[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather
Santa Clarita CA
Cloudy
Cloudy
69°F
 
Calendar
Today in
S.C.V. History
December 15
1987 - Incorporation: Santa Clarita officially becomes a city [story]


Valencia-based MannKind Corp. announced Friday it has completed recruiting patients for two Phase 3 clinical studies of Afrezza (insulin human [rDNA origin]), an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s to-be-marketed next-generation inhaler.

The first of these studies (study 171) is an open-label study in patients with type 1 diabetes. After a run-in period, during which all patients are optimized on their basal insulin regimen, at least 471 subjects are to be randomized to one of three arms for mealtime insulin: a control arm, in which patients utilize injected rapid-acting insulin, or one of two Afrezza arms, one for the MedTone inhaler and the other for the next-generation inhaler. After the mealtime insulin is titrated, there is a 12-week observation period on stable doses of the mealtime insulin to assess HbA1c levels, which is the primary outcome parameter. Another objective of this study is to compare the safety profile of the two Afrezza treatment groups.

The other study (study 175) is assessing Afrezza using the next-generation inhaler in patients with type 2 diabetes whose disease is inadequately controlled on metformin with or without a second or third oral medication. After a run-in period during which the subjects remain on their oral medication, at least 328 patients will be randomized to additional treatment with Afrezza or to Technosphere inhalation powder (placebo). The study will also have a titration period, followed by a 12-week evaluation period to assess HbA1c levels.

“Completing patient recruitment is the initial element, and often the lengthiest, in the conduct of large scale Phase 3 clinical trials,” said Alfred Mann, Chairman and Chief Executive Officer. “Both studies are on track to be completed in the second quarter of 2013 and we expect to report top-line results next summer. Our objective is to resubmit the NDA for Afrezza in the third quarter of next year.”

 

About Afrezza

Afrezza is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corp. for the treatment of adult patients with type 1 or type 2 diabetes for the control of hyperglycemia. It is a drug-device combination product, consisting of Afrezza Inhalation Powder, pre-metered into single-use cartridges, and a light, discreet and easy-to-use inhaler. Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the Afrezza clinical program has involved 61 different clinical studies and over 5,600 adult patients.

 

About MannKind Corp.

MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its lead product candidate, Afrezza, is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


