Gilead Offers Response Data from Idelalisib; Sangamo Highlights Encouraging Preliminary Anti-Viral HIV Data Print E-mail
By Staff and Wire Reports   
Wednesday, 15 May 2013 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 15, 2013.
Gilead Sciences, Inc. (Nasdaq: GILD) announced results from a Phase 2 study (Study 101-08) evaluating idelalisib (formerly GS-1101), an investigational, targeted, oral inhibitor of PI3K delta, in combination with rituximab for older patients with treatment-naïve chronic lymphocytic leukemia (CLL). This regimen achieved a complete response (CR) rate of 19 percent and an overall response rate (ORR) of 97 percent, with estimated progression-free survival (PFS) at 24 months of 93 percent. Detailed results will be presented during an oral session at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #7005).

CLL is a slow-growing cancer that induces the production of too many mature white blood cells. It is the second most common type of leukemia in the United States and can lead to life-threatening complications, including serious infection. Currently, patients with CLL are usually treated first with rituximab in combination with one or more chemotherapy agents.

Among the 64 patients in the study, Kaplan-Meier estimated PFS at 24 months was 93 percent. The median time on treatment was 14 months, with 33 patients remaining on treatment. The median time to response was two months. No relapses on study have been reported. The nine patients with chromosome 17p deletion (del 17p) (n=6) or mutation in the TP53 gene (n=3), which have been linked to poor prognosis, all responded to therapy including three with a complete response. Ninety-four percent of patients with thrombocytopenia at baseline responded to treatment (16/17), as did all patients with anemia at baseline (17/17). Of patients with systemic symptoms such as extreme fatigue, fever, night sweats or weight loss (known as “B symptoms”) at baseline, 77 percent (20/26) were asymptomatic by eight weeks.

Patients completing 48 weeks of therapy without progression could continue to receive idelalisib in an extension study. Forty-three patients completed 48 weeks of treatment (21 discontinued – 17 due to adverse events, three due to death and one due to other reasons); 40 patients entered the extension study and 33 remain on treatment.

During the primary and extension study, Grade 3 diarrhea and/or colitis was reported in 33 percent of patients, Grade ≥3 pneumonia in 17 percent and Grade ≥3 transaminase elevations (measure of liver function) in 23 percent of patients.


======


Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced the presentation of new clinical data from its program to develop a ZFP Therapeutic® for HIV/AIDS.  The data, which demonstrate that SB-728-T treatment results in a reduction in the HIV reservoir in HIV-infected subjects, are being presented at the 16th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT).  The meeting is being held in Salt Lake City from May 15-18, 2013.

HIV-infected subjects enrolled in Sangamo's ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T which resulted in a durable increase in total CD4 T-cells driven by increased ZFN-modified CD4 central memory T-cells.  The extent of exposure of subjects to circulating zinc finger nuclease (ZFN) CCR5 protected CD4 T cells correlated with a long term decrease in the peripheral blood mononuclear cell (PBMC) HIV reservoir as measured by proviral DNA.  In addition, two of four evaluable subjects in Cohort 5 of this study showed a decrease of greater than one log in their viral load during a sixteen week treatment interruption (TI) with one of the subjects achieving a transiently undetectable viral load during the TI period. In subjects in which viral load decreased, a measureable anti-HIV response was observed, specifically a multi-functional response of CD8 T-cells to elements of HIV core proteins.

Summary of Clinical Data

SB-728-0902 Cohorts 1-3 in Immunologic Non-Responders (INR)

o Treatment of HIV subjects with a single infusion of SB-728-T leads to long term increases in CD4 counts (up to 3 years in some subjects). o Long-term increases in CD4 counts correlate with increased CD4 central memory and increased ZFN CCR5 protected central memory T-cells. o The extent of long-term exposure to circulating ZFN-CCR5 protected CD4 cells correlates with long-term decreases in the PBMC HIV reservoir.

SB-728-0902 Cohort 5 (CCR5 delta-32 Heterozygotes)

o Post SB-728-T infusion, a 16-week ART TI can lead to viral load reduction from initial peak.

o Two out of four subjects showed reduction in viral load during TI o One subject achieved transient undetectable viral load during TI

o The best viral load reduction responses are seen in subjects with CD8 T-cell HIV gag immune responses that are polyfunctional (expression of multiple cytokines) and the highest levels of bi-allelic modification of the CCR5 gene.

SB-728-1101 Immunologic Responders with Cytoxan Conditioning

o Accrual and treatment in progress with ten subjects infused to date. o Analysis of numbers of modified SB-728-T cells and viral load during TI is in progress.

