Navigation Links
FDA Grants GeoVax Labs, Inc. Request For Pre-IND Meeting
Date:11/17/2009

ATLANTA, Nov. 17 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX) (the "Company"), an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today announced that the U.S. Food and Drug Administration (FDA) has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for GeoVax's therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package. Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial.

Robert McNally, Ph.D., president and chief executive officer, stated, "In anticipation of a pre-IND meeting in mid December, we have submitted a pre-IND information packet to the FDA. This packet includes rationale and supporting data for each question in the pre-IND package to allow a response from the FDA. The main purpose of the Pre-IND meeting is to ensure the FDA understands the purpose, approach and endpoints for the anticipated Phase 1 therapeutic trial and that we have answers to all of our questions to the FDA prior to filing the actual IND.

"While there are no guarantees of success for our therapeutic IND package, the pre-IND process helps ensure that our IND will adequately address any concerns the FDA may have about the proposed therapeutic trial," Dr. McNally added. "We understand the extreme need for this vaccine and we understand the process necessary to navigate forward."

A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The Phase 1 therapeutic protocol stresses safety parameters
'/>"/>

SOURCE GeoVax Labs, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Ganeden Biotech Announces Grants for Early Investigators to Research Probiotic GanedenBC30
2. Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
3. Octapharma Accepting Applications for Research Grants on Immunotherapy, Coagulation Disorders and Critical Care
4. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
5. Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations
6. Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA
7. Rendell Administration Announces Health Research Grants From Tobacco Settlement Funds
8. FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
9. Susan G. Komen for the Cure(R) Makes Unprecedented Research and Local Program Grants
10. KGI Professor Ian Phillips Awarded Defense Grants for Medical Combat Research
11. Immigrants From India, Pakistan Face U.S. Prostate, Breast Cancer Risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... LONDON , December 24, 2014 ... grow at an average rate of 8.1%. The US ... Hip, knee and spine surgeries are the common orthopedic ... they have a lower penetration. Increased number of product ... composites. Non-metallic orthopedic devices have gained popularity in the ...
(Date:12/24/2014)... DALLAS , December 24, 2014 /PRNewswire/ ... Research Report on Global Disposable Syringe Industry ... to its online business intelligence library. ... Global Disposable Syringe Industry is a professional ... Syringe market.  For overview analysis, the report ...
(Date:12/24/2014)... China , Dec. 23, 2014 ... pharmaceutical company that specializes in patented biopharmaceutical, modernized ... pharmaceutical ingredients (API) today announced that the Company ... its Good Manufacturing Practice (GMP) certificate of TPI,s ... Drug Administration,s (CFDA). The public notice period is ...
Breaking Medicine Technology:Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 2Use of Composites in Orthopedic Industry to Reach $596 Million by 2020 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 2World Disposable Syringe Market 2014 Report: China and Regional Analysis 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 4World Disposable Syringe Market 2014 Report: China and Regional Analysis 5TPI QLF Achieved Public Notice Status of GMP Certification 2TPI QLF Achieved Public Notice Status of GMP Certification 3
... options and research directions , , WASHINGTON, June ... therapeutic option for many patients with interstitial cystitis (IC). IC ... 8 million women and 1.5 million men in the United ... noticed a correlation between allergies and IC. Recently, a urologist ...
... Families of Spinal Muscular Atrophy has just released details ... funded therapeutic pipeline. , , Families of SMA ... Quinazolines to boost gene expression; 2) Tetracyclines at Paratek ... replacement program at California Stem Cell and UCI. ...
Cached Medicine Technology:Urologist and Allergist Explore Link Between Allergies and Interstitial Cystitis 2Urologist and Allergist Explore Link Between Allergies and Interstitial Cystitis 3Urologist and Allergist Explore Link Between Allergies and Interstitial Cystitis 4Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs 2Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs 3