Latest Additions to SCVNews.com
The National Weather Service has called a Fire Weather Watch for this weekend for Los Angeles and Ventura County mountains and valleys including the Santa Clarita Valley due to gusty northeast wind and low relative humidity.
Weekend Fire Weather Watch Called for SCV
Santa Clarita Valley Sheriff's Station deputies arrested a 21-year-old man who had an outstanding warrant and was allegedly in possession of cocaine in Canyon Country early Thursday.
Bicyclist Arrested for Warrant, Cocaine in Canyon Country
Valencia-based Princess Cruises, voted the #1 international cruise line in Japan, announced its 2019 program featuring Japanese-built Diamond Princess returning for her sixth season, sailing roundtrip from Tokyo (Yokohama) and Kobe.
Princess Cruises Unveils 2019 Japan Cruise Program
Valencia-based Princess Cruises released its 2019 Canada and New England cruise schedule, featuring Regal Princess and Caribbean Princess on the line’s largest fall deployment and the opportunity to visit Greenland roundtrip from New York
Princess Cruises Sets Fall 2019 Cruises to Canada, New England
The Los Angeles County Sheriff's Department looks back at five years of work by its Domestic Highway Enforcement Team, which has disrupted the operations of the drug cartels by confiscating millions of dollars in illegal drugs and drug money.
Elite LASD Drug Enforcement Team Disrupts Cartel Operations
College of the Canyons quarterback Andrew Brito, wide receiver Desean Holmes and linebacker KJ Latu have been named to the 2017 Region III All-California Community College Football Team.
Brito, Holmes, Latu Represent Cougars on All-State Team
Tickets and sponsorships are now available for the Santa Clarita Valley Chamber of Commerce's 2018 awards ceremony and installation of new officers at Tournament Players Club in Valencia on Friday night, January 26.
Jan. 26: SCV Chamber of Commerce 2018 Awards, Installation Gala
Sponsorships are now open for the Santa Clarita Valley Economic Development Corporation's 2018 Economic Outlook Conference, set for Thursday, March 8, 2018 at a location to be announced shortly.
SCV 2018 Economic Outlook Conference Tickets, Sponsorships Open
SetPoint Medical, a Valencia-based biomedical company developing therapy for chronic inflammatory diseases, has received approval from the FDA to initiate a pilot trial in the U.S. for patients with drug-refractory rheumatoid arthritis.
FDA OK’s SetPoint Bioelectronic Therapy Study for Rheumatoid Arthritis
Governor Edmund G. Brown Jr., representing the United States - and states and regions leading on climate across the globe - joined world leaders at the One Planet Summit Tuesday, the two-year anniversary of the Paris Agreement.
Brown in Paris: ‘We Can’t Wait for White House to Wake Up’
The regular Planning Commission meeting scheduled for Tuesday, December 19 has been canceled, according to a notification from the city of Santa Clarita today.
City Cancels Dec. 19 Planning Commission Meeting
The next meeting of the Los Angeles County Board of Supervisors is set for Tuesday, December 19, starting at 9:30 a.m.
Dec. 19: L.A. County Board of Supervisors Meeting
L.A. County's Bringing Our Loved Ones Home Task Force officials unveiled their final recommendations, endorsing a plan to use a voluntary system of trackable bracelets to find people prone to wandering, like those suffering from Alzheimer’s or autism.
County Task Force Calls for Tracking Bracelets to Locate Lost Individuals
The Community Development Commission of the county of Los Angeles looks back on 35 years of advancing its core program areas: affordable housing and housing, community and economic development.
County Community Development Commission Marks 35th Anniversary
Metro is seeking two new members to join the Measure M Independent Taxpayer Oversight Committee.
Metro Seeks 2 New Measure M Oversight Committee Members
The California Air Resources Board approved a $663 million low-carbon transportation plan Thursday to increase the use of clean cars, heavy-duty trucks, buses and freight equipment.
Air Resources Board OK’s $663 Million for Clean Vehicles
The Santa Clarita Valley Sheriff's Station has released its public safety and crime information report for Saugus (Zone 4) for December 4-10, 2017.
Crime Blotter: Shoplifting, Petty Theft in Saugus
California Attorney General Xavier Becerra has filed his strong opposition to the Trump Administration’s illegal attempt to suspend the 2015 Clean Water Rule for two years.
California AG, 10 Others Oppose Feds’ Suspension of Clean Water Rule
Conservation groups on Friday lobbied a federal judge for permission to join a fight between the federal government and a ranching association over a trio of California amphibian species.
Conservationists Lobby to Join Fray Over Frog Habitat
1987 - Incorporation: Santa Clarita officially becomes a city [story]
With an offense that challenged the program’s single-season goals record, The Master’s University women’s soccer team was almost almost never out of any game it played: The Mustangs were always within striking range.
Lady Mustangs Within Range of Directors’ Cup Top Spots
When Ed Jackiewicz met Tera Trujillo in spring 2015, she was studying at a desk she’d carried to the corner of the California State University, Northridge soccer field, in a “time out” of sorts, unable to practice because she’d just earned a D in an economics class.
CSUN’s “Under Armour Faculty” Promotes Academic Success in Student-Athletes
When Rafael Munoz recalls his time at the Layer 8 Computer Security Club at California State University, Northridge, he feels proud and thankful.
CSUN’s Tech Education Makes Top 10 List
The city of Santa Clarita Arts and Events division is currently seeking proposals for solo exhibits for 2018 in the gallery space at The MAIN, the City’s newest arts venue in Old Town Newhall.
City Seeking Artists for 2018 Solo Exhibits
NORTHRIDGE, Calif.---CSUN Men's Basketball returns to the road for the final time in the non-conference season this weekend.
CSUN to Face-Off Against Formal Rival Eastern Washington
Here is a list of Santa Clarita arts-related events for Friday:
Dec. 15: Santa Clarita Arts Calendar
This Friday and Saturday (Dec. 15-16), The Sharon Disney Lund School of Dance brings their annual Winter Dance Concert to the REDCAT stage.
Dec. 15, 16: Sharon Disney Lund School of Dance Concert at REDCAT
The William S. Hart Union High School District Governing Board has approved naming Dr. Collyn Nielsen as Chief Administrative Officer and Jan Hayes-Rennels as Director of Special Programs and Staff Development.
Hart Appoints Nielsen, Hayes-Rennels to District Office Positions
NORTHRIDGE, Calif. - The CSUN men's volleyball team was picked to finish third in the inaugural Big West Men's Volleyball Preseason Coaches Poll announced Thursday.
Big West Pre-Season Coaches Poll Puts Matadors Volleyball at No. 3
A 44-year-old transient was arrested by SCV Sheriff's Station deputies Wednesday afternoon after he allegedly tried to pick up his 8-year-old niece from a school in Santa Clarita.
Suspect Arrested in Attempted Kidnapping
It was a night to honor exceptional mentors at California State University, Northridge, but the five recipients of the 2017 Don Dorsey Excellence in Mentoring Awards just wanted to talk about their students.
CSUN Pays Tribute to Mentors Who Have Made a Difference
The words leapt right off the page and hung in the air, heavy, encircling the audience. Their creator stood, offering his gifts of verse — shared in a powerful baritone voice.
Literary Star Power Comes to CSUN
While critical fire conditions continue through Friday, the final numbers for the Rye Fire have been released.
Officials Release Final Numbers on Rye Fire
The William S. Hart Union High School District Governing Board held it’s annual reorganizational meeting Wednesday night, naming Steve Sturgeon as Board President.
Steve Sturgeon Named 2018 Hart Board President
Castaic Elementary School is collecting gently used children's clothing and toys for the victims of the Creek Fire in Sylmar.
Local School Collecting Clothes, Toys for Creek Fire Victims
Gusty Santa Ana winds fanned the Thomas Fire's eastern flank Thursday, prompting officials to call for mandatory evacuations for areas near Fillmore.
Officials Issue Evacuation Orders for Fillmore Residents