ZIOPHARM inititiates ZIO-101 study

ZIOPHARM Oncology, Inc. (OTC BB: ZIOP), announced today that ZIO-101, a novel and proprietary form of organic arsenic, has been administered to the first patient in a phase I/II trial in advanced myeloma. Interim data from an ongoing phase I trial suggest ZIO-101 can be given at significantly higher doses, with no significant toxicity, compared to arsenic trioxide, an inorganic arsenic currently approved to treat APL. Arsenic trioxide has also shown activity in myeloma. The ongoing phase I study is currently in cohort five with dosing about 45 times higher than the approved dose of arsenic trioxide.

"Phase I study results to date are encouraging with signals of drug activity and safety," said Bart Barlogie, M.D., Ph.D., Director, Myeloma Institute for Research Therapy, University of Arkansas for Medical Sciences. "We look forward to participating in the next phase of development in patients with advanced myeloma where treatment alternatives remain an unmet medical need."

"I am optimistic about ZIO-101 as a potential new treatment option for our myeloma patients since much higher doses of this new arsenical can be safely administered compared to other older arsenic-based agent," commented James Berenson M.D. of Berenson Oncology. "Given that these other arsenic agents have shown anti-myeloma effects clinically at much lower doses, the hope is that this new drug with its much higher dose will show greater benefits for patients with this disease."

"Patients with myeloma often experience significant treatment side effects and eventually become drug resistant at therapeutic doses," said Mohamad Hussein M.D., Director, Cleveland Clinic Myeloma Research Program. "Arsenical compounds when given at therapeutic doses may have several mechanisms of action and may also modulate the immune system and control the disease. With this trial we hope to identify the doses associated with ZIO-101 that are most therapeutic for patients with multiple myeloma."

Investigators and centers expected to participate in this study include:
- Bart Barlogie, M.D., Ph.D., University of Arkansas for Medical Sciences
- Andrew Belch, M.D., Cross Cancer Institute, Canada
- James Berenson M.D., Berenson Oncology, Los Angeles
- Mohamad Hussein M.D., Cleveland Clinic Myeloma Research Program
- Sundar Jagannath, M.D., St. Vincent's Comprehensive Cancer Center, New York
- Kelvin Lee, M.D., University of Miami Miller School of Medicine
- Amin Rahemtulla, M.D., Ph.D., Imperial Myeloma Group and Hammersmith Hospital, U.K.
- Donna Reece, B.A., M.D., FRCPC, Princess Margaret Hospital, Canada

About ZIOPHARM Oncology, Inc.

ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights of molecular and cancer biology to the understandings of efficacious, but highly toxic cancer therapies and identifies proprietary and related drugs to provide more effective and safer cancer therapy for patients. For more information, visit www.ziopharm.com.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and the Company's reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Source: www.ziopharm.com

MMRC ancillary tissue collection project

Multiple Myeloma Research Consortium (MMRC) Ancillary Tissue Collection Project

Purpose

The MMRC Tissue Bank is collecting blood and bone marrow samples and correlating clinical data from patients with multiple myeloma at the time of their blood or marrow donations for clinical care. The collection of these samples will be critical to support ongoing research projects in the area of tumor genomics and in general for tumor biology. These samples will be collected, processed and stored in a way that will allow their future use in multiple research projects and may be shared in the future with outside investigators (researchers outside of the Consortium). The samples will be housed at the MMRC Tissue Bank currently located at Mayo Clinic Scottsdale, Arizona and will be stored indefinitely.

Regimen

Patients diagnosed with multiple myeloma with any stage of disease regardless of the number or type(s) of prior treatments may participate in this tissue collection study. Samples will be collected at the clinic only after informed consent has been voluntarily given by the study participant. At the time of routine clinical procurement the physician will collect up to 40 cc of extra bone marrow aspirate and up to 50 cc of peripheral blood. The study participant’s medical record will be reviewed prior to blood draw and participants with hemoglobin that is less than 7g/dl will be excluded from this collection. Study participants may donate a sample to the MMRC Tissue Bank with each clinically necessary bone marrow aspirate procurement.

Study participants will be assigned a unique identification number so that only the physician and his/her staff at the enrolling institution will be able to link the unique identification number to the participant’s identifiable information.

Once the study participant donates a sample to the MMRC Tissue Bank, the physician or his/her staff at the clinic will code the sample with a unique sample number so as not to identify the study participant. This number is different than the number the participant is assigned as explained above. This number is also different for each time a participant donates a sample. This code will allow the sample to be used without anyone knowing that it is the participant’s sample just by looking at the label. Only the physician or his/her staff at the clinic will be able to link the sample’s unique identification number to the participant’s name.

These identifiers will allow for the retrospective linking of a sample to the medical record such that we can perform the appropriate clinical correlations and annotations. The list with these links will be kept in a locked secured place at the clinic and all transfer of information will be done consistent with current HIPAA guidelines for participants’ privacy and protection.