(Date:12/25/2014)... HealthDay Reporter WEDNESDAY, Dec. 24, 2014 (HealthDay ... of youth" drug that can delay the effects of aging ... suggests. Seniors received a significant boost to their immune ... pathway linked to aging and immune function, researchers with the ... a version of the drug rapamycin, improved the seniors, immune ...
(Date:12/25/2014)... Carolina (PRWEB) December 25, 2014 ... Carolina Retirement Community, recently showed their generous spirit ... of the Catawba County Parenting Network- Grandparents Raising ... 10 children gathered around the largest Christmas tree ... open presents purchased by residents of the Abernethy ...
(Date:12/24/2014)... finds applications in a large number of fields of ... and research for metabolic and genetic disorders. It is ... techniques for the discovery and development of cancer biomarkers. ... growing worldwide. In 2012, there were 14.1 million new ... people living with cancer (within five years of diagnosis) ...
(Date:12/24/2014)... (PRWEB) December 24, 2014 Dr. Vu ... the expansion of his practice and med-spa with the ... practice’s growing list of cosmetic treatments and services. , ... into the skin,” says Dr. Ho. “As a result ... such as wrinkles, sun spots, discolorations or blemishes.” , ...
(Date:12/24/2014)... 2014 Mike Billings , PT, ... Derek Fenwick, PT, MBA, GCS, Director of Professional ... from the passing of the Improving Medicare Post-Acute ... this taping of the Infinicast, the two leaders discuss ... Social Security Act to standardize post-acute assessment data for ...
Breaking Medicine News(10 mins):Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 2Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 3Health News:Retirement Community Residents Make Impact During Holiday Season 2Health News:Global Epigenetics Market Was Valued at $413.24 Million in 2014 - New Research Report by MarketsandMarkets 2Health News:Global Epigenetics Market Was Valued at $413.24 Million in 2014 - New Research Report by MarketsandMarkets 3Health News:Dr. Vu Ho Expands Facial Plastic Surgery Practice to Include New Skin Care Treatment 2Health News:Latest Episode of Infinicast Features Infinity Rehab President Discussing IMPACT Act of 2014 and Changes for Post-Acute Therapy Providers in 2015 2
... the community-based model of directly observed therapy (DOT) ... improves patient survival. This is according to researchers ... Health, in collaboration with colleagues at University of ... randomized controlled trial of patient-nominated treatment-supporters providing partial ...
... CORVALLIS, Ore. Researchers have discovered a new strain ... and effectively help degrade polycyclic aromatic hydrocarbons, or PAHs ... harmful aspects of oil spills. Because of its ... considerable value in the long-term cleanup of the massive ...
... half of patients hospitalized with bipolar disorder may suffer ... with the psychiatric condition the more likely they are ... Michigan State University study. The study, led by ... bipolar disorder, a condition sometimes called manic-depressive disorder and ...
... belong to a youth club, they gain a stronger sense ... University study has revealed. The study suggests that even ... keeping children out of trouble. "The more kids participate ... Dawn Anderson-Butcher, an associate professor of social work at Ohio ...
... INDIANAPOLIS The Indiana Network for Patient Care (INPC), ... the United States, is expanding to include post-acute care ... to a growing number of individuals who often have ... facilities, part of Golden Living, the leading provider of ...
... -- The combination of decitabine and carboplatin appears to improve ... an upcoming issue of the journal Cancer (online ... participated in a phase I clinical trial had no disease ... resolution of tumor tissue for a period of time. ...
Cached Medicine News:Health News:Directly observed HIV treatment by patient-nominated treatment supporter improves survival 2Health News:New strain of bacteria discovered that could aid in oil spill, other environmental cleanup 2Health News:New strain of bacteria discovered that could aid in oil spill, other environmental cleanup 3Health News:MSU researcher identifies links between hypertension, bipolar disorders 2Health News:Youth clubs strengthen kids' self image to keep them out of trouble 2Health News:Youth clubs strengthen kids' self image to keep them out of trouble 3Health News:Improving care for older adults 2Health News:Improving care for older adults 3Health News:Late-stage ovarian cancer shows promise in 2-drug phase I trial 2Health News:Late-stage ovarian cancer shows promise in 2-drug phase I trial 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: