc.

Popularity: 3% [?]

Site Sponsors