Arizona
Scottsdale, AZ
Mayo Clinic - Scottsdale

Florida
Tampa, FL
H. Lee Moffitt Cancer Center & Research Institute

Minnesota
Rochester, MN
Mayo Clinic - Rochester

Massachusetts
Boston, MA
Dana-Farber Cancer Institute

Canada
Toronto, ON
Princess Margaret Hospital

Source: http://multiplemyeloma.org/clinical_trials/ctm/4.04.209.html

Genomics to identify high-risk myeloma after auto

Although high-dose therapy/autologous stem cell transplantation has become the standard of care for patients with multiple myeloma, survival is highly variable and can range from a few years to >10 years after diagnosis. Application of high-throughput genomics on a large uniformly untreated cohort of patients has revealed that activation of 1 of the 3 cyclin D genes is a universal initiating event in this disease and that acquisition of abnormalities of chromosome 1 leads to activation of CKS1B, a regulator of p27Kip1 degradation. Synergy between cyclin D2 and CKS1B, but not cyclin D1 and CKS1B, may lead to early treatment failure.

Shaughnessy JD Jr, Barlogie B.

Donna D. and Donald M. Lambert Laboratory of Myeloma Genetics, Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, Arkansas.

PMID: 16399589 [PubMed - in process]

Baxter Immune Globulin update

Baxter Receives Marketing Authorization from the European Commission for KIOVIG to Treat Immunodeficiencies

Baxter Healthcare S.A. announced today that the European Medicines Agency (EMEA) has issued a Marketing Authorization for KIOVIG™ [Immune Globulin Intravenous (Human)], Baxter´s ready-to-use liquid 10% Intravenous Immunoglobulin (IVIG).

KIOVIG is indicated in the European Union for replacement therapy in Primary Immunodeficiency Disorders (PID), Myeloma or Chronic Lymphocytic Leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections, children with congenital AIDS and recurrent infections, Kawasaki Syndrome, allogeneic bone marrow transplantation, Guillain Barré Syndrome, and Idiopathic Thrombocytopenic Purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

The product offers fast and effective treatment and enhanced convenience. Its efficacy and tolerability have been demonstrated in multi-center clinical trials in Europe and the United States. The manufacturing process also incorporates three dedicated viral reduction steps. The ready-to-use preparation eliminates the need for reconstitution and its 10% concentration allows for reduced infusion volume when compared to 5% concentrations. In addition, it is the first and only 10% IVIG solution with the following combination of features: no added sugars, no added sodium, no added preservatives, latex-free packaging and an option to store the product at room temperature for up to nine months.

“The launch of KIOVIG is the latest step in Baxter's efforts toward advancing the science of IVIG," said Jim Utts, president of Baxter Europe. “We are excited to offer this new liquid IVIG to help meet the needs of physicians, healthcare professionals and patients.”

KIOVIG received a unanimous positive opinion recommendation from the Committee for Medicinal Products for Human Use (CHMP) in November of 2005, which served as the basis for approval by the European Commission. Approval from the European Commission will allow Baxter to market the therapy in all 25 European Union member states, as well as Norway and Iceland.

Baxter received regulatory approval from the U.S. FDA in May of 2005, and the therapy was launched in the United States in September. A submission for approval was also made to Health Canada in December of 2004.

About KIOVIG

The product is a ready-to-use, sterile 10% preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. It is processed from human plasma and contains a broad spectrum of IgG antibodies against infectious agents. Assuring state of the art quality standards for the manufacture begins with the donor selection process and continues throughout plasma collection, which only occurs at licensed plasma collection facilities. To further support the margin of safety, three validated, independent and effective virus inactivation/removal steps have been integrated into processing and formulation (solvent/detergent (S/D) treatment, nanometer filtration and low pH incubation at elevated temperature).

About Primary Immunodeficiency Disorders

Primary Immunodeficiency Disorders (PID) encompass more than 100 diseases caused by an immune system that does not function correctly. In Europe, PID affects approximately one in 500 people, and experts estimate that another one in 500 is yet undiagnosed. For the EU, this is equivalent to 1.5 million affected individuals, 50 percent of whom are undiagnosed. IVIG therapy can restore IgG levels to normal or near normal, helping the immune system function properly and prevent infections or combat them when they occur.

About Autoimmune Disorders

Autoimmune disorders encompass a broad spectrum of human illnesses. Autoimmune diseases are defined as diseases in which the progression from benign autoimmunity to pathogenic autoimmunity occurs. In such cases the immune system mistakenly identifies a person's own tissues (e.g. nerve cells) as foreign and attacks and destroys them. IVIG therapy can help neutralize auto-antibodies and also help modulate B-cell response, which may lead to stabilization of the patient.

Important Safety Information for the United States

KIOVIG is marketed as GAMMAGARD LIQUID™ [Immune Globulin Intravenous (Human)], in the United States.

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA <>

IVIG products have been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIG products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. GAMMAGARD LIQUID does not contain sucrose.

GAMMAGARD LIQUID is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.

The potential risks and benefits of IVIG should be weighed against those of alternative therapies for all patients for whom IVIG administration is being considered.

Please visit www.gammagardliquid.com for full U.S. prescribing information.

Source: http://www.baxter.com

BiovaxID major advance against NHL

BiovaxID™ Yields 89 Percent Survival In Patients With Aggressive Non-Hodgkins

Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) and its subsidiary, Biovest International, Inc. (OTCBB:BVTI), report follow-up data to a Phase 2 trial conducted by the National Cancer Institute (NCI) that shows Biovest's BiovaxID yielded an 89% survival rate in mantle cell lymphoma patients. The median follow-up was 3.8 years. Historically, patients with this type of lymphoma only have had a 50% chance of surviving 3 years and 20% chance of surviving 5 years. BiovaxID, an investigational personalized anti-cancer vaccine, stimulates the immune system to seek out and destroy tumor cells. The data were published in a recent edition of Nature Medicine (Nat Med.2005; 11(9):986-91).

In this single-arm, open-label Phase 2 clinical study, patients with untreated mantle cell non-Hodgkin's lymphoma (NHL) were administered six cycles of dose-adjusted EPOCH-R, a chemotherapy regimen that includes Rituxan® (rituximab). Of the 26 patients in the study, 23 received vaccinations with BiovaxID commencing at least three months after completing their last chemotherapy and Rituxan treatments. Upon the 46-month (3.8-year) follow-up, the overall survival rate was 89%. This study showed that, despite an almost complete depletion of normal B-cell lymphocytes due to EPOCH-R therapy, BiovaxID did induce anti-tumor T-cell lymphocyte responses in most patients. Depletion of normal B-cell lymphocytes is a consequence of the combination of chemotherapy and Rituxan, but not of BiovaxID therapy. Thus, "it is justifiable to administer vaccines in the setting of B-cell depletion, but vaccine boosts after B-cell recovery may be necessary for optimal humoral responses," concluded the investigators.

Lymphocytes are a type of white blood cell. There are two types of lymphocytes: B-cell lymphocytes, which produce antibodies ("humoral" immunity) in response to immune stimulation; and T-cell lymphocytes, which mediate cell responses to immune stimulation ("cellular" immunity). B-cell lymphocytes can undergo malignant transformation to become non-Hogkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.

"This is the first human cancer vaccine study to see T-cell responses in the absence of B-cells," said the study's first author, Sattva Neelapu, M.D., Assistant Professor in the Department of Lymphoma at the University of Texas M. D. Anderson Cancer Center. "This paves the way to use vaccines in a number of hematological cancers that are treated by eliminating diseased B-cells."

Biovest is now enrolling patients in a pivotal Phase 3 trial to test BiovaxID against follicular non-Hodgkin's lymphoma (NHL). Follicular NHL is an indolent (slow-growing) form of lymphoma not considered curable with existing therapies. The impressive findings from the Phase 2 clinical trial using BiovaxID in mantle cell lymphoma suggest the vaccine could potentially be used to treat other types of NHL, in addition to follicular NHL.

Background on immunotherapeutics for non-Hodgkin's lymphoma Rituxan is a passive immunotherapeutic consisting of a monoclonal antibody administered intravenously. The monoclonal antibody is directed to an antigen (CD20) present on most B-lymphocytes. Accordingly, Rituxan promotes the elimination of cancerous and normal B-lymphocytes bearing this antigen. Rituxan therapy is typically repeated as necessary at intervals in order to control the lymphoma. Annual sales for Rituxan are about $1.5B.

BiovaxID is an active immunotherapeutic that stimulates the production of anti-tumor antibodies and induces a cell-mediated immune response to cancerous B-lymphocytes but not to normal B-lymphocytes. As an active immunotherapeutic, BiovaxID may also provide ongoing immunosurveillance for recurrent tumors.

BiovaxID is a personalized therapeutic comprised of tumor-derived Id protein (tumor-specific antigen) conjugated (linked) to KLH (keyhole limpet hemocyanin) as a carrier protein administered with GM-CSF (granulocyte macrophage colony stimulating factor). GM-CSF is commercially available for other indications. BiovaxID is administered on an outpatient basis in the oncologist's office by means of a subcutaneous injection similar to an insulin shot.

BiovaxID is a premiere example of a targeted therapeutic. It stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without collateral damage to normal B-cell lymphocytes or to other cells.

BiovaxID is produced using a hybridoma cell-line developed by and licensed exclusively from Stanford University. BiovaxID contains high-fidelity copies of a tumor-specific antigen that is unique to each patient and that is found exclusively on the surface of each and every malignant B-lymphocyte but not found on the surface of normal B-lymphocytes or other cells. Competing technologies use recombinant techniques, which are copies of just a portion of the tumor-specific antigen. Biovest believes that a complete copy of the tumor specific antigen results in higher rates of immune responses in patients and more robust clinical outcomes, including molecular remissions.

Patients who believe they may be eligible to participate in a clinical trial with BiovaxID are encouraged to call 1-877 654-6052 or visit the web site at http://www.accentia.net.

About Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology. Two of these products are SinuNase and BiovaxID. The Company's SinuNaseTM product, in development to treat chronic sinusitis (rhinosinusitis), is a novel application and formulation of a known anti-fungal licensed from the Mayo Foundation for Medical Education and Research. BiovaxID is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID, which is being developed by Accentia's subsidiary Biovest International, Inc., is currently in a Phase 3 clinical trial. In addition, Accentia's growing specialty pharmaceutical business, TEAMM Pharmaceuticals, has a portfolio of currently marketed products plus a pipeline of additional products under development by third parties. For further information, please visit our web site: www.accentia.net.

About Biovest International

Biovest International, Inc. is a pioneer in the development of advanced individualized immunotherapies for life-threatening cancers of the blood system. Biovest is a majority owned subsidiary of Accentia Biopharmaceuticals, Inc. with its remaining shares publicly traded.

Biovest has a foundation in the manufacture of biologics for research and for clinical trials. In addition, Biovest develops, manufactures, and markets patented cell culture systems, including the AutovaxID, an instrument which is being developed for multiple commercial applications inclding automated vaccine manufacturing. Biovest's therapy for follicular non-Hodgkin's lymphoma is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative

Research and Development Agreement (CRADA) with the National Cancer Institute. For further information, please visit Biovest's website: http://www.biovest.com.

Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about BiovaxID and any other statements relating to products, product candidates, and product development programs. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia and/or Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward looking statements are qualified in their entirety by this cautionary statement, and neither Accentia nor Biovest undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof.

Kosan HSP90 update

KOSAN INITIATES PHASE I CLINICAL TRIAL OF ORAL HSP90 INHIBITOR KOS-1022

Hayward, CA – January 25, 2006 – Kosan Biosciences Incorporated today announced that it has initiated a Phase I multicenter trial of an oral formulation of KOS-1022 (DMAG), a second-generation heat shock protein 90 (Hsp90) inhibitor.

KOS-1022 is the first-reported Hsp90 inhibitor to be administered orally to patients with cancer. “Initiation of clinical testing of an oral formulation of KOS-1022 complements the development program for intravenous KOS-1022 and is an important step in our Hsp90 inhibitor program,” said Daniel V. Santi, M.D., Ph.D., Kosan Chairman and Chief Executive Officer. “In addition, given the convenience of oral dosing compared to intravenous dosing, the capsule formulation of KOS-1022 will allow us to investigate whether more continuous inhibition of Hsp90 will lead to enhanced antitumor activity.”

The Phase I clinical trial of oral KOS-1022 will evaluate the safety, pharmacokinetics, pharmacodynamics, and bioavailability of escalating doses of KOS-1022 in patients with advanced solid tumors, as well as assess any preliminary evidence of antitumor activity. The clinical trial will be conducted at the University of Colorado Health Science Center and the Presbyterian Hospital Medical Center at the University of Pennsylvania.

Intravenous KOS-1022 is currently being evaluated in a company-sponsored Phase I clinical trial in patients with hematologic malignancies as well as multiple Phase I clinical studies in patients with advanced solid tumors sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement between Kosan and the NCI Cancer Therapy Evaluation Program. Because of the complementary nature of oral and intravenous KOS-1022, Kosan plans to continue to develop both formulations.

In addition to oral and intravenous KOS-1022, Kosan’s first-generation Hsp90 inhibitor, a proprietary formulation of 17-AAG (KOS-953), is being investigated by Kosan in a Phase II clinical trial in combination with trastuzumab (Herceptin®) in patients with Her2 positive breast cancer, as well as clinical trials in patients with relapsed refractory multiple myeloma (both as single-agent and in combination with bortezomib (Velcade®)). Kosan may initially seek approval for KOS-953, in combination with Velcade, to treat relapsed refractory multiple myeloma. In 2004, Kosan obtained orphan drug designation for 17-AAG from both the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of multiple myeloma as well as another hematologic cancer, chronic myelogenous leukemia.

About Hsp90 Inhibitors

KOS-1022 and 17-AAG are analogs of the polyketide geldanamycin that inhibit Hsp90. KOS-953 is Kosan’s proprietary formulation of 17-AAG. Hsp90 is a molecular “chaperone” which maintains the stability of numerous “client proteins” implicated in tumor growth and metastasis, including protein kinases and transcription factors. By blocking the activity of Hsp90, geldanamycin analogs lead to disruption of the Hsp90-client protein complexes and client protein degradation. By targeting multiple growth-signaling pathways involved in cancer, these compounds may have potential use in a variety of tumor types, both as single agents and in combination with other signal transduction inhibitors and cytotoxic drugs.

About Kosan

Kosan Biosciences is advancing two new classes of anticancer agents through clinical development. Kosan is developing Hsp90 (heat shock protein 90) inhibitors in collaboration with the NCI. Kosan’s proprietary formulation of 17-AAG (KOS-953) is in Phase I and II clinical trials for multiple myeloma and Her2 breast cancer. In addition, intravenous and oral formulations of a second-generation Hsp90 inhibitor, KOS-1022 (DMAG), are currently in Phase I clinical trials. For additional information on Kosan Biosciences, please visit the Company's website at www.kosan.com.

This press release contains "forward-looking" statements, including statements with respect to the further development and potential safety and efficacy of Hsp90 inhibitors, including KOS-1022, in the treatment of cancer and Kosan’s development strategy for its Hsp90 inhibitors. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, the risk that the U.S. Food and Drug Administration may require changes to the protocols and informed consents for clinical trials of its Hsp90 inhibitors, which changes may have a material adverse effect on the timing of, and Kosan’s ability to conduct, those clinical trials, risks related to the clinical advancement of its Hsp90 inhibitors, including the risk that clinical trials for this product candidate may not demonstrate safety and efficacy sufficient to obtain the requisite regulatory approvals or to result in a marketable product, risks related to the potential for others to develop products containing or based on 17-AAG, risks related to Kosan’s dependence on the NCI for the development of its Hsp90 inhibitors and other risks detailed from time to time in the Company’s SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.

Herceptin® (trastuzumab) is a registered trademark of Genentech, Inc., and Velcade® (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.

Source: http://www.kosan.com

The dentist is your friend

Oral hygiene is of critical importance to the immuno-compromised patient to prevent oral infections. Prior to my transplant I was sent to a dentist to ascertain whether I had any potential cavities. Post transplant I've visited my dentist every six months and flossed and brushed daily.

Visit your dentist to gain advice on maintaining your oral hygiene.

Another oral health problem I faced was fungal infection. I used Nystatin even though I found it revolting. Later I was prescribed Dr. Akabutu's mouthwash which numbed my mouth, but at least I could tolerate it.

Skip the fish?

Eating fish and other foods high in omega-3 fatty acids doesn't have the wondrous effect on preventing malignancies that it seems to have in warding off heart disease.

As a cancer preventive strategy, omega-3 was left high and dry, reported Catherine H. MacLean, M.D., Ph.D., and colleagues at Rand Health in the January 25 issue of the Journal of the American Medical Association.

Source: http://www.medpagetoday.com/HematologyOncology/BreastCancer/tb/2545

MMRC partnership with MDS Pharma

MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has been selected as the preferred contract research organization (CRO) of the Multiple Myeloma Research Consortium (MMRC). MDS Pharma Services will manage multiple MMRC pre-clinical and clinical research efforts, including data management related to the MMRC's tissue collection program.

New drug BT-062

In a collaborative research effort AERES Biomedical, Ltd. and Biotest AG successfully completed the engineering of the monoclonal antibody BT-062.
The candidate is directed against a tumor-specific target expressed by multiple myeloma.

After BT-062 had shown impressive efficacy in an animal model of the disease, this is an important step towards the clinical development of the candidate.

Update on bortezomib

Bortezomib is the first proteasome inhibitor to be approved by the U.S. FDA and the European Agency for the Evaluation of Medicinal Products for the treatment of refractory or relapsed MM following the failure of at least two prior lines of therapy. Recently, it also received approval from the FDA for use as a second-line agent. An expert panel of hematologists met at the Ninth Congress of the European Hematology Association to review clinical data and experience in the treatment of MM with bortezomib, including bortezomib-based combination therapy. The conclusions of this expert panel, together with updated clinical data from the American Society of Hematology 46^th Annual Meeting, provide a practical update on the use of bortezomib in MM.

Bortezomib has demonstrated significant antitumor activity as a single agent in refractory and/or relapsed MM, with a significantly longer survival than with dexamethasone (1-year overall survival rate of 80% vs. 66%) and a 78% longer median time to progression. In combination therapy, patient responses suggest the possibility of chemosensitization and synergy. Furthermore, bortezomib does not appear to have an adverse effect on subsequent stem cell therapy. Bortezomib is well tolerated; most side effects are only mild to moderate and are manageable. Information is given on the practical management of the most common adverse events, including peripheral neuropathy and thrombocytopenia, and the use of bortezomib in renal and hepatic impairment.

San Miguel J, Blade J, Boccadoro M, Cavenagh J, Glasmacher A, Jagannath S, Lonial S, Orlowski RZ, Sonneveld P, Ludwig H.

Hematology Department, Hospital Clinico Universitario de Salamanca, Servicio de Hematologia, Paseo de San Vicente 58, Salamanca, Spain. sanmigiz@usal.es.

Relief from mouth sores during chemo

In terms of discomfort, the mouth sores after my chemo were really awful. It felt like I was swallowing razor blades to the point where I tried not to swallow at all. I was administered morphine for a few days to alleviate the pain. Anything that could address this common chemo complaint would be welcome.
***
Palifermin Reduces Patient-Reported Mouth and Throat Soreness and Improves Patient Functioning in the Hematopoietic Stem-Cell Transplantation Setting.

PURPOSE: To describe patient-reported outcomes of mouth and throat soreness (MTS) and related sequelae on daily activities from a phase III study of palifermin in the autologous hematopoietic stem-cell transplantation (HSCT) setting and to compare patient self-evaluations with clinicians' assessments of oral mucositis using objective scales.

METHODS: Patients (n = 212) received palifermin (60 microg/kg/d) or placebo for 3 days before total-body irradiation (12 Gy), etoposide 60 mg/kg, and cyclophosphamide 100 mg/kg, and 3 days after HSCT. Patients completed a daily questionnaire (Oral Mucositis Daily Questionnaire [OMDQ]) evaluating MTS severity and its effects on daily functional activities. Patients' self-assessment data were compared with clinicians' assessments of oral mucositis using the objective scales.

RESULTS: Palifermin reduced the incidence and duration of severe oral mucositis, as assessed by both clinicians and patients. Comparisons between patient and clinician assessments demonstrated that the average daily scores between mucositis grade and subjective (MTS) instruments were similar, although patients reported MTS onset, peak, and resolution earlier (1 to 3 days) than clinicians' assessments. Patients receiving palifermin reported statistically significant improvements (P < .001) in daily functioning activities (swallowing, drinking, eating, talking, sleeping) and required significantly less narcotic opioids (P < .001); improvement in the patient's overall physical and functional well-being was also reported. This was confirmed by the results of the Functional Assessment of Cancer Treatment questionnaire.

CONCLUSION: These results support the clinical benefit of palifermin in the HSCT setting, providing evidence that a patient's self-assessment instrument (OMDQ) may serve as an alternative tool to assess oral mucositis severity in clinical trials.

Stiff PJ, Emmanouilides C, Bensinger WI, Gentile T, Blazar B, Shea TC, Lu J, Isitt J, Cesano A, Spielberger R.

Yet another turmeric article

If you're not already adding turmeric to your diet, this article might convince you to start. I've included a few excerpts from the latest study.
***
Curcumin, a component of turmeric, has been shown to be non-toxic, to have antioxidant activity, and to inhibit such mediators of inflammation as NFκB, cyclooxygenase-2 (COX-2), lipooxygenase (LOX), and inducible nitric oxide synthase (iNOS). Significant preventive and/or curative effects have been observed in experimental animal models of a number of diseases, including arteriosclerosis, cancer, diabetes, respiratory, hepatic, pancreatic, intestinal and gastric diseases, neurodegenerative and eye diseases. Conclusions: Turmeric, an approved food additive, or its component curcumin, has shown surprisingly beneficial effects in experimental studies of acute and chronic diseases characterized by an exaggerated inflammatory reaction. There is ample evidence to support its clinical use, both as a prevention and a treatment. Several natural substances have greater antioxidant effects than conventional vitamins, including various polyphenols, flavonoids and curcumenoids. Natural substances are worth further exploration both experimentally and clinically. (Journal of Parenteral and Enteral Nutrition 30:45-51, 2006)

The cost of medication is a large and growing part of health expenditure. This is one of many reasons why inexpensive alternatives to standard pharmaceuticals for prevention and treatment of disease, methods which have been successfully practiced for centuries in countries such as India and China, are increasingly attractive. Agents with the documented ability to boost resistance and decrease vulnerability to disease, often referred to as chemopreventive agents, will have an important role to play. These substances are not only inexpensive, they are also easily available and have limited or no toxicity. Among these chemopreventive agents are a series of phenolic and other compounds believed to reduce aging and prevent degenerative malfunctions of organs: isothiocyanates in cruciferous vegetables, epigallocatechin-3- gallate (EGCG) in green tea, caffeic acid in coffee, capsaicin in hot chili peppers, chalcones in apples, euginol in cloves, gallic acid in rhubarb, hisperitin in citrus fruits, naringenin in citrus fruits, kaempferol in white cabbage, myricetin in berries, quercetin in apples and onions, resveratrol and other procyanidin dimers in red wine, and various curcumenoids found in turmeric curry.

Curcumin (CU): A Promising Tool

Interest in polyphenols, and especially in CU as a chemoproctive agent, has dramatically increased in recent years. CU, the most explored of the curcumenoids, has received increasing interest in recent years. The majority of studies reported thus far are experimental and few clinical studies have been published. This review is intended to provide a comprehensive description of the experimental and clinical effects of treatment with CU.

Cancer. Cancer is a group of > 100 different diseases, which manifest themselves in uncontrolled cellular reproduction, tissue invasion1, and distant metastases. Behind the development of these diseases is often exposure to carcinogens, which produce genetic damage and irreversible mutations if not repaired. During the last 50 years, attempts have been made to find or produce substances that could prevent these processes, so-called chemopreventive agents. Cancers are generally less frequent in the developing world, associated both with less exposure to environmental carcinogens and a richer supply of natural chemopreventive agents. The incidence per 100,000 population in the USA is considerably higher than in India for the following diseases: prostatic cancer (23 times), melanoma of the skin (male 14 times, female 9 times), colorectal cancer (male 11 times, female 10 times), endometrial cancer (9 times), lung cancer (male 7 times, female 17 times), bladder cancer (male 7 times, female 8 times), breast cancer (5 times), and renal cancer (male 9 times, female 12 times). These differences are even greater when compared with China for some diseases, such as breast cancer and prostatic cancer. Consumption of saturated fat and sugary foods is much less common in the Asian countries, but equally important, consumption of plants with high content of chemopreventive substances is significantly higher in these countries. As an example, the consumption of CU has for centuries been about 100 mg/ d in these Asian countries. CU induces in vitro apoptosis of various tumor cell lines: breast cancer cells, lung cancer cells, human melanoma cells, human myeloma cells, human leukemia cell lines, human neuroblastoma cells, oral cancer cells, and prostatic cancer cells. CU also inhibits intrahepatic metastases in experimental models.

Source: American Society for Parenteral and Enteral Nutrition
http://jpen.aspenjournals.org/

See also:
http://myelomic.blogspot.com/2005/09/yet-another-curcumin-article.html
http://myelomic.blogspot.com/2005/08/curcumin-blocks-melanoma-and-myeloma.html

Australia approves Thalidomide for myeloma

Starting in February, Thalidomide is being made available under the Australian Pharmaceutical Benefits Scheme (PBS), for the treatment of multiple myeloma.

Royal Melbourne Hospital spokesman Dr Jeff Szer says six years of research has shown thalidomide is the most effective way of treating multiple myeloma.

"Every patient must give an understanding on how the drug can be used and, of course, keep it away from people it can harm ... that is pregnant women."

Europe grants orphan drug status for Amplimexon(R)

AmpliMed Corporation announced that the European Commission has granted an orphan product designation for Amplimed's lead drug, Amplimexon(TM) for the treatment of ovarian cancer.

Amplimexon is currently in clinical trials evaluating safety and efficacy in combination with gemcitabine in patients with malignant melanoma, in combination with Taxotere® for the treatment of lung, breast and prostate cancer and as a monotherapy for the treatment of refractory multiple myeloma.

DVd superiority over VAd

Pegylated liposomal doxorubicin, vincristine, and dexamethasone provide significant reduction in toxicity compared with doxorubicin, vincristine, and dexamethasone in patients with newly diagnosed multiple myeloma.

BACKGROUND: Pegylated liposomal doxorubicin has pharmacologic and safety advantages over conventional doxorubicin.
METHODS: For this noninferiority trial, 192 patients with newly diagnosed, active multiple myeloma were randomized to receive either combined pegylated liposomal doxorubicin (40 mg/m(2)) and vincristine (1.4 mg/m(2); maximum, 2.0 mg) as an intravenous infusion on Day 1 plus reduced-dose dexamethasone (40 mg) orally on Days 1-4 (DVd) (n = 97 patients) or combined vincristine (0.4 mg per day) and conventional doxorubicin (9 mg/m(2) per day) as a continuous intravenous infusion on Days 1-4 plus reduced-dose dexamethasone (VAd) (n = 95 patients) for at least 4 cycles. Treatment was repeated every 4 weeks until patients either achieved maximal response, disease progression, or unacceptable toxicity or underwent transplantation. The primary endpoints were response and toxicity.
RESULTS: Objective response rates (DVd, 44%; VAd, 41%), progression-free survival (hazard ratio, 1.11; P = 0.69), and overall survival (hazard ratio, 0.88; P = 0.67) were similar between the treatment groups. However, DVd was associated with significantly less Grade 3/4 neutropenia or neutropenic fever (10% vs. 24%; P = 0.01), a lower incidence of sepsis, and less antibiotic use. Compared with VAd, DVd also significantly decreased the need for central venous access (P < p =" 0.03)">

Rifkin RM, Gregory SA, Mohrbacher A, Hussein MA.

Rocky Mountain Cancer Centers, US Oncology, Denver, Colorado.

MMRF 4-Star Rating

Cancer Foundation Recognized 3rd Year Running for Outstanding Fiscal Management

The Multiple Myeloma Research Foundation (MMRF) announced today that for a third consecutive year, the MMRF has received a 4-star rating from Charity Navigator, America’s largest independent evaluator of charitable organizations. Fewer than 12 percent of the 1.5 million charities evaluated annually receive this distinction for two consecutive years.

The 4-star rating, the highest honor Charity Navigator bestows, goes to organizations operating with exceptional standards of fiscal responsibility. Spending only $3 to raise $100, the MMRF exceeds standards in cancer fundraising and outperforms most charities in America for responsible management and measurable results. More than 95 percent of the dollars raised goes toward research and related programming.

"To be evaluated by a credible third-party and found worthy of the public’s trust is essential to our success," said Scott Santarella, Executive Director and Chief Administrative Officer of the MMRF. "As an organization we feel an immense obligation to our donors to be responsible stewards of their support. This rating validates our efforts and we are proud to once again be recognized by Charity Navigator for our commitment toward fiscal responsibility."

In addition to the 4-star rating from Charity Navigator, the MMRF was the only cancer-related charity to recently receive the "A+" designation from the American Institute of Philanthropy, and is in compliance with all of the Better Business Bureau’s Wise Giving Alliance standards for charity accountability. Additionally, the MMRF has earned approval from the National Cancer Institute (NCI) for its research grants program, making it one of only nine private, charitable research organizations that meet the same rigorous scientific standards the NCI applies to its own grant issuing process.

Source www.multiplemyeloma.org

THALOMID(R) trial results announced

Independent Data Monitoring Committee review determines that the Phase III pivotal trial meets the pre-established efficacy-stopping rule for the primary endpoint of time to disease progression

Celgene Corporation today announced that an external Independent Data Monitoring Committee analysis of the multi-centered, randomized, placebo-controlled phase III study of combination thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma met the pre-specified p<0.0015 value for stopping the trial. The IDMC found time to disease progression -- the primary endpoint of this Phase III trial -- of 75.7 weeks versus 27.9 weeks (p=0.000065), plus progression-free survival of 55.7 weeks versus 24.3 weeks (p=0.0003) in patients receiving THALOMID plus dexamethasone compared to patients receiving dexamethasone alone.

Treatment assignments for patients currently on the trials will be unblinded and those currently not on THALOMID will have the opportunity to add THALOMID to their dexamethasone regimen.

The thalidomide phase III special protocol assessment trial included patients with previously untreated (first-line) multiple myeloma. Patients were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone. A total of 270 patients were randomized to receive thalidomide plus dexamethasone, or placebo plus dexamethasone, in this multi-centered clinical trial. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.

Patients treated with thalidomide and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone alone. These adverse drug events included insomnia, tremors, dizziness, peripheral neuropathy and constipation. Grade 3 or 4 adverse events reported included deep vein thrombosis (DVT) occurred in 10.3% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone, and pulmonary embolism (PE) occurred in 5.6% of patients treated with thalidomide plus dexamethasone, compared to 1.7% of patients treated with placebo plus dexamethasone alone.

Safety Notice
THALOMID(R) (thalidomide) Capsules 50 mg, 100 mg, & 200 mg
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the "System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.

Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Patients with neoplastic and various inflammatory conditions being treated with thalidomide in combination with other agents may have an increased incidence of thromboembolic events such as pulmonary embolism, deep vein thrombophlebitis, thrombophlebitis, or thrombosis. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide. Patients should be instructed to not extensively handle or open thalidomide capsules and to maintain storage of capsules in blister packs until ingestion.

This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.

SOURCE: Celgene Corporation website www.celgene.com

ZIO-101 phase I/II myeloma trial

Ziopharm Oncology, Inc. has received approval from the FDA to initiate a Phase I/II trial with ZIO-101, a novel organic arsenic, in patients with advanced myeloma.