Viral load decreases correlate with highest levels of estimated biallelic CCR5 modification

o Decreases in viral load from peak to the end of TI correlated with mean circulating bi-allelic ZFN CCR5 protected CD4 cells during the TI for all patients to date who fully completed TI per protocol in SB-728-Penn, 902 Cohort 5(CCR5 delta-32 Heterozygotes) and 1101 studies.


Also Wednesday:



AbbVie (NYSE: ABBV)
today announced that data evaluating several investigational compounds in the company's oncology pipeline will be presented at the upcoming 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 - June 4, Chicago.

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
today announced the pricing of an underwritten public offering of 8,000,000 shares of its common stock, offered at a price to the public of $12.50 per share.

Amgen (NASDAQ: AMGN)
today announced that it will present data from several studies of both pipeline and marketed products at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.

Arno Therapeutics, Inc. (OTCQB: ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced new, positive data from three studies supporting its investigational compound onapristone to be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting, which is being held May 31-June 4, 2013 in Chicago, Illinois.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, the Breast Health Company™, today announced its first quarter 2013 financial results and corporate developments.

Bioheart, Inc. (OTCQB: BHRT)
announced today that Ms. Evelyn Flores will join Bioheart as Corporate Controller.

Bovie Medical Corporation (NYSE MKT: BVX)
, a manufacturer and marketer of electrosurgical products, today announced its financial results for the first quarter ended March 31, 2013.

Crown Marketing (OTCQB: CWNM)
is pleased to announce that its subsidiary, Crown Nutraceuticals, has begun sales of its two popular diet products: Raspberry Ketones and Green Coffee Bean Extract.

DaVita®, a division of DaVita HealthCare Partners Inc. (NYSE: DVA) and a leading provider of kidney care services, today announced that the company’s subsidiary, Patient PathwaysSM, received the Dorland Health “Case In Point” Platinum Award for best Discharge Planning program in the U.S.

Dyadic International, Inc. (OTC Pink: DYAI)
, a  global biotechnology company, today announced financial results for the quarter ended March 31, 2013.

Discovery Laboratories, Inc. (NASDAQ: DSCO)
today announced that it has completed its previously announced public offering to sell an aggregate of 9.5 million shares of its common stock under Discovery Labs' previously filed registration statement that was declared effective by the Securities and Exchange Commission on June 21, 2011.

FONAR Corporation (NASDAQ: FONR)
, The Inventor of MR Scanning™, reported its 3rd quarter fiscal 2013 and nine month financial results today, for the period ended March 31, 2013.

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
, today announced that important new data from clinical trials of several investigational and approved cancer medicines will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 31 to June 4, 2013, in Chicago.

Halozyme Therapeutics, Inc. (NASDAQ: HALO)
today announced that clinical data from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for treatment of patients with stage IV metastatic pancreatic cancer will be presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA)
today reported financial results for the quarter ended March 31, 2013.

IsoRay, Inc. (NYSE MKT: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer, lung cancer, head and neck cancer, prostate cancer and gynecologic ("gyn") cancer, announced its financial results for the quarter and nine months ended March 31, 2013.

Microlog Corporation (PINKSHEETS: MLOG)
is pleased to announce that it has entered into a definitive agreement (the "Agreement") with NutraBev Holdings International, Inc., a leading nutrition and natural foods company based in Syosset, New York ("NutraBev"), under which NutraBev will be acquired by Microlog.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that the Company's primary business will be expanded from its previous focus of selling consumer and professional products and services, including its MyMedicalRecords PHR and MMRPro document imaging and scanning systems, to equally exploiting and licensing its health information technology patents domestically and internationally.

MusclePharm Corporation (OTCQB: MSLP)
, a fast growing company that develops and markets sports nutritional supplements which address active lifestyles, announced today its financial results for the first quarter ended March 31, 2013 ("Q1 2013").

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the company was honored by the National Organization for Rare Disorders (NORD) for the FDA approval of Gattex® (teduglutide [rDNA origin]) for injection, which is indicated for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced the upcoming presentations of data highlighting Nexavar® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection, and Stivarga® (regorafenib) tablets across a range of cancers.

OvaScienceSM, (NASDAQ: OVAS)
, a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today reported financial results for the quarter ended March 31, 2013, and highlighted the Company’s recent achievements.

PLC Systems Inc. (OTCBB: PLCSF)
, a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three months ended March 31, 2013.

Sinovac Biotech Ltd. (NASDAQ: SVA)
, a leading provider of biopharmaceutical products in China, has appointed China-based Ernst & Young Hua Ming LLP as its registered independent public accounting firm effective from May 14, 2013 to replace Ernst & Young LLP Canada.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has initiated the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.

Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA)
, a biopharmaceutical company developing therapeutic products for rare diseases, joins the International MPS Network and others around the world in observing MPS Awareness Day 2013.

Vermillion, Inc. (NASDAQ: VRML)
, a molecular diagnostics company focused on gynecologic cancers and women's health, reported on its financial results for the first quarter ended March 31, 2013.unced results from a Phase 2 study (Study 101-08) evaluating idelalisib (formerly GS-1101), an investigational, targeted, oral inhibitor of PI3K delta, in combination with rituximab for older patients with treatment-naïve chronic lymphocytic leukemia (CLL). This regimen achieved a complete response (CR) rate of 19 percent and an overall response rate (ORR) of 97 percent, with estimated progression-free survival (PFS) at 24 months of 93 percent. Detailed results will be presented during an oral session at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #7005). CLL is a slow-growing cancer that induces the production of too many mature white blood cells. It is the second most common type of leukemia in the United States and can lead to life-threatening complications, including serious infection. Currently, patients with CLL are usually treated first with rituximab in combination with one or more chemotherapy agents. Among the 64 patients in the study, Kaplan-Meier estimated PFS at 24 months was 93 percent. The median time on treatment was 14 months, with 33 patients remaining on treatment. The median time to response was two months. No relapses on study have been reported. The nine patients with chromosome 17p deletion (del 17p) (n=6) or mutation in the TP53 gene (n=3), which have been linked to poor prognosis, all responded to therapy including three with a complete response. Ninety-four percent of patients with thrombocytopenia at baseline responded to treatment (16/17), as did all patients with anemia at baseline (17/17). Of patients with systemic symptoms such as extreme fatigue, fever, night sweats or weight loss (known as “B symptoms”) at baseline, 77 percent (20/26) were asymptomatic by eight weeks. Patients completing 48 weeks of therapy without progression could continue to receive idelalisib in an extension study. Forty-three patients completed 48 weeks of treatment (21 discontinued – 17 due to adverse events, three due to death and one due to other reasons); 40 patients entered the extension study and 33 remain on treatment. During the primary and extension study, Grade 3 diarrhea and/or colitis was reported in 33 percent of patients, Grade ≥3 pneumonia in 17 percent and Grade ≥3 transaminase elevations (measure of liver function) in 23 percent of patients. ====== Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced the presentation of new clinical data from its program to develop a ZFP Therapeutic® for HIV/AIDS. The data, which demonstrate that SB-728-T treatment results in a reduction in the HIV reservoir in HIV-infected subjects, are being presented at the 16th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). The meeting is being held in Salt Lake City from May 15-18, 2013. HIV-infected subjects enrolled in Sangamo's ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T which resulted in a durable increase in total CD4 T-cells driven by increased ZFN-modified CD4 central memory T-cells. The extent of exposure of subjects to circulating zinc finger nuclease (ZFN) CCR5 protected CD4 T cells correlated with a long term decrease in the peripheral blood mononuclear cell (PBMC) HIV reservoir as measured by proviral DNA. In addition, two of four evaluable subjects in Cohort 5 of this study showed a decrease of greater than one log in their viral load during a sixteen week treatment interruption (TI) with one of the subjects achieving a transiently undetectable viral load during the TI period. In subjects in which viral load decreased, a measureable anti-HIV response was observed, specifically a multi-functional response of CD8 T-cells to elements of HIV core proteins. Summary of Clinical Data SB-728-0902 Cohorts 1-3 in Immunologic Non-Responders (INR) o Treatment of HIV subjects with a single infusion of SB-728-T leads to long term increases in CD4 counts (up to 3 years in some subjects). o Long-term increases in CD4 counts correlate with increased CD4 central memory and increased ZFN CCR5 protected central memory T-cells. o The extent of long-term exposure to circulating ZFN-CCR5 protected CD4 cells correlates with long-term decreases in the PBMC HIV reservoir. SB-728-0902 Cohort 5 (CCR5 delta-32 Heterozygotes) o Post SB-728-T infusion, a 16-week ART TI can lead to viral load reduction from initial peak. o Two out of four subjects showed reduction in viral load during TI o One subject achieved transient undetectable viral load during TI o The best viral load reduction responses are seen in subjects with CD8 T-cell HIV gag immune responses that are polyfunctional (expression of multiple cytokines) and the highest levels of bi-allelic modification of the CCR5 gene. SB-728-1101 Immunologic Responders with Cytoxan Conditioning o Accrual and treatment in progress with ten subjects infused to date. o Analysis of numbers of modified SB-728-T cells and viral load during TI is in progress. Viral load decreases correlate with highest levels of estimated biallelic CCR5 modification o Decreases in viral load from peak to the end of TI correlated with mean circulating bi-allelic ZFN CCR5 protected CD4 cells during the TI for all patients to date who fully completed TI per protocol in SB-728-Penn, 902 Cohort 5(CCR5 delta-32 Heterozygotes) and 1101 studies. Also Wednesday: AbbVie (NYSE: ABBV) today announced that data evaluating several investigational compounds in the company's oncology pipeline will be presented at the upcoming 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 - June 4, Chicago. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced the pricing of an underwritten public offering of 8,000,000 shares of its common stock, offered at a price to the public of $12.50 per share. Amgen (NASDAQ: AMGN) today announced that it will present data from several studies of both pipeline and marketed products at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago. Arno Therapeutics, Inc. (OTCQB: ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced new, positive data from three studies supporting its investigational compound onapristone to be presented at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting, which is being held May 31-June 4, 2013 in Chicago, Illinois. Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company™, today announced its first quarter 2013 financial results and corporate developments. Bioheart, Inc. (OTCQB: BHRT) announced today that Ms. Evelyn Flores will join Bioheart as Corporate Controller. Bovie Medical Corporation (the "Company") (NYSE MKT: BVX), a manufacturer and marketer of electrosurgical products, today announced its financial results for the first quarter ended March 31, 2013. Crown Marketing (OTCQB: CWNM) is pleased to announce that its subsidiary, Crown Nutraceuticals, has begun sales of its two popular diet products: Raspberry Ketones and Green Coffee Bean Extract. DaVita®, a division of DaVita HealthCare Partners Inc. (NYSE: DVA) and a leading provider of kidney care services, today announced that the company’s subsidiary, Patient PathwaysSM, received the Dorland Health “Case In Point” Platinum Award for best Discharge Planning program in the U.S. Dyadic International, Inc. (OTC Pink: DYAI), a global biotechnology company, today announced financial results for the quarter ended March 31, 2013. Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced that it has completed its previously announced public offering to sell an aggregate of 9.5 million shares of its common stock under Discovery Labs' previously filed registration statement that was declared effective by the Securities and Exchange Commission on June 21, 2011. FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported its 3rd quarter fiscal 2013 and nine month financial results today, for the period ended March 31, 2013. Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that important new data from clinical trials of several investigational and approved cancer medicines will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 31 to June 4, 2013, in Chicago. Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that clinical data from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for treatment of patients with stage IV metastatic pancreatic cancer will be presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today reported financial results for the quarter ended March 31, 2013. IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for brain cancer, lung cancer, head and neck cancer, prostate cancer and gynecologic ("gyn") cancer, announced its financial results for the quarter and nine months ended March 31, 2013. Microlog Corporation ("Microlog") (PINKSHEETS: MLOG) is pleased to announce that it has entered into a definitive agreement (the "Agreement") with NutraBev Holdings International, Inc., a leading nutrition and natural foods company based in Syosset, New York ("NutraBev"), under which NutraBev will be acquired by Microlog. MMRGlobal, Inc. (OTCQB: MMRF) ("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that the Company's primary business will be expanded from its previous focus of selling consumer and professional products and services, including its MyMedicalRecords PHR and MMRPro document imaging and scanning systems, to equally exploiting and licensing its health information technology patents domestically and internationally. MusclePharm Corporation (OTCQB: MSLP), a fast growing company that develops and markets sports nutritional supplements which address active lifestyles, announced today its financial results for the first quarter ended March 31, 2013 ("Q1 2013"). NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the company was honored by the National Organization for Rare Disorders (NORD) for the FDA approval of Gattex® (teduglutide [rDNA origin]) for injection, which is indicated for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced the upcoming presentations of data highlighting Nexavar® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection, and Stivarga® (regorafenib) tablets across a range of cancers. OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today reported financial results for the quarter ended March 31, 2013, and highlighted the Company’s recent achievements. PLC Systems Inc. (OTCBB: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported financial results for the three months ended March 31, 2013. Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, has appointed China-based Ernst & Young Hua Ming LLP as its registered independent public accounting firm effective from May 14, 2013 to replace Ernst & Young LLP Canada. Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it has initiated the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA), a biopharmaceutical company developing therapeutic products for rare diseases, joins the International MPS Network and others around the world in observing MPS Awareness Day 2013. Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and women's health, reported on its financial results for the first quarter ended March 31, 2013.



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