Patient treatment is expected to start in early 2006 at leading cancer centres in the US, Canada, and UK. Completion of enrolment is expected by the end of 2006, followed by pivotal trials beginning mid-2007.

The company believes ZIO-101 has the potential to treat patients with myeloma at significantly higher doses compared to arsenic trioxide, an inorganic arsenic currently used to treat APL, which has also shown activity in myeloma. Currently in Phase I clinical trials, interim results on ZIO-101 were reported during a press conference at the AACR-NCI-EORTC International Conference in November 2005.

As announced, dosing of ZIO-101 was approximately 25 times higher (presently 35 times higher) than the approved dose of arsenic trioxide. The interim data reported evidence of meaningful benefit in one patient, and no significant toxicity. The Company believes a higher dose coupled with less toxicity will provide a wider therapeutic window and an incremental benefit, or treatment alternative, for myeloma patients, as newly approved agents continue to be associated with significant toxicities and/or drug resistance at therapeutic doses.

Keryx Commences Study of KRX-0401 for Refractory Myeloma

NEW YORK -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) announced today the initiation of a corporate-sponsored clinical program to evaluate KRX-0401 (perifosine) as a treatment for multiple myeloma. This follows positive pre-clinical data presented last month at the ASH Meeting where perifosine was shown to be active against human multiple myeloma cell lines and freshly isolated plasma cells from multiple myeloma patients' bone marrow, including those cells which were resistant to dexamethasone and doxorubicin. Perifosine was shown to modulate a number of key cellular functions involved in the replication and death of multiple myeloma cells, and, as in other cell lines, it was shown to be a potent Akt inhibitor. Perifosine was active in vitro and in vivo when used alone, and it appeared to be synergistic when combined with either bortezomib (Velcade®) or dexamethasone.

The clinical trial initiated today is entitled "An Open-Label Phase II Study of the Safety and Efficacy of Perifosine [KRX-0401] Alone and in Combination with Dexamethasone for Patients with Relapsed or Relapsed/Refractory Multiple Myeloma". This is a multi-center study led by Dr. Paul Richardson, Clinical Director of the Jerome Lipper Myeloma Center at the Dana-Farber Cancer Institute (DFCI) in Boston, MA.

In this Phase II study, patients with relapsed or relapsed/refractory multiple myeloma will be treated with KRX-0401 (150 mg oral daily dose) to assess the single agent activity of KRX-0401 in this patient population. If a patient progresses on KRX-0401 alone, dexamethasone (20mg twice weekly) will be added to their KRX-0401 regimen. This study is similar in design to the Velcade® pivotal Phase II program, the SUMMIT study, for which Paul Richardson also served as Principal Investigator.

Dr. Richardson stated, "KRX-0401 is a novel compound with a unique mechanism of action that has demonstrated compelling activity in what we believe are highly predictive multiple myeloma preclinical models. We are eager to explore its potential in treating and hopefully benefiting our patients with relapsed or relapsed/refractory myeloma."

Another Keryx-sponsored multiple myeloma clinical study to be launched in the first half of 2006 will be a DFCI -led phase I/II study evaluating the safety and efficacy of KRX-0401 and bortezomib (Velcade®) therapy with or without dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with bortezomib (Velcade®).

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (TSX: AEZ; Nasdaq: AEZS), in the United States, Canada and Mexico.

About KRX-0401 (Perifosine)

KRX-0401 is a novel, first-in-class, oral anticancer agent that modulates AKT and a number of other key signal transduction pathways, including the MAPK and JNK pathways. Perifosine has shown single agent partial responses or long term disease stablizations in solid tumors including sarcoma and prostate cancer.

KRX-0401, or perifosine, is the prototype of a new group of anti-cancer drugs referred to as alkylphosphocholines that block proliferation and induce the apoptosis of cancer cells. This effect is relatively specific for cancer cells compared to normal cells. The mechanism of action for these drugs is not clear. They are known to modulate signaling in a number of pathways known to function abnormally during the development of cancer. One of the pathways inhibited by the alkylphosphocholines is Akt, a pathway associated with tumor survival and growth. Akt is considered to be one of the most important cancer targets being researched today.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future the financial performance and clinical and business prospects for KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete the Phase 2 clinical trials for KRX-0401; we may not be able to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commissions. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.

Source: www.keryx.com

See also:

http://myelomic.blogspot.com/2005/12/perifosine-and-tipifarnib-increases.html
http://myelomic.blogspot.com/2005/12/krx-0401-perifosine-update-at-ash.html

Vitamin D cuts cancers

After my transplant I was put on a daily Vitamin D and calcium dose to maintain bone health, with no end in sight. Therefore I was interested to read this article in last week's newspaper.
***
Bloomberg news: Ingesting about three times as much vitamin D as normally suggested may lower an individual's risk of developing colon, breast or ovarian cancer, a study says.

Americans typically ingest 320 units a day of the vitamin, consisting of 200 from food and 120 from supplements. Daily intake of about 1,000 units may cut the odds of getting colon cancer by about half and chances of getting breast or ovarian cancer by about a third, according to researchers.

Vitamin D supplementation could reduce cancer incidence and mortality "at low cost, with few or no averse side-effects," the researchers said in an article appearing in the February issue of the American Journal of Public Health.

The substance involved is vitamin D3, usually called just vitamin D, the study said.